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Reenvisioning Clinical Science: Unifying the Discipline to Improve the Public Health
Abstract
We present a vision of clinical science, based on a conceptual framework of intervention development endorsed by the Delaware Project. This framework is grounded in an updated stage model that incorporates basic science questions of mechanisms into every stage of clinical science research. The vision presented is intended to unify various aspects of clinical science toward the common goal of developing maximally potent and implementable interventions, while unveiling new avenues of science in which basic and applied goals are of equally high importance. Training in this integrated, translational model may help students learn how to conduct research in every domain of clinical science and at each stage of intervention development. This vision aims to propel the field to fulfill the public health goal of producing implementable and effective treatment and prevention interventions.
... pilot/feasibility, proof-of-concept) have received heightened attention for their role in developing behavioral interventions [1][2][3][4]. During this time, translational science models, such as the National Institutes of Health (NIH) Stage Model [5] and the Obesity-Related Behavioral Intervention Trials (ORBIT) model [4], were created. Both models outline a sequenced and scoped series of studies where interventionists conceptualize, design, and test one or more intervention components, and where necessary, refine and retest an intervention. ...
... Two questions were asked only of respondents who indicated they had reviewed external grants in the past 5 years (Q9 and Q63). Survey questions were based upon published work exploring health behavior intervention scaling [4,5,7,8,14,16,17] and covered six broad domains: (i) PI characteristics and experiences conducting preliminary studies, (ii) designing preliminary studies, (iii) evidence produced in preliminary studies, (iv) interpreting the results of preliminary studies, (v) publishing preliminary studies, and (vi) funding for preliminary studies. Alignment between survey questions and the six domains is presented in Supplementary Appendix C. ...
... Funding bodies such as the NIH place an emphasis on the use of guidelines and frameworks during the development of preliminary studies, but a recent scoping review indicates frameworks and guidelines are cited infrequently in published preliminary studies [1,[3][4][5]. The low citation rate of frameworks may indicate PIs lack awareness of guidelines and frameworks promoting iterative study development within their field. ...
Preliminary studies play a prominent role in the development of large-scale behavioral interventions. Though recommendations exist to guide the execution and interpretation of preliminary studies, these assume optimal scenarios which may clash with realities faced by researchers. The purpose of this study was to explore how principal investigators (PIs) balance expectations when conducting preliminary studies. We surveyed PIs funded by the National Institutes of Health to conduct preliminary behavioral interventions between 2000 and 2020. Four hundred thirty-one PIs (19% response rate) completed the survey (November 2021 to January 2022, 72% female, mean 21 years post-terminal degree). Most PIs were aware of translational models and believed preliminary studies should precede larger trials but also believed a single preliminary study provided sufficient evidence to scale. When asked about the relative importance of preliminary efficacy (i.e. changes in outcomes) and feasibility (i.e. recruitment, acceptance/adherence) responses varied. Preliminary studies were perceived as necessary to successfully compete for research funding, but among PIs who had peer-reviewed federal-level grants applications (n = 343 [80%]), responses varied about what should be presented to secure funding. Confusion surrounding the definition of a successful, informative preliminary study poses a significant challenge when developing behavior interventions. This may be due to a mismatch between expectations surrounding preliminary studies and the realities of the research enterprise in which they are conducted. To improve the quality of preliminary studies and advance the field of behavioral interventions, additional funding opportunities, more transparent criteria in grant reviews, and additional training for grant reviewers are suggested.
... We tested our objectives using a robust singlesample pilot study (Onken et al., 2014). Participants completed an online battery of selfreport measures described below before (T1), immediately after (T2), and 2 months after (T3) the 6-week intervention. ...
... Despite these limitations in design, the current study represents a robust single-sample pilot study providing initial support of a novel intervention for reducing internalized ageism. Given the strong results from the current study, a future blinded randomized controlled trial is warranted to establish the efficacy of the trial (Onken et al., 2014). This research should also include more points of measurement to establish causal mediation, as well as a longer follow-up period. ...
... Arguably, this has been sustained by insufficient implementation of new techniques, based on evidence from recent clinical RCTs [9,10]. During the past decades, research in AUD has highlighted the role of automatically activated processes in the development and maintenance of AUD [11] as well as in the maintenance of abstinence after treatment [12]. ...
... Following the results of previous studies, we preregistered to expect higher success rates for patients after TAU + ApBM than after TAU-only. Further, we explored the acceptance of ApBM by patients and therapists because novel treatments are often accepted as part of research projects but less so in daily practice when they require additional resources from therapists and patients [8,9,10]. ...
b> Introduction: Abstinence rates after inpatient treatment for alcohol use disorder (AUD) are modest (1-year rate around 50%). One promising approach is to re-train the automatically activated action tendency to approach alcohol-related stimuli (alcohol-approach bias) in AUD patients, as add-on to regular treatment. As efficacy has been demonstrated in well-controlled randomized controlled trials, the important next step is to add alcohol-approach-bias modification (alcohol-ApBM) to varieties of existing treatments for AUD. Therefore, this prospective, multicenter implementation-RCT examined whether adding alcohol-ApBM to regular treatments (various abstinence-oriented treatments including both individual and group-based interventions) would significantly increase abstinence rates compared to receiving regular treatment only, in a variety of naturalistic settings with different therapeutic approaches. Methods: A total of 1,586 AUD inpatients from 9 German rehabilitation clinics were randomly assigned to receive either ApBM in addition to regular treatment or not. Training satisfaction of patients and therapists was measured after training. Success rates were determined at 3, 6, and 12 months post-treatment. Results: Return rates of the post-treatment assessments varied greatly between clinics, often being low (18–76%). Nevertheless, ApBM significantly increased success rates after 3 months. After 6 and 12 months, the differences were not significant. ApBM was evaluated mostly positively by patients and therapists. Discussion/Conclusion: ApBM was an effective add-on to regular treatment of AUD at 3 months follow-up, across a variety of AUD treatment settings. However, low return rates for the clinical outcomes reduced the effect size of ApBM considerably. The application of ApBM proved feasible in varying clinical settings, offering the opportunity to modify automatic processes and to promote abstinence.
... The app received a relatively high overall quality rating, especially concerning its functionality. Pending future research, these encouraging preliminary stage I results indicate a promising foundation for future progress according to the National Institutes of Health stage model for behavioral intervention development [49]. ...
... The promising preliminary results indicate a strong foundation for programmatic developments according to the National Institutes of Health stage model [49]. The intervention will benefit from larger well-powered RCTs in a more diverse population. ...
Background
Frailty, a common geriatric syndrome, predisposes older adults to functional decline. No medications can alter frailty's trajectory, but nutritional interventions may aid in supporting independence.
Objective
This paper presents a pilot randomized controlled trial to investigate the feasibility and efficacy of a mobile health intervention, “Olitor,” designed to enhance adherence to the Mediterranean diet among older adults with frailty, requiring no external assistance.
Methods
The study sample consisted of 15 participants aged 66-77 (mean 70.5, SD 3.96) years randomized into intervention (n=8; 8 females; mean 72.4, SD 4.8 years) and control groups (n=7; 6 females, 1 male; mean 70.0, SD 3.9 years). The intervention involved a patient-facing mobile app called “Olitor” and a secure web-based administrative dashboard. Participants were instructed to use the app at least weekly for 3 months, which provided feedback on their food choices, personalized recipe recommendations, and an in-app messaging feature. Using Mann-Whitney tests to compare change scores and Hedges g statistics to estimate effect sizes, the primary efficacy outcomes were adherence to the Mediterranean diet score and insulin resistance measures. Secondary outcomes included retention as a measure of feasibility, engagement level and user app quality ratings for acceptability, and additional metrics to evaluate efficacy. Models were adjusted for multiple comparisons.
Results
The findings demonstrated a significant improvement in the Mediterranean diet adherence score in the intervention group compared to the control (W=50.5; adjusted P=.04) with median change scores of 2 (IQR 2-4.25) and 0 (IQR –0.50 to 0.50), respectively. There was a small and insignificant reduction in homeostasis model assessment of insulin resistance measure (W=23; adjusted P=.85). Additionally, there were significant increases in legume intake (W=54; adjusted P<.01). The intervention's effect size was large for several outcomes, such as Mediterranean diet adherence (Hedges g=1.58; 95% CI 0.34-2.67) and vegetable intake (Hedges g=1.14; 95% CI 0.08-2.21). The retention rate was 100%. The app's overall quality rating was favorable with an average interaction time of 12 minutes weekly.
Conclusions
This pilot study revealed the potential of the mobile intervention “Olitor” in promoting healthier eating habits among older adults with frailty. It demonstrated high retention rates, significant improvement in adherence to the Mediterranean diet, and increased intake of recommended foods. Insulin resistance showed a minor nonsignificant improvement. Several secondary outcomes, such as lower extremity function and Mediterranean diet knowledge, had a large effect size. Although the app's behavior change features were similar to those of previous digital interventions, the distinctive focus on theory-informed mechanistic measures involved in behavioral change, such as self-regulation, self-efficacy, and expected negative outcomes, may have enhanced its potential. Further investigations in a more diverse and representative population, focusing on individuals with impaired insulin sensitivity, are warranted to validate these preliminary findings.
Trial Registration
ClinicalTrials.gov NCT05236712; https://clinicaltrials.gov/study/NCT05236712
... The current study's primary aim was to further develop our brief telehealth BPT and explore the feasibility and acceptability of our intervention and research methods. Guided by the NIH Stage Model for Behavioral Interventions (Onken et al., 2014), we conducted a Stage 1 pilot study. In the NIH Stage Model, Stage 1 pilot studies are designed to "develop, modify, refine, adapt, and pilot test behavioral treatment interventions" (Onken et al., 2014, pp. ...
Behavioral parent trainings (BPTs) are highly efficacious manualized treatments for young children with disruptive behaviors. However, access and engagement can be challenging for most families that would benefit from treatment, thereby limiting the impact BPTs have on population health. Brief telehealth versions of traditional BPTs present a promising but understudied alternative to traditional in-person interventions and may ease the burden of participation for families. This study reports on a mixed-methods feasibility trial of a brief telehealth BPT delivered within a pediatric primary care practice. Twenty-seven families with children between ages 3–8 enrolled in the 4-session telehealth intervention. Caregivers and clinicians provided quantitative and qualitative data describing the feasibility and acceptability of the program. Data across informants suggested that the brief telehealth program was feasible to implement and acceptable to stakeholders, with a few important caveats. For clinicians, logistical support was key to engagement. Caregivers identified both facilitators of and barriers to engagement unique to the brief telehealth model. Caregivers and clinicians reported that positive parenting strategies were easier to teach and learn compared to disciplinary strategies, particularly time-out. We also found that despite improved flexibility of telehealth, attrition rates were still high and similar to rates observed in traditional delivery models. Brief telehealth programs hold the potential to expand the reach of evidence-based parenting interventions. However, these programs do not fully address barriers to care, and future interventions should be designed with the strengths and limitations of telehealth in mind.
... Results from this BA pilot trial will directly inform the design of a more rigorous RCT. The sequential progression from pilot study to efficacy trial is aligned with established frameworks for development and testing of behavioral interventions (Craig et al., 2008;Czajkowski et al., 2015;Onken et al., 2014). The present study had the following specific aims: (1) Investigate feasibility of BA-A participation for autistic youth, (2) Investigate feasibility of BA-A implementation for therapists, (3) Examine preliminary efficacy of BA-A for depression symptoms in youth with autism, and (4) Examine preliminary efficacy of BA-A on secondary outcomes of anxiety and social skills in youth on the autism spectrum. ...
... Although singlecase studies are viewed with suspicion and regarded as "non-experimental" due to the RCT's domination (Roitberg, 2012). Clinical case studies are one of the most valuable contributions of this type of method in the clinical field for a detailed study of behaviors in controlled situations, which makes it possible to isolate and investigate the factors that affect the dependent variable, obtaining qualitative or quantitative data on the effect (Kazdin, 1992;Onken et al., 2014). ...
The current study tests the effects of a brief intervention program based on the contextual therapies (Acceptance
and Commitment Therapy and Functional Analytic Psychotherapy) to enhance the well-being and interpersonal
relationships in the workplace. This research represents a unified model (FACT) based on functional contextualism.
As pilot study, we present the application with two workers with relational and emotional problems
between them. We use a single-case design measuring pre, post and follow-up after six months. The assessment
was made with various questionnaires and direct measurement of clinically relevant behaviors. The total
intervention was carried out individually for a month and a half. The results revealed improvements in both
employees about their personal and professional relationships, and also appearing generalisation with improvements
in other areas (intimacy, personal relationships, family, friends). The study has implications by
highlighting the importance of behavioral analysis or problems in work relationships, and by showing that the
integration of contextual therapies can produce rapid results in non-clinical situations. Lastly, the in-depth
insight into the change processes triggered by the interventions with FACT as a way to include this approach
based on evidence philosophy applied in the workplace.
... smoking cessation, falls prevention) were included with phase III studies because they were not being evaluated for safety (phase I), efficacy (phase II), or at the surveillance stage (phase IV) but rather evaluating intervention effectiveness, analogous to phase III. This classification strategy is comparable to that of other work focusing on behavioural interventions [17,18]. Studies that were recruiting into more than one trial were coded as 'multiple trials/phases' . ...
Background
Recruiting participants to clinical trials is an ongoing challenge, and relatively little is known about what recruitment strategies lead to better recruitment. Recruitment interventions can be considered complex interventions, often involving multiple components, targeting a variety of groups, and tailoring to different groups. We used the Template for Intervention Description and Replication (TIDieR) reporting checklist (which comprises 12 items recommended for reporting complex interventions) to guide the assessment of how recruitment interventions are described. We aimed to (1) examine to what extent we could identify information about each TIDieR item within recruitment intervention studies, and (2) observe additional detail for each item to describe useful variation among these studies.
Methods
We identified randomized, nested recruitment intervention studies providing recruitment or willingness to participate rates from two sources: a Cochrane review of trials evaluating strategies to improve recruitment to randomized trials, and the Online Resource for Research in Clinical triAls database. First, we assessed to what extent authors reported information about each TIDieR item. Second, we developed descriptive categorical variables for 7 TIDieR items and extracting relevant quotes for the other 5 items.
Results
We assessed 122 recruitment intervention studies. We were able to extract information relevant to most TIDieR items (e.g., brief rationale, materials, procedure) with the exception of a few items that were only rarely reported (e.g., tailoring, modifications, planned/actual fidelity). The descriptive variables provided a useful overview of study characteristics, with most studies using various forms of informational interventions (55%) delivered at a single time point (90%), often by a member of the research team (59%) in a clinical care setting (41%).
Conclusions
Our TIDieR-based variables provide a useful description of the core elements of complex trial recruitment interventions. Recruitment intervention studies report core elements of complex interventions variably; some process elements (e.g., mode of delivery, location) are almost always described, while others (e.g., duration, fidelity) are reported infrequently, with little indication of a reason for their absence. Future research should explore whether these TIDieR-based variables can form the basis of an approach to better reporting of elements of successful recruitment interventions.
... nih. gov/ behav iorch ange) and the NIH stage model (Onken et al., 2014). On the practical level, comparative studies in real-world contexts are needed to help with D&I of SDM and to gain understanding of its application in particular contexts. ...
Despite considerable progress in recent years, research in cardiac psychology is not widely translated into routine practice by clinical cardiologists or clinical health psychologists. Self-determination theory (SDT), which addresses how basic psychological needs of autonomy, competence, and relatedness contribute to the internalization of motivation, may help bridge this research–practice gap through its application to shared decision-making (SDM). This narrative review discusses the following: (a) brief background information on SDT and SDM, (b) the application of SDT to health behavior change and cardiology interventions, and (c) how SDT and SDM may be merged using a dissemination and implementation (D&I) framework. We address barriers to implementing SDM in cardiology, how SDM and SDT address the need for respect of patient autonomy, and how SDT can enhance D&I of SDM interventions through its focus on autonomy, competence, and relatedness and its consideration of other constructs that facilitate the internalization of motivation.
... In terms of the stage model of intervention development, we position this trial's approach at "Stage III"; in that we tested the two programs in a real-world setting, using an implementable format, while applying an RCT design to establish internal validity (Bartlett et al., 2019;Onken et al., 2014). Establishing these programs' utility for reducing stress reactivity under these conditions is considered a particularly important step, which should occur prior to recommending the same training approaches to work psychology practitioners and organizational stakeholders (i.e., Stage IV and V research initiatives). ...
Mindfulness interventions have become a common feature of worksite stress management provision. However, the evidence underpinning these interventions continues to attract scrutiny, with unresolved questions surrounding: the generalizability of mindfulness research findings to real-world workplace training applications, comparability of different mindfulness approaches offered in workplace settings, and effects on job performance. The current trial contributes to the literature by exploring effects of mindfulness training (MT) and acceptance and commitment therapy (ACT), which were delivered to staff in the same healthcare organization. Participants were randomly assigned to a 4-session MT program (n = 63), a 4-session ACT program (n = 67), or a waiting list control group (n = 69). Study measures were administered on five occasions spread across a 6-month period. Results indicated that both MT and ACT reduced perceived stress and improved mindfulness and sleep quality when compared to the control group. ACT showed slight superiority in helping employees align their behaviour with personal values. Neither MT nor ACT was effective in reducing work limitations. We consider explanations for equivocal effects on job performance outcomes, and highlight the importance of testing the effectiveness of worksite mindfulness interventions under ecologically valid conditions. ARTICLE HISTORY
... This predicament appears with other models for other psychological struggles, of course. Multiple authors have emphasized problematic rates of adoption of empirically-supported treatments since before IFS became popular (Lilienfeld et al., 2013;Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014). Nevertheless, IFS's popularity in PAT makes focusing on the model particularly relevant. ...
Though several treatments effectively address the pervasive impact of trauma, they do not achieve complete symptom resolution for all clients, inspiring the search for alternatives. Internal Family Systems (IFS) therapy has grown popular, especially in informal psychedelic-assisted treatments (PAT). Compared to stereotypes of empirically validated, exposure-based treatments, IFS has novel facets with widespread appeal. The model encourages improved quality of interactions among multiple, naturally arising “parts” or subpersonalities potentially generated by traumatic experience. The body of IFS literature is extensive, enthusiastic, and thought-provoking. Outcome data for applying the model to Post-Traumatic Stress Disorder are limited. Attempts to operationalize and falsify the theory's assumptions and proposed mechanisms will likely prove challenging. Nevertheless, the model's popularity underscores a problem with perceptions of the empirically-supported treatments. Contemplating ethical ways to present the IFS approach given the state of relevant research, we note strategies that would apply to recommendations for PAT of any type. These strategies include detailed psychoeducation about empirically-supported treatments, candid description of the experimental nature of alternatives, frequent assessments of improvement, and detailed monitoring of potential iatrogenic effects. Drawing on facets of IFS to improve perceptions of the empirically validated treatments might provide an efficient way to appeal to more clients, decrease drop out, and increase gains as we await results of empirical investigations of IFS-influenced PAT. These steps can allow clients to choose an approach consistent with their own impressions of a credible intervention, potentially leading to better outcomes.
... We are at the early stages of testing the benefits and mechanisms of CFM™-D and more rigorous efficacy testing is needed to establish the intervention's potential in the United States. Nonetheless, scalability of CFM™-D is a particularly important issue to consider even in the Stage I phase of evaluation (per the NIH Stage Model; Onken et al., 2014). In our current pilot, two doctoral-prepared interventionists delivered the content of the intervention. ...
Background and Objectives: Driving retirement can be a necessary but challenging and emotionally complex transition, especially for people living with dementia. This pilot study evaluated the utility of CarFreeMe™-Dementia (CFM™-D), a telehealth intervention providing tailored education and social support to those living with dementia and their care partners, as they prepare for or adjust to driving retirement. Delivered by empathetic health professionals, CFM™-D is a person-centric, flexible program tailored to address challenges specific to the participants' driving retirement stage and individualized contexts.
... The aim of the present study was to evaluate the feasibility, acceptability, and clinical effects of a brief, online MBI (i.e., Mini MORE) designed to promote TJA patients' postoperative pain self-management during the subacute phase. We planned to accomplish two aims in this stage 1 randomized controlled trial (RCT), i.e., a small scale trial focused on the feasibility and pilot testing of a new intervention (Onken et al., 2014): (1) assess the feasibility and acceptability of an asynchronous, video-recorded version of Mini MORE for pain self-management in the subacute phase following TJA; and (2) examine the preliminary effects of Mini MORE on pain intensity, pain-related functional interference, and pain medication use (i.e., clinical outcomes), as well as pain acceptance, pain catastrophizing and mindfulness (i.e., therapeutic mechanisms) relative to an active control condition involving video-recorded pain coping education. Regarding feasibility and acceptability, we set the following benchmarks (National Center for Complementary and Integrative Health, 2023;Teresi et al., 2022): at least 80% of participants in the experimental group will complete the 4 weekly sessions as well as the post-treatment assessment. ...
Objectives
Recent brief mindfulness-based interventions (MBI) provided before surgery have shown promising results in improving clinical outcomes in patients undergoing total joint arthroplasty (TJA). However, they have not been delivered in the subacute phase after surgery to target patients at risk for chronic postsurgical pain (CPSP). The use of technologies allowing remote and online delivery can help increase the accessibility of these interventions.
Method
We conducted a single site, two-arm pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary effects of online Mini More (i.e., a condensed, 4-week mindfulness-based program) promoting pain self-management during the subacute postoperative phase. We randomized 36 patients into two groups (Mini MORE, n = 18 and Pain Coping Education, n = 18). Postoperative outcomes were: pain intensity, pain interference, analgesic medication use, pain catastrophizing, pain acceptance and mindfulness.
Results
Results indicated that Mini MORE was highly feasible and well received. Further, results indicated that pain intensity (d = 1.47, p < 0.001) as well as pain interference levels (d = 1.04, p = 0.005) and medication use (Cliff’s Delta=-0.56, p = 0.02) were significantly different between groups after treatment. Statistically significant group by time interactions were found for both pain intensity (p < 0.001) and pain interference (p = 0.003), and a trend toward a decrease in pain medication use (p = 0.05) was observed in favor of the Mini MORE group. No statistically significant differences were found between groups for pain acceptance (d = -0.58), pain catastrophizing (d = 0.01) and mindfulness (d = -0.23).
Conclusions
Our results suggest Mini MORE is a feasible and acceptable brief, online MBI potentially capable of decreasing pain intensity and pain interference in the subacute period after TJA, thus Mini MORE may be a promising tool for preventing CPSP.
Preregistration
NCT04848428
... In general, research focused on interventions for disgust-related disorders can be informed by the stage model of behavioral intervention development, which is composed of six stages (Onken et al., 2014): basic science (Stage 0); intervention generation, refinement, modification, and adaptation and pilot testing (Stage I); traditional efficacy testing (Stage II); efficacy testing with real-world providers (Stage III); effectiveness research (Stage IV); and dissemination and implementation research (Stage V). There is now good evidence on how basic research on disgust can directly inform intervention generation. ...
Anxiety disorders have long been conceptualized as disorders of fear, while other emotions have largely been overlooked. However, an emerging literature has increasingly implicated disgust in certain anxiety-related disorders, including obsessive-compulsive disorder, specific phobias (e.g., spider phobia), health anxiety, and post-traumatic stress disorder. Roughly two decades of research has accumulated evidence identifying various mechanisms linking disgust-related phenomena to these disorders. In the present “State of the Science” review, we sought to summarize the current state of the literature with respect to disgust-related mechanisms in anxiety disorders, including trait-level vulnerabilities (e.g., disgust proneness), cognitive processes (e.g., biases of attention and memory), and associated learning mechanisms (e.g., evaluative conditioning). Research in these areas has revealed important ways in which disgust differs from fear-related phenomena, which have important treatment implications. From there, we sought to summarize research on laboratory interventions that attempt to target and attenuate disgust, as well as the early research on formal cognitive-behavioral treatments that integrate disgust-related interventions for anxiety disorders. Although the past two decades of research have revealed important insights related to the role of disgust in psychopathology, much remains to be learned in this area. We propose some future directions, emphasizing the importance of a guiding framework that highlights studying disgust-related mechanisms across different levels of analysis.
... This sample size is guided by NIH Stage Model for Intervention Development guidelines of including 15-30 participants per interviewee group. [83] Interview questions will be on advantages of participating in BETTER, what participants valued or perceived to be most helpful, as well as concerns, challenges, and disadvantages of participating in BETTER. The interview guide will be available in English and Spanish and will be piloted before use. ...
Objective
The purpose of this study is to examine the efficacy of BETTER ( B rain Injury, E ducation, T raining, and T herapy to E nhance R ecovery) vs. usual transitional care management among diverse adults with traumatic brain injury (TBI) discharged home from acute hospital care and families.
Methods
This will be a single-site, two-arm, randomized controlled trial (N = 436 people, 218 patient/family dyads, 109 dyads per arm) of BETTER, a culturally- and linguistically-tailored, patient- and family-centered, TBI transitional care intervention for adult patients with TBI and families. Skilled clinical interventionists will follow a manualized protocol to address patient/family needs. The interventionists will co-establish goals with participants; coordinate post-hospital care, services, and resources; and provide patient/family education and training on self- and family-management and coping skills for 16 weeks following hospital discharge. English- and Spanish-speaking adult patients with mild-to-severe TBI who are discharged directly home from the hospital without inpatient rehabilitation or transfer to other settings (community discharge) and associated family caregivers are eligible and will be randomized to treatment or usual transitional care management. We will use intention-to-treat analysis to determine if patients receiving BETTER have a higher quality of life (primary outcome, SF-36) at 16-weeks post-hospital discharge than those receiving usual transitional care management. We will conduct a descriptive, qualitative study with 45 dyads randomized to BETTER, using semi-structured interviews, to capture perspectives on barriers and facilitators to participation. Data will be analyzed using conventional content analysis. Finally, we will conduct a cost/budget impact analysis, evaluating differences in intervention costs and healthcare costs by arm.
Discussion
Findings will guide our team in designing a future, multi-site trial to disseminate and implement BETTER into clinical practice to enhance the standard of care for adults with TBI and families. The new knowledge generated will drive advancements in health equity among diverse adults with TBI and families.
Trial registration
NCT05929833 .
... consistently, we had participants test and provide feedback on several prototypes of Mindful Journey. Our development approach was also informed by the stage model of intervention development [62], which prioritizes intervention refinement, modification, and pilot testing before efficacy testing. We prioritized obtaining in-depth nuanced feedback from a small set of participants so we could refine Mindful Journey. ...
Background/Objectives
There is a great unmet need for accessible adjunctive interventions to promote long-term recovery from substance use disorder (SUD). This study aimed to iteratively develop and test the initial feasibility and acceptability of Mindful Journey, a novel digital mindfulness-based intervention for promoting recovery among individuals with SUD.
Patients/Materials
Ten adults receiving outpatient treatment for SUD.
Methods
Phase 1 (n = 5) involved developing and testing a single introductory digital lesson. Phase 2 included a separate sample (n = 5) and involved testing all 15 digital lessons (each 30- to 45-minutes) over a 6-week period, while also receiving weekly brief phone coaching for motivational/technical support.
Results
Across both phases, quantitative ratings (rated on a 5-point scale) were all at or above a 4 (corresponding with ‘agree’) for key acceptability dimensions, such as usability, understandability, appeal of visual content, how engaging the content was, and helpfulness for recovery. Additionally, in both phases, qualitative feedback indicated that participants particularly appreciated the BOAT (Breath, Observe, Accept, Take a Moment) tool for breaking down mindfulness into steps. Qualitative feedback was used to iteratively refine the intervention. For example, based on feedback, we added a second core mindfulness tool, the SOAK (Stop, Observe, Appreciate, Keep Curious), and we added more example clients and group therapy videos. In Phase 2, 4 out of 5 participants completed all 15 lessons, providing initial evidence of feasibility. Participants reported that the phone coaching motivated them to use the app. The final version of Mindful Journey was a smartphone app with additional features, including brief on-the-go audio exercises and a library of mindfulness practices. Although, participants used these additional features infrequently.
Conclusions
Based on promising initial findings, future acceptability and feasibility testing in a larger sample is warranted. Future versions might include push notifications to facilitate engagement in the additional app features.
... Therefore, updating the questionnaire is justified in order to enhance its validity and applicability. Incorporating research findings from the field to modify our way of representing, theorizing, or fundamentally conceptualizing emotion regulation in a virtuous cycle could be achieved by drawing on existing models in intervention sciences [73]. Based on current evidence, emotion regulation strategies as assessed through the CERQ do not appear to be efficacious targets for intervention with the aim of diminishing anxiety levels, facilitating the adoption of functional behaviors in adolescents, or enhancing academic performance. ...
Trait anxiety, emotion regulation strategies, and metacognitive beliefs influence executive functions (EFs) and academic achievement. This study examines their interplay and impact on academic success. In total, 275 adolescents (10–17 years) and parents completed an online questionnaire assessing trait anxiety, emotion regulation strategies, metacognition, parent-reported behaviors related to executive functioning, and overall school average. Preliminary analyses confirmed consistency with the existing literature for each variable and their interaction. Furthermore, we conducted a network analysis among the main variables. This analysis supports the need to pay more attention to reflective variables—maladaptive emotion regulation strategies and metacognitive beliefs about worry—when studying trait anxiety. These variables were linked to problematic executive functioning in adolescents, and the latter was negatively linked to academic achievement. This study offers innovative insights by investigating relationships less explored in the scientific literature. It reveals high and significant correlations between metacognitive beliefs, maladaptive emotion regulation strategies, and trait anxiety (r > 0.500, p < 0.001) but also between these variables and both executive functioning and academic achievement. These findings offer new perspectives for research and underscore the importance of holistically examining the psychological factors related to academic success.
... Given this aim, the corollary and exploratory goal was to understand which ones of the preferred linguistic variations in messages might have an impact on how motivating older adults perceive a message to be (Aim 2). The study serves as a pilot for the feasibility of a component of a larger intervention (i.e., stage 1b of the NIH stage model for behavioral intervention development; Onken et al., 2014). To inform the tailoring effort, a prior study was conducted to understand older adults' reason to participate in research studies. ...
This study examined the feasibility of using tailored text messages to promote adherence to longitudinal protocols and determined what facets of text message tone influence motivation. Forty-three older adults ( M age = 73.21, SD = 5.37) were recruited to engage in video-game-based cognitive training for 10 consecutive days. Participants received encouraging text messages each morning that matched their highest or lowest ranking reasons for participating in the study, after which they rated how effective each message was in motivating them to play the games that day. After 10 days, participants rated all possible messages and participated in semi-structured interviews to elicit their preferences for these messages. Results showed that messages matching participants’ reasons for participating were more motivating than mismatched messages. Further, participants preferred messages that were personalized (i.e., use second person voice) and in formal tones. Messages consistent with these preferences were also rated as more motivating. These findings establish the feasibility of using message tailoring to promote adherence to longitudinal protocols and the relevance of tailoring messages to be personal and formal.
... An emphasis on research among racial minority groups is a potential strength of projects in R/S and health as it might reflect heightened efforts to address health disparities, but the greater focus on observational studies at the expense of interventional research likely undermines progress. Indeed, existing translational frameworks (Czajkowski et al., 2015;Onken et al., 2014) highlight the key role intervention development and testing serve for increasing the potential for high-impact prevention and treatment science research. ...
Religion and spirituality (R/S) have been linked to better physical and mental health. The US government has funded several research studies that include a focus on R/S but the amount of support over the last several years appears to be declining. To better understand these funding trends for R/S and health research, we chose relevant comparisons from projects that include a focus on social support and optimism. We identified total amount of funding, change in funding patterns over time, and characteristics of funded projects from a large database of US research projects (Federal RePORTER). We reviewed 5093 projects for social support and 6030 projects for optimism before narrowing the number of eligible studies to 170 and 13, respectively. Social support projects received the largest investment of $205 million dollars. Funded awards for social support and optimism remained stable over time while R/S decreased (p = 0.01), intervention research was more characteristic and studies of African-American/Black participants were less characteristic of funded projects in social support than of R/S (ps < 0.001). Future research for R/S and health would likely benefit from continued focus on minority communities and on identifying and developing appropriate interventions to support individual and community health and well-being.
... Therefore, updating the questionnaire is justified in order to enhance its validity and applicability. Incorporating research findings from the field to modify our way of representing, theorizing, or fundamentally conceptualizing emotion regulation in a virtuous cycle could be done by drawing on existing models in intervention sciences [71]. Based on current evidence, emotion regulation strategies as assessed through the CERQ do not appear to be efficacious targets for intervention with the aim of diminishing anxiety levels, facilitating the adoption of functional behaviors in adolescents, or enhancing academic performance. ...
Trait anxiety, emotion regulation strategies, and metacognitive beliefs influence executive functions (EF) and academic achievement. This study examines their interplay and impact on academic success. In total, 275 adolescents (10-17 years) and parents completed an online questionnaire assessing trait anxiety, emotion regulation strategies, metacognition, parent-reported behaviors related to executive functioning, and overall school average. Preliminary analyses confirmed consistency with existing literature for each variable and their interaction. Furthermore, we conducted a network analysis among the main variables. This analysis supports the need to pay more attention to reflective variables - maladaptive emotion regulation strategies and metacognitive beliefs about worry - when studying trait anxiety. These variables were linked to problematic executive functioning in adolescents. These latter had a negative link to academic achievement. This study offers innovative insights by investigating less-explored relationships in the scientific literature. It reveals high and significant correlations between metacognitive beliefs, maladaptive emotion regulation strategies and trait anxiety (r > .500, p < .001) but also between these variables and both executive functioning and academic achievement. These findings offer new perspectives for research and underscore the importance of holistically examining psychological factors related to academic success.
... If mechanisms of an intervention's benefit are unclear, attempts to translate the intervention for dissemination and implementation in broader clinical, community, and cultural contexts becomes more difficult. [30][31][32] Capturing Participant Voices Many dementia care interventions are tailored to the needs of participants, but existing, validated quantitative measures (eg, burden, depressive symptoms) may not capture the full experiences nor expectations of intervention recipients. 33 Among dementia care interventions that collect qualitative data during or following quantitative data collection, a disconnect is sometimes apparent: inconsistent statistical or clinical differences are found using empirical outcome measures while anecdotal data indicate that participants perceive considerable utility and benefit. ...
This study sought to determine the perceived benefits of the Residential Care Transition Module (RCTM), a novel multi-component, psychoeducational/psychosocial, telehealth intervention for caregivers of cognitively impaired relatives living in residential long-term care (RLTC). Few support programs exist for these caregivers. Determining the intervention’s mechanisms of benefit will provide actionable clinical and research information regarding which key features aspects RLTC and public health agencies should offer their families. We conducted semi-structured interviews with 30 purposively selected participants randomly assigned to receive the RCTM. Additionally, an open-ended survey question solicited feedback at 4 (n = 90), 8 (n = 79), and 12 months (n = 77). Available qualitative data were analyzed for thematic content. Participants endorsed 9 mechanisms of benefit. Six mechanisms were related to RCTM content: education dementia progression and dementia behavior management, personalized resource provision, strategies for communication and engagement with the care recipient (CR) and others, management of multiple roles, and relaxation exercises. Three mechanisms were related to coaching: emotional support, knowledgeability, and being a neutral third party. Common benefits attributed to RCTM included improvement in mood, caregiving confidence, and communication and interactions with CR and others. Using qualitative data and analyses, we discovered the most valued aspects of the RCTM intervention. These mechanisms of benefit have not been described in the literature. Notably, we were unable to detect mechanisms of benefit in a separate analysis utilizing quantitative data. Findings emphasize the importance of including qualitative measures in intervention research and selecting quantitative measures that reflect the intervention’s real effects, if any.
... 605). They also asserted additional work at the basic science level (Stage 0) could illuminate questions concerning mechanisms of change (Onken et al., 2014). Crane et al. (2017) claimed that a "critical underpinning issue" throughout the NIH Stage model is the "fidelity/integrity of the [mindfulness based] intervention itself" citing the "need to re-clarify the core ingredients" for the purpose of research and professional development (p. ...
Meta-analyses and reviews have explored school-based mindfulness program (SBMP) outcomes, but the contents of the written curricula remain unexamined. The purpose of this study was to identify and categorize the mindfulness practices and skills as evidenced in the written curricula of twelve accessible SBMPs. Three coders divided each curriculum into curricular elements (CEs) and coded each element for instructional mode and, where applicable, mindfulness practice and skill. Descriptive analyses were conducted on codes to ascertain the frequency of mindful skills and practices across all SBMPs and differences between elementary and secondary school curricula. Of the 2643 CEs identified across curricula, 50.1% were coded as a mindfulness practice. Twenty distinct mindfulness practices were coded within six practice-type categories. The Somatic category included the most distinct practices and represented the majority (67.6%) of mindfulness practices taught. Over 73% of CEs were coded as fostering a mindfulness skill. Intrapersonal skills were most often cultivated across SBMPs with focused attention being most prevalent. Results suggest there may be a reliance on more straightforward practices and skills that do not require the teachers’ or students’ grasp of the complex nuances of mindfulness. Developmental differences show more prevalence of interpersonal skills for elementary students than secondary. This analysis of core curricular content of SBMPs provides foundational knowledge necessary for refining research at all stages of the NIH Stage model, from theory generation and refinement based on children’s developmental needs to identification of active ingredients most likely to impact intervention outcomes.
... Project CHROMA (Cognitive Health Research on Musical Arts) is a Stage 1 clinical trial designed to test the effects of a music creativity intervention on various psychological and biological outcomes in adults with MCI or at higher risk of MCI (i.e., 70 years and older). Stage 1 of the National Institute of Health Stage Model involves developing new/modifying existing interventions (Stage 1a) and feasibility and pilot testing (Stage 1b) (Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014). In contrast to most music interventions that primarily involve passive music listening, the music creativity intervention within Project CHROMA incorporates both music listening and music composition and improvisation; from the first day of class, participants are taught to interact and produce creative pieces with everyday objects and sounds. ...
Objectives
Hundreds of trials have evaluated Mindfulness-Based Stress Reduction (MBSR), but in the United States, it is generally not covered by health insurance. Consequently, the aims were to identify the following: (1) key questions to make decisions about if, how, and when MBSR should be covered by health insurance; (2a) barriers and (2b) facilitators to understand and resolve for MBSR to be covered by health insurance; and (3) highest priority evidence needed to inform health insurance coverage decisions.
Methods
Key informants (n = 26) included health insurers, healthcare administrators, policymakers, clinicians, MBSR instructors, and MBSR students. An initial pool of items related to the study aims was generated through qualitative interviews. Through the Delphi process, participants rated, discussed, and re-rated each item’s relevance. Items were required to reach a consensus of ≥ 80% agreement to be retained for final inclusion.
Results
Of the original 149 items, 42 (28.2%) met the ≥ 80% agreement criterion and were retained for final inclusion. The most highly rated items informing whether MBSR should be covered by health insurance included research demonstrating that MBSR works and that it is not harmful. The most highly rated barriers to coverage were that MBSR is not a medical treatment and patient barriers to attendance. Highly rated facilitators included the potential of MBSR to address common mental health and psychosomatic problems. Finally, understanding what conditions are effectively treated with MBSR and the impact of MBSR on stress were rated as the highest priority evidence needed to inform health insurance coverage decisions.
Conclusions
Findings highlight priorities for future research and policy efforts to advance health insurance coverage of MBSR in the United States.
Background and Objectives
Respite, defined as time away from caregiving, is the most requested type of caregiver support. Time for Living and Caring (TLC) is a virtual coaching "app" that helps caregivers schedule and plan their respite time-use. The objectives of this analysis are: 1) to assess the efficacy of the TLC intervention on respite time-use and on caregiver well-being, and 2) to identify the key features of the intervention that serve as the likely mechanism of action.
Research Design and Methods
A sample of dementia caregivers (n=163, 79% female, 84% White, 6% Hispanic, average age 62) were randomized into one of two intervention delivery methods. Intervention efficacy was evaluated using pre/post comparisons of respite time-use and an additive “dosing” model that estimated unique parameters associated with the exposure to each specific intervention component.
Results
Both immediate and delayed-attention groups reported increased respite time. They also improved in their ability to plan and perceive benefit from their respite time-use over the 16-week intervention period. At 8 weeks, the immediate group did not change in anxiety while the delayed group worsened (p < 0.001). At 16 weeks, the groups were similar in their anxiety levels. By the 20-week follow-up period, when neither group had access to TLC, both experienced an increase in anxiety.
Discussion and Implications
TLC is a promising intervention that may support caregivers’ well-being, by helping them schedule and plan their respite to maximize its benefit. The provision of weekly coaching seems to be the intervention component (mechanism) associated with caregiver outcomes.
Background
In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences.
Methods
To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of a well-known PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences.
Results
A total of 496 authors were invited to take part in the three-round Delphi survey (round 1, N = 46; round 2, N = 24; round 3, N = 22). A set of twenty considerations, broadly categorized into six themes (intervention design, study design, conduct of trial, implementation of intervention, statistical analysis, and reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading.
Conclusion
We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.
Background: Adults with advanced cancer experience profound future uncertainty, reflected in elevated fear of cancer progression (FoP) and cancer-related trauma symptoms. These symptoms are associated with physical symptom burden and poorer quality of life, and few interventions exist to manage them. Objective: To develop and pilot a written exposure-based coping intervention (EASE) focused on worst-case scenarios among adults with advanced cancer reporting elevated cancer-related trauma symptoms or FoP. Design: A single-arm intervention development and pilot trial. Participants: The trial enrolled 29 U.S. adults with stage III or stage IV solid tumor cancer (n = 24) or incurable or higher-risk blood cancer (n = 5) reporting elevated cancer-related trauma symptoms or FoP. Among those screened, 74% were eligible, with an eligible-to-enrolled rate of 85%. Design/Measurements: EASE was delivered over five 1:1 videoconferencing sessions. Feasibility and acceptability were evaluated via attendance, surveys, and exit interviews. Outcomes were assessed at five time points through 3-month (FU1, main assessment of interest) and 4.5-month (FU2) follow-up. Results: Participant and interventionist feedback was used to iteratively refine EASE. Among participants, 86% (25/29) completed all five sessions and FU1; surveys and exit interviews indicated high acceptability. Primary outcomes of cancer-related trauma symptoms and FoP improved significantly from pre to both follow-ups by predominantly large effect sizes. Secondary outcomes of anxiety, depression, hopelessness, fear of death/dying, and fatigue, and most process measures improved significantly by FU1 or FU2. Conclusions: EASE, a novel adaptation of written exposure therapy, is a promising approach to reducing FoP and cancer-related trauma symptoms among adults with advanced cancer that warrants further study.
Background and Objectives
Driving retirement can be a necessary but challenging and emotionally complex transition, especially for people living with dementia. This pilot study evaluated the utility of CarFreeMe™-Dementia (CFM™-D), a telehealth intervention providing tailored education and social support to those living with dementia and their care partners, as they prepare for or adjust to driving retirement. Delivered by empathetic health professionals, CFM™-D is a person-centric, flexible program tailored to address challenges specific to the participants’ driving retirement stage and individualized contexts.
Research Design and Methods
A single-arm, mixed-methods design was used to follow participants over a 6-month period. Participants received CFM™-D, a 7–8-module semistructured intervention, including education and planning support for driving retirement (impact of dementia, transportation options) and emotional adjustment (grief and loss, stress management). Surveys evaluated the perceived utility of intervention components as well as changes in well-being and readiness for driving retirement over time. An open-ended survey item and semistructured interviews provided additional feedback and a contextual understanding of the empirical data.
Results
A total of 50 families enrolled (17 care partners, 16 retiring/retired drivers with memory loss, and 17 care partner-retiring/retired driver dyads). Nearly all participants would recommend the intervention. Care partners reported significantly reduced (p < .05) isolation and relationship strain, and retiring drivers reported significant reductions in depressive symptoms. Driving retirement preparedness scores improved. Driving retirement phase, enrolling as a dyad, and retiring driver cognitive/functional impairment were associated with these outcomes. Participants also engaged in more driving retirement activities outside of the intervention (e.g., talking with health professionals).
Discussion and Implications
CFM™-D is a useful intervention for retiring drivers with dementia and their family members, with preliminary data suggesting it supports improved well-being and driving retirement preparedness. A randomized controlled trial is needed to determine the efficacy of the CFM™-D intervention and future translation needs.
Objective
Although patients with systemic lupus erythematosus (SLE) experience high levels of depression and anxiety disorders, evidence concerning patient perceptions of facilitators and barriers to effective uptake of mental health services (e.g., referral to therapists and psychiatrists, psychoeducational interventions, support groups) is limited.
Methods
We conducted semi‐structured qualitative interviews with 15 adults with SLE to explore patient experiences and perceptions of mental health services to identify facilitators and barriers to accessing mental health care among patients with SLE. Qualitative interviews were conducted via telephone and audio‐recorded for transcription and directed content analysis using NVivo software by two coders.
Results
Median age of the 15 participants was 48 years, 87% were female, 33% identified as Black or African American, and 33% identified as Hispanic or Latino. Qualitative themes were organized into three domains: barriers, facilitators, and preferences for mental health services. Barriers to use of mental health services included mental health stigma, sociodemographic factors, lack of autonomy, and time commitment. Facilitators to use of mental health services included strong relationships with their rheumatologists and mental healthcare clinician experience with SLE patients. Preferences for mental health services included educationally based formats, mental health providers who works with SLE patients, peer group formats, demographically and disease matched psychological resources, and emphasis on non‐disease related activities.
Conclusions
In the setting of persistent unmet psychosocial needs of patients living with SLE, data from this qualitative study will inform the development and refinement of mental health interventions that bolster psychological wellbeing in the SLE population.
INTRODUCTION
With Alzheimer's disease and related dementias (ADRD) representing an enormous public health challenge, there is a need to support individuals in learning about and addressing their modifiable risk factors (e.g., diet, sleep, and physical activity) to prevent or delay dementia onset. However, there is limited availability for evidence‐informed tools that deliver both quality education and support for positive behavior change such as by increasing self‐efficacy and personalizing goal setting. Tools that address the needs of Latino/a, at higher risk for ADRD, are even more scarce.
METHODS
We established a multidisciplinary team to develop the Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia (HALT‐AD) program, a bilingual online personalized platform to educate and motivate participants to modify their risk factors for dementia. Grounded in social cognitive theory and following a cultural adaptation framework with guidance from a community advisory board, we developed HALT‐AD iteratively through several cycles of rapid prototype development, user‐centered evaluation through pilot testing and community feedback, and refinement.
RESULTS
Using this iterative approach allowed for more than 100 improvements in the content, features, and design of HALT‐AD to improve the program's usability and alignment with the interests and educational/behavior change support needs of its target audience. Illustrative examples of how pilot data and community feedback informed improvements are provided.
DISCUSSION
Developing HALT‐AD iteratively required learning through trial and error and flexibility in workflows, contrary to traditional program development methods that rely on rigid, pre‐set requirements. In addition to efficacy trials, studies are needed to identify mechanisms for effective behavior change, which might be culturally specific. Flexible and personalized educational offerings are likely to be important in modifying risk trajectories in ADRD.
Background
Preliminary studies (e.g., pilot/feasibility studies) can result in misleading evidence that an intervention is ready to be evaluated in a large-scale trial when it is not. Risk of Generalizability Biases (RGBs, a set of external validity biases) represent study features that influence estimates of effectiveness, often inflating estimates in preliminary studies which are not replicated in larger-scale trials. While RGBs have been empirically established in interventions targeting obesity, the extent to which RGBs generalize to other health areas is unknown. Understanding the relevance of RGBs across health behavior intervention research can inform organized efforts to reduce their prevalence.
Purpose
The purpose of our study was to examine whether RGBs generalize outside of obesity-related interventions.
Methods
A systematic review identified health behavior interventions across four behaviors unrelated to obesity that follow a similar intervention development framework of preliminary studies informing larger-scale trials (i.e., tobacco use disorder, alcohol use disorder, interpersonal violence, and behaviors related to increased sexually transmitted infections). To be included, published interventions had to be tested in a preliminary study followed by testing in a larger trial (the two studies thus comprising a study pair). We extracted health-related outcomes and coded the presence/absence of RGBs. We used meta-regression models to estimate the impact of RGBs on the change in standardized mean difference (ΔSMD) between the preliminary study and larger trial.
Results
We identified sixty-nine study pairs, of which forty-seven were eligible for inclusion in the analysis (k = 156 effects), with RGBs identified for each behavior. For pairs where the RGB was present in the preliminary study but removed in the larger trial the treatment effect decreased by an average of ΔSMD=-0.38 (range − 0.69 to -0.21). This provides evidence of larger drop in effectiveness for studies containing RGBs relative to study pairs with no RGBs present (treatment effect decreased by an average of ΔSMD =-0.24, range − 0.19 to -0.27).
Conclusion
RGBs may be associated with higher effect estimates across diverse areas of health intervention research. These findings suggest commonalities shared across health behavior intervention fields may facilitate introduction of RGBs within preliminary studies, rather than RGBs being isolated to a single health behavior field.
Background: Long COVID is a serious public health concern due to its high prevalence and potentially debilitating symptoms. Symptoms may include fatigue, dyspnea, cognitive problems, insomnia, anxiety and depression. There is currently no cure for long COVID and the average length of recovery and proportion of patients who fully recover are still unknown. Subsequently, there is a critical need to improve function. Research in other chronic conditions suggests that psychosocial self-management interventions reduce symptom severity and interference with functioning. We describe the design of our study to examine the feasibility, acceptability, appropriateness and preliminary efficacy of an intervention designed to improve symptom management and coping in adults with long COVID.
Methods: This pilot trial (N=50) uses a pragmatic, randomized 2-group parallel design set within the MASKED Post-COVID Rehabilitation and Recovery Clinic. The self-management intervention is a 6-week, group-based telemedicine intervention that teaches evidence-based strategies to manage common symptoms and improve stress management as well as communication and self-advocacy. The comparator is a wait-list control. Participants complete self-report measures of the primary and secondary outcomes at baseline and post-treatment/wait-list. Primary outcomes include intervention feasibility, acceptability, and appropriateness. Secondary outcomes include Patient-Reported Outcomes Measurement Information System measures of fatigue, sleep disturbance, cognitive difficulties, self-efficacy, pain interference, depression and anxiety symptoms as well as a measure of long COVID symptoms and impression of change. At post-intervention, intervention participants also complete a qualitative interview to inform intervention refinement. Quantitative data will be examined using descriptive and statistical analysis including ttests and chi-square tests to compare the intervention and wait-list groups on secondary outcomes. Qualitative data will be analyzed using the rigorous and accelerated data reduction technique.
Discussion: Results of this pilot randomized controlled trial will characterize the feasibility, acceptability, and appropriateness of the self-management intervention and inform intervention refinement necessary prior to further testing. Long COVID is a public health concern and rehabilitation approaches that equip patients to manage symptoms may improve patient function and quality of life and reduce burden on the health system.
Clinical Trial Registration No.: NCT05658536.
Date of Trial Registration: December 16, 2022
Background: Many older adults with advanced heart failure receive home health rehabilitation after hospitalization. Yet, integration of palliative care skills into rehabilitation is limited. Objective: Describe using the Multiphase Optimization Strategy (MOST) framework with human-centered design principles to engage clinical partners in the Preparation phase of palliative physical therapy intervention development. Design: We convened a home-based physical therapy advisory team (four clinicians, three clinical leaders) to identify physical therapist needs and preferences for incorporating palliative care skills in rehabilitation and design an intervention prototype. Results: Between 2022 and 2023, we held five advisory team meetings. Initial feedback on palliative care skill preferences and training needs directly informed refinement of our conceptual model and skills in the intervention prototype. Later feedback focused on reviewing and revising intervention content, delivery strategy, and training considerations. Conclusion: Incorporating human-centered design principles within the MOST provided a useful framework to partner with clinical colleagues in intervention design.
Introduction
High variability in response and retention rates for posttraumatic stress disorder (PTSD) treatment highlights the need to identify "personalized" or "precision" medicine factors that can inform optimal intervention selection before an individual commences treatment. In secondary analyses from a non-inferiority randomized controlled trial, behavioral and physiological emotion regulation were examined as non-specific predictors (that identify which individuals are more likely to respond to treatment, regardless of treatment type) and treatment moderators (that identify which treatment works best for whom) of PTSD outcome.
Methods
There were 85 US Veterans with clinically significant PTSD symptoms randomized to 6 weeks of either cognitive processing therapy (CPT; n = 44) or a breathing-based yoga practice (Sudarshan kriya yoga; SKY; n = 41). Baseline self-reported emotion regulation (Difficulties in Emotion Regulation Scale) and heart rate variability (HRV) were assessed prior to treatment, and self-reported PTSD symptoms were assessed at baseline, end-of-treatment, 1-month follow-up, and 1-year follow-up.
Results
Greater baseline deficit in self-reported emotional awareness (similar to alexithymia) predicted better overall PTSD improvement in both the short- and long-term, following either CPT or SKY. High self-reported levels of emotional response non-acceptance were associated with better PTSD treatment response with CPT than with SKY. However, all significant HRV indices were stronger moderators than all self-reported emotion regulation scales, both in the short- and long-term. Veterans with lower baseline HRV had better PTSD treatment response with SKY, whereas Veterans with higher or average-to-high baseline HRV had better PTSD treatment response with CPT.
Conclusions
To our knowledge, this is the first study to examine both self-reported emotion regulation and HRV, within the same study, as both non-specific predictors and moderators of PTSD treatment outcome. Veterans with poorer autonomic regulation prior to treatment had better PTSD outcome with a yoga-based intervention, whereas those with better autonomic regulation did better with a trauma-focused psychological therapy. Findings show potential for the use of HRV in clinical practice to personalize PTSD treatment.
Clinical trial registration
ClinicalTrials.gov identifier, NCT02366403
Background and Objectives
Purpose in life is associated with healthier cognitive outcomes in older adulthood. This research examines within-person dynamics between momentary purpose and cognitive function to provide proof of concept that increases in purpose are associated with better cognitive performance.
Research Design and Methods
Participants (N=303; 54% female; Mage=51.71, SD=7.32) completed smartphone-based momentary assessments of purpose and short cognitive tasks three times a day for eight days.
Results
In moments when participants felt more purpose driven than their average, they had faster processing speed (b=-1.240, SE=0.194; p<.001), independent of person, temporal, and contextual factors and practice effects. Momentary purpose was unrelated to visual working memory performance (b=-0.001, SE=0.001; p=.475). In contrast to purpose, momentary hedonic affect (e.g., happiness) was unrelated to momentary cognition.
Discussion and Implications
Feeling more momentary purpose may support faster processing speed in daily life. Such evidence provides stage 0 support for a purpose-based intervention for healthier cognition, which may be particularly useful in middle adulthood and the transition to older adulthood before the onset of cognitive impairment.
This chapter begins by exploring the traditional Buddhist interpretation of mindfulness and then shifts to highlighting the increased interest in Eastern meditation techniques starting from the 1960s. It also covers the development of secular mindfulness-based programs, beginning with the implementation of mindfulness-based stress reduction initiatives in healthcare settings. From there, it expanded into mindfulness-based cognitive therapy aimed at preventing major depression relapses and gradually began to accommodate various populations and contexts. This chapter underscores the fact that over four decades of studies producing concrete scientific evidence on health outcomes have laid the foundation for mindfulness-based programs. Additionally, it provides extensive roadmaps on program adaptation by discussing principles and models. These inform how research can be utilized to refine a program, refining it to suit specific populations and environmental factors accordingly.
Introduction
Mind wandering, a phenomenon in which attention drifts away from the task-at-hand, is associated with deleterious effects on performance and well-being. As such, efforts to curb mind wandering are warranted. Recently, mindfulness training (MT) has been found to protect against mind wandering. Yet, many MT programs are at risk of falling off the implementation cliff due to challenges implementing these programs in applied settings. To mitigate against this, early-stage research in small convenience samples may be necessary to spur stakeholder engagement and collaboration. Herein, the effects of MT on mind wandering were examined via an internal meta-analysis of early-stage studies of a manualized, context-adaptable short-form MT program, referred to as Mindfulness-Based Attention Training (MBAT).
Methods
Five longitudinal studies (N = 304) were conducted in a variety of organizational cohorts. Self-reported mind wandering and meta-awareness, as well as accuracy (A’) and response time variability (intra-individual coefficient of variation, ICV) during performance of the sustained attention to response task (SART) were assessed at baseline (T1) and 4 weeks later (T2) in MBAT and no-training participants.
Results
Standardized mean change (SMC) from T1 to T2 significantly differed between MBAT and no-training groups for mind wandering (ΔSMC = −0.387, p < 0.001), meta-awareness (ΔSMC = −0.374, p < 0.001), and ICV (ΔSMC = −0.376, p = 0.043), suggesting potential protective effects in self-reported and performance-based metrics of mind wandering.
Discussion
These results serve as preliminary proof-of-concept support for MBAT’s protective effects on mind wandering. Further, they suggest that MBAT is amenable to implementation across a variety of applied and organizational settings and warrants additional research employing larger sample sizes in randomized controlled designs.
Engaging in contemplative practice like meditation, yoga, and prayer, is beneficial for psychological and physical well-being. Recent research has identified several underlying psychological and biological pathways that explain these benefits. However, there is not yet consensus on the underlying overlapping physiological mechanisms of contemplative practice benefits. In this article, we integrate divergent scientific literatures on contemplative practice interventions, stress science, and mitochondrial biology, presenting a unified biopsychosocial model of how contemplative practices reduce stress and promote physical health. We argue that engaging in contemplative practice facilitates a restorative state termed “deep rest,” largely through safety signaling, during which energetic resources are directed toward cellular optimization and away from energy-demanding stress states. Our model thus presents a framework for how contemplative practices enhance positive psychological and physiological functioning by optimizing cellular energy consumption.
Introduction: A growing number of patients with serious illness who would benefit from palliative care are part of ethnoracial minority groups. Nevertheless, large disparities in provision of palliative services exist for minoritized populations. Furthermore, there is a relative dearth of palliative care research focused on minority groups and how best to provide high-quality, culturally tailored palliative care. The aim of this narrative review is to summarize the existing literature regarding palliative care clinical trials in underrepresented minority populations, describe methodological approaches, and provide guidance on future palliative care-focused clinical trials. Methods: We used the Scale for the Assessment of Narrative Review Articles (SANRA) and Cochrane's guidelines on conducting reviews. We used PubMed and Clinicaltrials.gov to review published, full-text articles or protocols (1950-2022), and limited to palliative care interventions focused on ethnoracial minority populations. We included randomized clinical trials (RCTs), including pilot and feasibility trials, protocols of RCTs, and studies that report RCT methodology. Two reviewers independently assessed eligibility. Results: Our search yielded 585 publications; of these, 30 met the full-text review criteria and 16 studies met our criteria for inclusion. We deemed nine articles as having low risk of bias and four as having high risk of bias. Discussion: Commonly used methodologic approaches for clinical trials in underrepresented minority populations included the following: the use of written and visual materials that were no higher than a sixth-grade reading level, the use of patient and lay health navigators, bilingual and multicultural study staff and study materials, race-concordant staff, the option of in-person and virtual visits that accommodated the patient and family's schedule, recruitment from faith communities, and the use of community-engaged research principles. Future palliative care clinical trials should expand on the strategies described in this article, adopt effective strategies currently used in nonpalliative care interventions, and innovate around the principles of community-engaged research.
Attachment insecurity is a transdiagnostic marker of risk associated with interpersonal emotion dysregulation and adverse psychosocial outcomes across the lifespan. Few interventions target the enhancement of attachment security in late adolescence. Most programs focus on strengthening the adolescent-caregiver relationship; meanwhile, youth increasingly spend less time with their families and look to peer relationships as a source of connection, particularly as they transition to college. Drawing from the principles of Emotionally Focused Therapy, we developed a psychotherapeutic peer mentorship program to enhance attachment security for insecurely attached youth during the transition to college. We tested the preliminary efficacy of Emotionally Focused Mentorship (EFM) in an open pilot trial by pairing ( N = 82) insecurely attached first-year college students (i.e., “mentees”) with securely attached mentors. Across five weekly sessions, mentors helped mentees identify and express their emotions in close relationships by working through different relational scenarios. Attachment and mental health trajectories were self-reported three times over five weeks and analyzed using Bayesian growth curve models. Across five weeks, participants reported improvements in attachment anxiety and avoidance, emotion regulation difficulties, depressive symptoms, loneliness, and self-esteem. Participants who completed the intervention ( n = 55) noted improvements in their psychological wellbeing and interpersonal relationships. Results are promising and highlight the need to conduct a randomized clinical trial to test if these effects are causal. Given rising mental health demands, trained peer mentors may be a cost-effective way to improve attachment and psychological outcomes for insecurely attached participants during the transition to college.
Social anxiety disorder is one of the most prevalent anxiety disorders. There is a need to develop brief, virtual, single-session interventions targeting constructs associated with social anxiety, such as anxiety sensitivity social concerns (ASSC). ASSC is the maladaptive belief about consequences arising from observable symptoms of anxious arousal. This study was designed to evaluate the initial acceptability and feasibility of a brief ASSC reduction program (Brief Observable Anxiety Sensitivity Treatment [BOAST]) which included a single clinician-led intervention session followed by a two-week ecological momentary intervention (EMI), delivered via mobile app. Participants (N = 36) were adults with elevated ASSC who were randomly assigned to receive BOAST (n = 19) or a waitlist control (n = 17). The trial was prospectively registered at clinicaltrials.gov (NCT04859790). Results supported the acceptability of BOAST with mixed findings for feasibility. Feasibility metrics for the EMI component were below pre-defined thresholds; however, there was evidence that homework completion was associated with symptom reduction. Preliminary efficacy metrics indicated that participants in the BOAST condition had large reductions in ASSC and one measure of social anxiety at 1-month follow-up. This study provides preliminary support for the acceptability of BOAST and elucidates avenues for future clinical and research efforts.
Background. Student-athletes are one subgroup of college students in the United States at risk for dating violence and sexual risk behaviors. Despite this, research on student-athletes’ dating behaviors is limited; existing research pertains primarily to NCAA Division I athletes, and focuses on male student-athletes as perpetrators of dating and sexual violence. While some existing programs aim to reduce dating violence and promote healthy relationships, these programs are education-based, and not tailored to the specific strengths and challenges of student-athletes. We therefore designed Supporting Prevention in Relationships for Teams (SPoRT), a novel, four-session prevention intervention for Division III student-athletes of all genders to reduce dating violence and sexual risk behavior by targeting knowledge and skills identified in pilot research, incorporating psychoeducation with techniques from cognitive-behavioral therapy, mindfulness, bystander intervention, and normative feedback.
Methods. This study represents stage 1 of the NIH Stage Model for Behavioral Intervention Development, evaluating the feasibility and acceptability of SPoRT. We describe the development, content, and proposed delivery methods for SPoRT, and evaluated the feasibility and acceptability of the program using a mixed-methods approach. Thirty college student-athletes (12 men, 18 women) completed questionnaires and participated in focus groups to provide feedback on the program’s length, timing, group size and dynamics, content, and suggestions for making the SPoRT prevention intervention more feasible and acceptable.
Results. Our recruitment procedures were successful, and participants rated the program as feasible in terms of delivery methods and logistics. Participants liked that SPoRT was developed based on pilot data collected from student-athletes, brief, skills-based, and tailored to athletic team needs. SPoRT was perceived as appropriate and relevant to student-athlete needs in terms of dating violence and sexual risk prevention knowledge and skills. Most participants (63%) rated the program as “excellent” and said they would recommend it to others.
Conclusions. We found SPoRT to be both feasible and acceptable in terms of content and delivery. Suggested modifications will be incorporated into the SPoRT healthy relationships prevention intervention to be tested in an NIH Stage I efficacy trial.
Trial Registration: Not applicable.
Available for download at
http://nirn.fpg.unc.edu/resources/implementation-research-synthesis-literature
The role of clinical supervision in the larger-scale implementation of effective mental health treatments has begun to attract attention in effectiveness research and implementation science. Clinical supervision approaches demonstrated to support the implementation of effective treatments could provide a fruitful basis for adaptation to the contours and implementation of other interventions. The adaptation of the Multisystemic Therapy supervision model to support the implementation of an innovative, experimental mental health service model called Links to Learning is described. An observational study provides the platform for consideration of the extent to which the Links supervision model was implemented as intended and of challenges to Links implementation illuminated by the supervision process. Implications are considered for research on supervision as a tool to effect the implementation and outcomes of effective treatment and service models in community practice contexts.
Decades of clinical psychological science have produced empirically supported treatments that are now undergoing dissemination and implementation (DI) but with little guidance from a science that is just taking shape. Charting a future for DI science (DIS) and DI practice (DIP), and their complex relationship, will be complicated by significant challenges—the implementation cliff (intervention benefit drops when tested practices are scaled up), low relevance of most clinical research to actual practice, and differing timetables and goals for DIP versus DIS. To address the challenges, and prepare the next generation of clinical psychological scientists, we propose the following: making intervention research look more like practice, solving the “too many empirically supported treatments” problem, addressing mismatches between interventions and their users (e.g., clients, therapists), broadening the array of intervention delivery systems, sharpening outcome monitoring and feedback, incentivizing high-risk/high-gain innovations, designing new professional tracks, and synchronizing and linking the often-insular practice and science of DI.
Background
Current diagnostic systems for mental disorders rely upon presenting signs and symptoms, with the result that current definitions do not adequately reflect relevant neurobiological and behavioral systems - impeding not only research on etiology and pathophysiology but also the development of new treatments.
Discussion
The National Institute of Mental Health began the Research Domain Criteria (RDoC) project in 2009 to develop a research classification system for mental disorders based upon dimensions of neurobiology and observable behavior. RDoC supports research to explicate fundamental biobehavioral dimensions that cut across current heterogeneous disorder categories. We summarize the rationale, status and long-term goals of RDoC, outline challenges in developing a research classification system (such as construct validity and a suitable process for updating the framework) and discuss seven distinct differences in conception and emphasis from current psychiatric nosologies.
Summary
Future diagnostic systems cannot reflect ongoing advances in genetics, neuroscience and cognitive science until a literature organized around these disciplines is available to inform the revision efforts. The goal of the RDoC project is to provide a framework for research to transform the approach to the nosology of mental disorders.
Sweeping and profound structural, regulatory, and fiscal changes are rapidly reshaping the contours of health and mental health practice. The community-based practice contexts described in the excellent review by Garland and colleagues are being fundamentally altered with different business models, regional networks, accountability standards, and incentive structures. If community-based mental health services are to remain viable, the two-dimensional and flat research and practice paradigm has to be replaced with three-dimensional thinking. Failure to take seriously the changes that are happening to the larger healthcare context and respond actively through significant system redesign will lead to the demise of specialty mental health services.
As the study of psychological treatments begins to mature beyond questions of efficacy, investigators are focusing more on treatment mediators in an effort to aid revision and dissemination of existing treatments. Often, such studies are conducted without wait-list or no-treatment control groups. However, designs without a control group constrain the examination of treatment mediators and preclude statements about the overall effects of treatment. We review the limitations of treatment-treatment and single-treatment designs for studying mediation and suggest design modifications to strengthen future investigations. Specifically, we present the benefits and limitations of regression discontinuity and interrupted time series in testing mediation when ethical or organizational considerations preclude simple random assignment to a no-treatment condition.
The progressively rigorous methodological requirements of conducting clinical trials of behavioral treatments has placed a large burden on individual investigators, as treatment manuals, methods of evaluating treatment quality and fidelity, and persuasive evidence of the treatment's promise are now virtual requirements of receiving support for conducting a clinical trial of a new or adapted treatment. A Stage Model of Behavioral Therapies research, by articulating the progressive stages of development and evaluation for behavioral treatments, recognizes the scientific merit and need for support for treatment development and initial evaluation designated as stage I. This article describes the conduct of stage I research, including issues addressed in stage I research, major design decisions confronted by investigators, the close relationship of stage I to stage II research and proposes a time line for stage I research.
The stage model of therapy research focuses on the development of treatment from pilot work, through randomized controlled clinical trials, to tests in clinic settings. A goal of the model is to develop effective treatments that can be used clinically. The present comments begin with a similar goal but emphasize the importance of a broader agenda designed to understand therapy. A central thesis is that developing effective treatments depends heavily on investigations that address critical scientific questions; particularly, what are the mechanisms through which therapy operates and under what conditions is therapy likely to be effective and why? The comments argue for a portfolio of research that addresses a broader range of questions and encompasses more diverse methods of evaluating treatment. Breadth and diversity are not ends in themselves but will be essential to obtain the requisite knowledge to effect optimal changes in clinical applications of treatment.
This article presents the results of a qualitative analysis of interviews with 25 psychologists in independent practice, investigating everyday treatment decisions and attitudes about treatment outcome research and empirically supported treatments (ESTs). Clinicians noted positive aspects about treatment outcome research, such as being interested in what works. However, they had misgivings about the application of controlled research findings to their practices, were skeptical about using manualized protocols, and expressed concern that nonpsychologists would use EST lists to dictate practice. Clinicians reported practicing in an eclectic framework, and many reported including cognitive-behavioral elements in their practice. To improve their practice, they reported valuing clinical experience, peer networks, practitioner-oriented books, and continuing education when it was not too basic. Time and financial barriers concerned nearly all participants. Clinicians suggested they might be interested in ESTs if they could integrate them into their current frameworks, and if resources for learning ESTs were improved.
Post-traumatic stress disorder (PTSD) is a highly prevalent, often chronic and disabling psychiatric disorder that is associated with significant adverse health and life consequences. Fortunately, there is compelling evidence that cognitive-behavioral therapies, notably exposure therapies, are effective in reducing PTSD symptomology relative to waiting list and active control conditions. Prolonged exposure is a specific exposure therapy program that is considered a first-line evidence-based treatment for PTSD. Unfortunately, barriers to treatment dissemination prevent the majority of individuals with PTSD from receiving evidence-based treatment. Strategies to increase the availability of treatment and boost the efficiency of exposure therapy are now being examined.
Little is known about whether cognitive behavioral therapy (CBT) or pharmacotherapy is relatively more advantageous for depressive versus anxiety disorders.
We conducted a meta-analysis wherein we searched electronic databases and references to select randomized controlled studies comparing CBT and pharmacotherapy, with or without placebo, in adults with major depressive or anxiety disorders. The primary effect size was calculated from disorder-specific outcome measures as the difference between CBT and pharmacotherapy outcomes (i.e., positive effect size favors CBT; negative effect size favors pharmacotherapy).
Twenty-one anxiety (N = 1,266) and twenty-one depression (N = 2,027) studies comparing medication to CBT were included. Including all anxiety disorders, the overall effect size was.25 (95% CI: -0.02, 0.55, P =.07). Effects for panic disorder significantly favored CBT over medications (.50, 95% CI: 0.02, 0.98). Obsessive-compulsive disorder showed similar effects-sizes, though not statistically significant (.49, 95% CI: -0.11, 1.09). Medications showed a nonsignificant advantage for social anxiety disorder (-.22, 95% CI: -0.50, 0.06). The overall effect size for depression studies was.05 (95% CI: -0.09, 0.19), with no advantage for medications or CBT. Pooling anxiety disorder and depression studies, the omnibus comparison of the relative difference between anxiety and depression in effectiveness for CBT versus pharmacotherapy pointed to a nonsignificant advantage for CBT in anxiety versus depression (B =.14, 95% CI: -0.14, 0.43).
On balance, the evidence presented here indicates that there are at most very modest differences in effects of CBT versus pharmacotherapy in the treatment of anxiety versus depressive disorders. There seems to be larger differences between the anxiety disorders in terms of their relative responsiveness to pharmacotherapy versus CBT.
Sustained and effective use of evidence-based practices in substance abuse treatment services faces both clinical and contextual challenges. Implementation approaches are reviewed that rely on variations of plan-do-study-act (PDSA) cycles, but most emphasize conceptual identification of core components for system change strategies. A two-phase procedural approach is therefore presented based on the integration of Texas Christian University (TCU) models and related resources for improving treatment process and program change. Phase 1 focuses on the dynamics of clinical services, including stages of client recovery (cross-linked with targeted assessments and interventions), as the foundations for identifying and planning appropriate innovations to improve efficiency and effectiveness. Phase 2 shifts to the operational and organizational dynamics involved in implementing and sustaining innovations (including the stages of training, adoption, implementation, and practice). A comprehensive system of TCU assessments and interventions for client and program-level needs and functioning are summarized as well, with descriptions and guidelines for applications in practical settings.
The capacity to deliver some forms of behavioral treatment via computers may prove to be a small revolution in the delivery of mental health care. Although early research on the efficacy of these approaches has yielded mixed results, this new strategy offers tremendous potential to provide empirically supported therapies to many individuals who would never access psychiatric care, to extend the time and expertise of clinicians, and to offer improved care and monitoring. However, the great promise of computer-assisted therapies may be diminished if their benefits are overstated or if they are broadly released or disseminated before being carefully evaluated using the same methodologic standards that are requirements for evaluating clinician-delivered therapies. In this article, we review the current status of empiric support for computer-assisted therapies, advocating for enhanced rigor to identify those that are most effective, as well as the need to more thoroughly assess possible adverse effects, recognizing that even a modestly effective computer-assisted intervention could have enormous impact.
An investigator who plans to conduct an experiment with multiple independent variables must decide whether to use a complete or reduced factorial design. This article advocates a resource management perspective on making this decision, in which the investigator seeks a strategic balance between service to scientific objectives and economy. Considerations in making design decisions include whether research questions are framed as main effects or simple effects; whether and which effects are aliased (confounded) in a particular design; the number of experimental conditions that must be implemented in a particular design and the number of experimental subjects the design requires to maintain the desired level of statistical power; and the costs associated with implementing experimental conditions and obtaining experimental subjects. In this article 4 design options are compared: complete factorial, individual experiments, single factor, and fractional factorial. Complete and fractional factorial designs and single-factor designs are generally more economical than conducting individual experiments on each factor. Although relatively unfamiliar to behavioral scientists, fractional factorial designs merit serious consideration because of their economy and versatility.
A wealth of evidence attests to the extensive current and lifetime diagnostic comorbidity of the Diagnostic and Statistical Manual of Mental Disorders (4th ed., DSM-IV) anxiety and mood disorders. Research has shown that the considerable cross-sectional covariation of DSM-IV emotional disorders is accounted for by common higher order dimensions such as neuroticism/behavioral inhibition (N/BI) and low positive affect/behavioral activation. Longitudinal studies indicate that the temporal covariation of these disorders can be explained by changes in N/BI and, in some cases, initial levels of N/BI are predictive of the temporal course of emotional disorders. The marked phenotypal overlap of the DSM-IV anxiety and mood disorders is a frequent source of diagnostic unreliability (e.g., temporal overlap in the shared features of generalized anxiety disorder and mood disorders, situation specificity of panic attacks in panic disorder and specific phobia). Although extant dimensional proposals may address some drawbacks associated with the DSM nosology (e.g., inadequate assessment of individual differences in disorder severity), these proposals do not reconcile key problems in current classification, such as modest reliability and high comorbidity. This article considers an alternative approach that emphasizes empirically supported common dimensions of emotional disorders over disorder-specific criteria sets. Selection and assessment of these dimensions are discussed along with how these methods could be implemented to promote more reliable and valid diagnosis, prognosis, and treatment planning. For instance, the advantages of this system are discussed in context of transdiagnostic treatment protocols that are efficaciously applied to a variety of disorders by targeting their shared features.
Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts.
We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts.
The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct.
The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.
One of the most critical issues in mental health services research is the gap between what is known about effective treatment and what is provided to consumers in routine care. Concerted efforts are required to advance implementation science and produce skilled implementation researchers. This paper seeks to advance implementation science in mental health services by over viewing the emergence of implementation as an issue for research, by addressing key issues of language and conceptualization, by presenting a heuristic skeleton model for the study of implementation processes, and by identifying the implications for research and training in this emerging field.
Little is known about how psychological treatments work. Research on treatment-induced mediators of change may be of help in identifying potential causal mechanisms through which they operate. Outcome-focused randomised controlled trials provide an excellent opportunity for such work. However, certain conceptual and practical difficulties arise when studying psychological treatments, most especially deciding how best to conceptualise the treatment concerned and how to accommodate the fact that most psychological treatments are implemented flexibly. In this paper, these difficulties are discussed, and strategies and procedures for overcoming them are described.
( This reprinted article originally appeared in Journal of Consulting Psychology, 1952, Vol 16, 319–324. The following abstract of the original article appeared in PA, Vol 27:5921. ) A survey was made of reports on the improvement of neurotic patients after psychotherapy, and the results compared with the best available estimates of recovery without benefit of such therapy. The figures fail to support the hypothesis that psychotherapy facilitates recovery from neurotic disorder. In view of the many difficulties attending such actuarial comparisons, no further conclusions could be derived from the data whose shortcomings highlight the necessity of properly planned and executed experimental studies into this important field.
The Delaware Project, initiated in a conference at the University of Delaware, aims to redefine psychological clinical science training in ways that emphasize continuity across a spectrum of intervention development activities ranging from basic research to implementation and dissemination. The project generated specific recommendations for elevating dissemination and implementation, both at different stages of clinical science training and in different training settings, and highlighted several experiential training innovations to foster this goal. The project also helped sharpen competing priorities of two broad approaches to intervention science: one emphasizing translation, or moving from basic research to systematic applications in practice, and the other privileging dissemination-implementation per se, where a priority is understanding and maximizing the accessibility, acceptability, adaptability, and sustainability of interventions in the contexts where practitioners deliver them. The training of future clinical scientists will be crucial to reconciling these perspectives on how best to address significant public health problems.
A five-year follow-up of 30 phobics originally identified in a population survey, revealed that untreated phobia tends to improve. Children's phobias improve quickly, 100% being improved or recovered at the end of five years. Adult's phobias improve more slowly, 43% being improved or recovered, 20% unchanged, and 33.0% worse at the end of five years. Severity of the phobia was not predictive of outcome, however degree of generalization of the phobia, and fearfulness, were. High generalization and fearfulness were associated with poor outcome. The similarity of these findings to follow-up studies of treated phobia suggests common mechanisms underlying recovery in both treated and untreated cases. A review of recent findings suggests that exposure to the feared object or situation is the common mechanism.
An abundance of research from diverse areas of psychological science is potentially relevant to behavioral therapy development research. The National Institute on Drug Abuse of the National Institutes of Health convened a workshop to reinforce the connection between basic behavioral and therapy development research. The articles in this Special Section are the product of this workshop. Several lines of basic behavioral research are described, and implications for the development of behavioral therapies are discussed. This Special Section highlights the notion that strengthening the bond between behavioral therapy development research and basic behavioral science will accelerate the advancement of knowledge about behavior, behavioral change, and therapeutic interventions.
Treatment researchers expend their efforts identifying effective treatments, and for whom and how they work, but there are matters over and above these that are of concern when it comes to dissemination and implementation. These include the clinical range of the interventions concerned, the ease with which they can be learned, and their mode of delivery. It is these three topics, as they apply to the psychological treatment of eating disorders, that form the focus of this article. Alongside these considerations, we discuss how modern technology has the potential to transform both treatment and training. © 2013 by Wiley Periodicals, Inc. (Int J Eat Disord 2013; 46:516-521).
The field of eating disorders (EDs) treatment has been beset by a marked disjunction between scientific evidence and clinical application. We describe the nature and scope of the research-practice gap in the ED field.
We draw on surveys and broader literature to better understand the research-practice gap in ED treatment and reasons for resistance to evidence-based practice.
We identify three sources of the research-practice gap: (1) attitudinal factors, (2) differences in the definition of "evidence," and (3) cognitive factors, especially naïve realism and confirmation bias. We affirm the role of science as a safeguard against human fallibility and as a means of bridging the research-practice gap, and delineate key principles of scientific thinking for ED researchers and practitioners.
We conclude with proposals for narrowing the research-practice gap in ED treatment and enhancing the quality of interventions for ED clients. © 2013 by Wiley Periodicals, Inc. (Int J Eat Disord 2013; 46:386-394).
The present paper argues that traditional approaches to treatment development, including a technological approach, a stage model, and existing inductive approaches such as functional analysis are inadequate in various ways. Treatment developing needs to focus more on theoretical development, practicality, and the fit with clients and practitioners. We argue that progress requires greater philosophical clarity, and steps to ensure a connection between philosophy of science assumptions and an analytic agenda which fits naturally with applied psychology. Theoretical progress requires distinguishing between clinical and basic models and harmonizing their relationship, and more focus on the manipulable context of action. Applied psychology needs to join in a common cause with basic psychology in domains of mutual interest, and develop basic analyses and mid-level terms that can be both scientifically progressive and clinically useful. Issues of practicality, capacity for dissemination, and public health impact need to be considered at the beginning and throughout treatment development. Issues of effectiveness, change processes, mediation, moderation, training, active components, and similar issues should be part of the evaluation system from the beginning. It is time to create a more coherent approach to treatment innovation.
Five decades of randomized trials research have produced dozens of evidence-based psychotherapies (EBPs) for youths. The EBPs produce respectable effects in traditional efficacy trials, but the effects shrink markedly when EBPs are tested in practice contexts with clinically referred youths and compared to usual clinical care. We considered why this might be the case. We examined relevant research literature and drew examples from our own research in practice settings. One reason for the falloff in EBP effects may be that so little youth treatment research has been done in the context of everyday practice. Researchers may have missed opportunities to learn how to make EBPs work well in the actual youth mental health ecosystem, in which so many real-world factors are at play that cannot be controlled experimentally. We sketch components and characteristics of that ecosystem, including clinically referred youths, their caregivers and families, the practitioners who provide their care, the organizations within which care is provided, the network of youth service systems (e.g., child welfare, education), and the policy context (e.g., reimbursement regulations and incentives). We suggest six strategies for future research on EBPs within the youth mental health ecosystem, including reliance on the deployment-focused model of development and testing, testing the mettle of current EBPs in everyday practice contexts, using the heuristic potential of usual care, testing restructured and integrative adaptations of EBPs, studying the use of treatment response feedback to guide clinical care, and testing models of the relation between policy change and EBP implementation.
In this chapter, a conceptualization of the stages of behavioral or psychosocial therapy research is presented. The ideas are intended to stimulate thought about the process of behavioral therapy research, its various essential components, and the most logical and pragmatic ways in which this process and its components can be viewed. (PsycINFO Database Record (c) 2012 APA, all rights reserved)
There has been a steady retreat by the private sector away from developing medications for mental disorders. This retreat comes just as research is identifying new molecular targets, new clinical targets, and new uses of current treatments that may serve as the basis for the next generation of treatments for mental disorders.
Brief cognitive-behavioral therapy for panic disorder has the potential to lower health care costs and enhance dissemination of evidence-based interventions to clinical practice. This manuscript evaluates the utility of brief cognitive-behavioral therapy for panic disorder.
A narrative review of studies examining the efficacy of cognitive-behavioral brief treatment of panic disorder, with a specific focus on an ultra-brief, 5-session, intervention developed by our group.
Brief cognitive-behavioral therapy for panic disorder is associated with clinically meaningful symptom improvement reflecting large effect sizes, comparable to those observed for standard protocols.
Growing evidence encourages the further evaluation and application brief cognitive-behavioral therapy for panic disorder. Controlled trials of cognitive-behavioral therapy have established the dramatic benefit that can be offered by brief treatment (often 12-15 sessions) approaches for Axis I disorders. Yet, as the field advances and core mechanisms of change are identified, there is the potential for offering efficacy in even briefer treatment protocols. In this manuscript, we describe the elements and initial efficacy estimates, based on published studies, for an ultra-brief treatment approach for panic disorder. We also discuss the potential impact, and such brief treatment can have relative to dissemination issues and the desire for the timely end to psychological suffering.
In this paper, a view of the nature, purpose, and methods of experimentally controlled between-group therapy outcome research is presented. It is argued that the greatest progress in the development of increasingly useful interventions based on between-group therapy designs will come from (a) viewing such controlled therapy outcome research as basic science in which knowledge is acquired through experimental designs constructed to yield specific cause-and-effect conclusions and (b) combining this form of research with the clinical and nonclinical types more commonly called “basic research.” © 1999 John Wiley & Sons, Inc. J Clin Psychol 55: 147–158, 1999.
Generalized anxiety disorder (GAD) is a common and disabling condition associated with significant personal and societal costs. Although efficacious treatments exist for GAD, the majority of these individuals fail to access our most effective treatments. In the current paper, we report the results of an open trial that examined the efficacy of a computer-delivered home-based treatment program for GAD. Twenty-one individuals seeking treatment for GAD received a self-administered program over 6 weeks that comprised two components: (1) an Attention Modification Program (AMP) designed to facilitate attentional disengagement from threat-relevant stimuli and (2) brief computer-delivered cognitive and behavioral treatment modules (CCBT). Fourteen of the 21 enrolled participants (67%) completed the treatment program. Intent-to-treat and completer analyses revealed that AMP+CCBT resulted in significant reductions in clinician- and self-rated symptoms of anxiety, worry, depression, and functional impairment. Moreover, treatment completers displayed significant reductions in attentional bias for threat from pre- to postassessment. Change in attentional bias for threat from pre- to postassessment was associated with change in worry symptoms. Finally, 79% of participants no longer met DSM-IV criteria for GAD at postassessment and 36% were classified as remitted (Hamilton Rating Scale for Anxiety ≤7; Rickels et al., 2006). These results suggest that computer-delivered AMP+CCBT may serve as an effective and easily accessible treatment option for individuals with GAD.
To identify barriers to the dissemination of empirically supported treatments (ESTs), a random sample of psychologists in independent practice (N=1291) was asked to complete measures of attitudes towards ESTs and willingness to attend a 3-hour, 1-day, or 3-day workshop in an EST of their choice. The strongest predictor of unwillingness to obtain EST training was the amount of time and cost required for the workshop, followed by objections to the need for EST training. Psychodynamic (compared to cognitive-behavioral) and more experienced practitioners agreed more strongly with the objections to ESTs overall, as did those whose graduate schools had not emphasized psychotherapy research. Results suggest that both practical and theoretical barriers are significant obstacles to EST dissemination.
Given that most addiction counselors enter the field unprepared to implement psychosocial evidence-based practices (EBPs), surprisingly little is known about the extent to which substance abuse treatment centers provide their counselors with formal training in these treatments. This study examines the extent of formal training that treatment centers provide their counselors in cognitive behavioral therapy (CBT), motivational interviewing (MI), contingency management (CM), and brief strategic family therapy (BSFT).
Face-to-face interviews with 340 directors of a nationally representative sample of privately funded US substance abuse treatment centers.
Although a substantial number of treatment centers provide their counselors with formal training in EBPs that they use with their clients, coverage is far from complete. For example, of those centers that use CBT, 34% do not provide their counselors with any formal training in CBT (either initially or annually), and 61% do not provide training in CBT that includes supervised training cases. Sizable training gaps exist for MI, CM, and BSFT as well.
The large training gaps found in this study give rise to concerns regarding the integrity with which CBT, MI, CM, and BSFT are being delivered by counselors in private US substance abuse treatment centers. Future research should examine the generalizability of our findings to other types of treatment centers (e.g., public) and to the implementation of other EBPs.
To inform policy makers on available options for improving the effectiveness of treatments for substance use disorders and to stimulate debate about treatment improvement strategies among public officials, clinical providers, care managers, service users, families and researchers.
We draw on the scientific literature and our public policy experiences in two countries (the United Kingdom and the United States) to give an overview of policies which may improve care for individuals with substance use disorders. We divide such policies into 'process-focused quality improvement strategies' that attempt to change some aspect of treatment (e.g. increased retention, greater use of evidence-based practices) and 'patient-focused strategies' that attempt to reward outcomes directly (e.g. contingency management for patients, payment by results for providers).
Many policies of both types are poorly developed, have shown poor results, or both. The evidence is clear that process-focused quality improvement strategies can change what providers do and how treatment programs work, but such changes have thus far demonstrated only minimal impact on patient outcomes. Patient-focused strategies face challenges including treatment providers avoiding hard-to-treat patients or spending inordinate time relocating patients after treatment to assess outcome. However, policies that reward in-treatment outcomes and policies that allow the patient to purchase desired recovery support services show more promise. As policy makers go forward in this endeavor, they can do an enormous service to their countries and the field by embedding careful evaluation studies alongside new treatment outcome improvement initiatives.
Efficacy trials have generated interventions to improve health behaviors and biomarkers. However, these efforts have had limited impact on practice and policy. It is suggested that key methodologic and contextual issues have contributed to this state of affairs. Current research paradigms generally have not provided the answers needed for more probable and more rapid translation. A major shift is proposed to produce research with more rapid clinical, public health, and policy impact.
The 35-year progression of multisystemic therapy (MST) from modest university-based efficacy studies to large-scale transport to community practice settings is described in this review. The success of early efficacy research led to effectiveness trials, and their success in decreasing rates of youth rearrest and incarceration led to multisite transportability trials and adaptations of the MST model for treating youth presenting other types of challenging clinical problems. To support the transport of MST programs to community settings, an intensive quality improvement system modeled after that used in clinical trials has been implemented in community-based MST programs for the past 15 years. With the association between therapist treatment fidelity and youth outcomes well established, transportability research has demonstrated the significant roles played by clinical supervisors, expert consultants, and provider organizations in supporting therapist adherence and youth outcomes. This body of work has been facilitated by federal and state initiatives to support evidence-based services.
[Clin Psychol Sci Prac 17: 1–30, 2010]
Evidence-based practice (EBP), a preferred psychological treatment approach, requires training of community providers. The systems-contextual (SC) perspective, a model for dissemination and implementation efforts, underscores the importance of the therapist, client, and organizational variables that influence training and consequent therapist uptake and adoption of EBP. This review critiques the extant research on training in EBP from an SC perspective. Findings suggest that therapist knowledge improves and attitudinal change occurs following training. However, change in therapist behaviors (e.g., adherence, competence, and skill) and client outcomes only occurs when training interventions address each level of the SC model and include active learning. Limitations as well as areas for future research are discussed.
The escalating costs of health care and other recent trends have made health care decisions of great societal import, with decision-making responsibility often being transferred from practitioners to health economists, health plans, and insurers. Health care decision making increasingly is guided by evidence that a treatment is efficacious, effective–disseminable, cost-effective, and scientifically plausible. Under these conditions of heightened cost concerns and institutional–economic decision making, psychologists are losing the opportunity to play a leadership role in mental and behavioral health care: Other types of practitioners are providing an increasing proportion of delivered treatment, and the use of psychiatric medication has increased dramatically relative to the provision of psychological interventions.
Research has shown that numerous psychological interventions are efficacious, effective, and cost-effective. However, these interventions are used infrequently with patients who would benefit from them, in part because clinical psychologists have not made a convincing case for the use of these interventions (e.g., by supplying the data that decision makers need to support implementation of such interventions) and because clinical psychologists do not themselves use these interventions even when given the opportunity to do so.
Clinical psychologists' failure to achieve a more significant impact on clinical and public health may be traced to their deep ambivalence about the role of science and their lack of adequate science training, which leads them to value personal clinical experience over research evidence, use assessment practices that have dubious psychometric support, and not use the interventions for which there is the strongest evidence of efficacy. Clinical psychology resembles medicine at a point in its history when practitioners were operating in a largely prescientific manner. Prior to the scientific reform of medicine in the early 1900s, physicians typically shared the attitudes of many of today's clinical psychologists, such as valuing personal experience over scientific research. Medicine was reformed, in large part, by a principled effort by the American Medical Association to increase the science base of medical school education. Substantial evidence shows that many clinical psychology doctoral training programs, especially PsyD and for-profit programs, do not uphold high standards for graduate admission, have high student–faculty ratios, deemphasize science in their training, and produce students who fail to apply or generate scientific knowledge.
A promising strategy for improving the quality and clinical and public health impact of clinical psychology is through a new accreditation system that demands high-quality science training as a central feature of doctoral training in clinical psychology. Just as strengthening training standards in medicine markedly enhanced the quality of health care, improved training standards in clinical psychology will enhance health and mental health care. Such a system will (a) allow the public and employers to identify scientifically trained psychologists; (b) stigmatize ascientific training programs and practitioners; (c) produce aspirational effects, thereby enhancing training quality generally; and (d) help accredited programs improve their training in the application and generation of science. These effects should enhance the generation, application, and dissemination of experimentally supported interventions, thereby improving clinical and public health. Experimentally based treatments not only are highly effective but also are cost-effective relative to other interventions; therefore, they could help control spiraling health care costs. The new Psychological Clinical Science Accreditation System (PCSAS) is intended to accredit clinical psychology training programs that offer high-quality science-centered education and training, producing graduates who are successful in generating and applying scientific knowledge. Psychologists, universities, and other stakeholders should vigorously support this new accreditation system as the surest route to a scientifically principled clinical psychology that can powerfully benefit clinical and public health.
The DSM-V development process started with a grand ambition to provide a 'paradigm shift' in psychiatric diagnosis, based initially on the identification of biological markers. This is clearly unattainable, and so energy has now been diverted into developing other major changes, including the development of dimensional ratings and the formal diagnosis of prodromal and subthreshold disorders. It is argued that this process could lead to false positive 'epidemics' with harmful excessive treatments. The better, more modest, alternative is to reassess the text descriptions of the disorders and join with ICD-11 in creating a single nested system for both DSM-V and ICD-11.
This article provides an empirical review of the elements and efficacy of both pharmacologic and psychosocial treatments for panic disorder. Both monotherapies and combination treatment strategies are considered. The available evidence suggests that both cognitive behavioral therapy (CBT) and pharmacotherapy (prominently, selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors) are effective first-line agents and that CBT offers particular cost efficacy relative to both pharmacotherapy alone and combined pharmacotherapy and CBT. Predictors of non-response and mechanisms of action are considered, as are novel treatment strategies, including the use of memory enhancers to improve CBT outcome.
In this article, the authors assess the successes, remaining challenges, and new developments in cognitive behavioral therapy (CBT) for anxiety disorders. They define CBT, examine treatment components, review treatment efficacy, and discuss the challenges of attrition, long-term follow-up, co-occurring/comorbid disorders, limited treatment comparisons, treatment mediators, and broader implementation. In addition, they present recent developments in cognitive behavioral therapy for anxiety disorders, including linking exposure therapy to basic science, mindfulness and acceptance-based treatments, and unified or transdiagnostic treatment protocols.
Anxiety disorders are common, costly and debilitating, and yet often unrecognized or inadequately treated in real world, primary care settings. Our group has been researching ways of delivering evidence-based treatment for anxiety in primary care settings, with special interest to preserving the fidelity of the treatment while at the same time promoting its sustainability once the research is over. In this paper, we describe the programs we have developed and our directions for future research. Our first study evaluated the efficacy of CBT and expert pharmacotherapy recommendations for panic disorder in primary care, using a collaborative care model of service delivery (CCAP). Symptom, disability and mental health functioning measures were superior for the intervention group compared to treatment as usual both in the short term and the long term, although also more costly. In our ongoing CALM study, we have extended our population to include panic disorder, social anxiety disorder, generalized anxiety disorder and posttraumatic disorder, while at the same time utilizing clinicians with limited mental health care experience. In addition to pharmacotherapy management, we developed a computer-assisted CBT that guides both novice clinician and patient, thereby contributing to sustainability once the research is over. We have also incorporated a measurement based approach to treatment planning, using a web-based tracking system of patient status. To date, the computer-assisted CBT program has been shown to be acceptable to clinicians and patients. Clinicians rated the program highly, and patients engaged in the program. Future directions for our research include dissemination and implementation of the CALM program, testing potential alternations to the CALM program, and distance delivery of CALM.
This article describes a computer-assisted cognitive behavioral therapy (CBT) program designed to support the delivery of evidenced-based CBT for the four most commonly occurring anxiety disorders (panic disorder, posttraumatic stress disorder, generalized anxiety disorder, and social anxiety disorder) in primary-care settings. The purpose of the current report is to (1) present the structure and format of the computer-assisted CBT program, and (2) to present evidence for acceptance of the program by clinicians and the effectiveness of the program for patients.
Thirteen clinicians using the computer-assisted CBT program with patients in our ongoing Coordinated Anxiety Learning and Management study provided Likert-scale ratings and open-ended responses about the program. Rating scale data from 261 patients who completed at least one CBT session were also collected.
Overall, the program was highly rated and modally described as very helpful. Results indicate that the patients fully participated (i.e., attendance and homework compliance), understood the program material, and acquired CBT skills. In addition, significant and substantial improvements occurred to the same degree in randomly audited subsets of each of the four primary anxiety disorders (N=74), in terms of self ratings of anxiety, depression, and expectations for improvement.
Computer-assisted CBT programs provide a practice-based system for disseminating evidence-based mental health treatment in primary-care settings while maintaining treatment fidelity, even in the hands of novice clinicians.