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Abstract

Although irritable bowel syndrome (IBS) is highly prevalent and is accompanied by high costs for respective healthcare systems, the data on treatment effectiveness are limited. Current treatment methods have limitations in terms of side effects and availability. Guided self-help (GSH) might be an easily accessible and cost-effective treatment alternative. This study is the first systematic review and meta-analysis of GSH interventions for IBS. Using electronic databases (MEDLINE, SCOPUS, PsycINFO, and Web of Science), we performed a systematic search for randomized-controlled trials. Using a random-effect model, we calculated the pooled standardized mean differences (SMDs) of GSH on IBS symptom severity (primary outcome) and quality of life (secondary outcome). We additionally examined the moderating effects of online-based interventions and face-to-face therapist contact by applying mixed models. A systematic literature search identified 10 eligible randomized-controlled trials, including 886 participants. Compared with the control conditions, the effect size was medium for the decrease in IBS symptom severity (SMD=0.72; 95% confidence interval: 0.34-1.08) and large for the increase in patients' quality of life (SMD=0.84; 95% confidence interval: 0.46-1.22). Neither treatment format nor face-to-face contact was a predictor of therapy outcomes in between-group analyses. In contrast, within-group analyses led to the conclusion that online-based interventions are more effective than other self-help formats. GSH is an effective alternative for the treatment of IBS. As GSH methods are easy to implement, it seems sensible to integrate GSH into clinical practice. With respect to the high study heterogeneity, the number of studies included was relatively small.

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... As an emerging healthcare instrument, Internet-based interventions (IBIs) strive to enhance existing treatment options, prevent symptom burden and the chronicity of somatic complaints, and offer lowthreshold, flexible treatment that could engage first-time help-seekers. A growing research base shows that IBIs, which are mostly designed as modular, guided-self-help interventions based on principles of CBT, can effectively reduce somatic symptom severity in individuals with PSS of varying etiology and across age groups [18][19][20][21][22][23]. However, there are a wide range of (small to large-sized) effects, depending for example on the clinical outcomes or the type of PSS studied [22,24]. ...
... Also, studies have reported mixed findings regarding whether higher baseline somatic symptom severity predicts better outcomes of psychological treatments [30,31]. Moreover, the extent to which concurrent mental distress (e.g., depression or anxiety), or adverse cognitive processes associated with PSS such as somatosensory amplification, i.e., the dispositional tendency to experience a somatic sensation as intense, harmful, and disturbing [32], predict treatment response, differs across trials [33][34][35][36][37]. Findings on predictors of treatment effects of Internetdelivered CBT (ICBT) are in many ways comparable to those for faceto-face treatments, resembling the heterogenous evidence regarding demographic characteristics such as age or gender, baseline somatic symptom severity, or comorbid mental distress [20,22,[38][39][40][41]. ...
... Assuming a power of 80%, an α-level of 5%, and an expected medium-sized (d = 0.50) between-group effect, based on previous findings [19,20,73], a necessary sample size of 128 participants was calculated beforehand. The actual sample size of 156 thus facilitated the detection of effect sizes of d ≥ 0.45, that is medium to large-sized between-group effects. ...
Article
Objective While studies mainly provide positive evidence for the efficacy of Internet-delivered cognitive-behavioral therapy (ICBT) for various persistent somatic symptoms, it remains largely unclear for whom these interventions work or not. This exploratory analysis aimed to identify moderators for the outcome between ICBT for somatic symptom distress and a waitlist control group (WL) in a vulnerable target group of emerging adults. Methods Based on data from a randomized controlled trial on 156 university students with varying degrees of distressing somatic symptoms who were allocated to either an eight-week, therapist guided ICBT (iSOMA) or to the WL, we examined pretreatment demographic characteristics, health-related variables (e.g., somatic symptom duration), mental distress (e.g., depression, anxiety) and cognitive-emotional factors (emotional reactivity, somatosensory amplification) as candidate moderators of the outcome, somatic symptom distress (assessed by the Patient Health Questionnaire, PHQ-15) from pre- to posttreatment. Results Somatosensory amplification (assessed by the Somatosensory Amplification Scale, SSAS) moderated the outcome in favor of iSOMA (B = −0.17, SE = 0.78, p = .031), i.e., higher pretreatment somatosensory amplification was associated with better outcome in the active compared to the control intervention. No significant moderation effects were found among demographic characteristics, health-related variables, or mental distress. Conclusion Our findings suggest that an Internet-delivered CBT for somatic symptom distress should be preferred over no active treatment particularly in individuals with moderate to high levels of somatosensory amplification, which as a next step should be tested against further active treatments and clinical populations. Trial registration: German Clinical Trials Register (DRKS00014375).
... for the reduction of symptom severity and a large effect size (d=0.84) for the improvement of quality of life (32). Online interventions were especially suited to reduce somatic complaints and improve quality of life (32). ...
... for the improvement of quality of life (32). Online interventions were especially suited to reduce somatic complaints and improve quality of life (32). However, it is to note that several studies do not have adequate control groups, the study population is often very small and blinding often not possible. ...
... Most of the psychological interventions in the treatment of IBS are based on CBT aiming at the reduction of irrational fears and the modulation of behavioral patterns. The NNT with CBT was 4 (95% CI 3-9) (32). However, although CBT shows good results, it is not always available and labor-intensive. ...
Article
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Irritable bowel syndrome (IBS) is a frequent functional gastrointestinal disorder. The patients complain about various symptoms like change in bowel habits, constipation or diarrhea, abdominal pain, and meteorism leading to a great reduction in quality of life. The pathophysiology is complex and best explained using the biopsychosocial model encompassing biological, psychological as well as (psycho)social factors. In line with the multitude of underlying factors, the treatment is comprised of a multitude of components. Often, patients start with lifestyle changes and dietary advice followed by medical treatment. However, also psychotherapy is an important treatment option for patients with IBS and should not be restricted to those with psychiatric comorbidities. Several evidence-based psychotherapeutic treatment options exist such as psychoeducation, self-help, cognitive behavioral therapy, psychodynamic psychotherapy, hypnotherapy, mindfulness-based therapy, and relaxation therapy which will be discussed in the present review.
... To detect an expected medium-sized effect (d ≥ 0.50), based on the range of effects of internet-based self-management interventions in somatic syndromes (e.g., Bernardy et al., 2018;Liegl et al., 2015;Vugts et al., 2018), in an analysis of covariance (ANCOVA) with one covariate, a necessary sample size of N = 128 was calculated, assuming a power of 80% and α-level of 5%. To account for an expected dropout rate of 20%, the target sample size was increased to 154. ...
... Most importantly, iSOMA led to significant improvements on both somatic symptom distress and associated psychobehavioral features of SSD with medium-sized between-group effects and notable rates of reliable change, confirming our primary hypothesis. In comparison, the effect of iSOMA on core aspects of PSS can be considered higher as in studies investigating IBIs in diagnosed, clinical samples with various PSS (Bernardy et al., 2018;Buhrman et al., 2016;Vugts et al., 2018), albeit lower than the effects reported for specific syndromes such as irritable bowel syndrome (Liegl et al., 2015), chronic fatigue syndrome (Janse et al., 2018) or patients with SSD (Newby et al., 2018). This seems reasonable since we did not tailor our intervention to certain somatic symptom clusters or diagnoses, however, we provide evidence for the transsymptomatic efficacy of guided internet-based CBT across a spectrum of physical symptoms. ...
Article
Objective: Persistent somatic symptom distress is common in emerging adults and is associated with adverse health outcomes and impairment. Internet-based interventions could help to prevent burden and chronicity. This randomized controlled trial tested the efficacy of a guided, cognitive-behavioral internet intervention for somatic symptom distress (iSOMA) in emerging adults at risk for somatic symptom disorder compared to a waitlist control condition. Method: 158 participants (N = 156 analyzed; 24.53 years, 83.3% female) with multiple somatic symptoms were recruited among German-speaking universities and randomly allocated to either receive the 8-week iSOMA intervention with psychologist support or the waitlist, both with access to treatment as usual. Primary outcomes were somatic symptom distress Patient Health Questionnaire, somatic symptom scale (PHQ-15) and psychobehavioral features of somatic symptom disorder-12 (SSD-12), assessed at baseline and 8-weeks postrandomization. Secondary outcomes included depression, anxiety, illness worries, functional impairment, and attitudes toward psychological treatment. Results: Participants in the iSOMA group showed significantly greater improvements (ps < .001) in primary outcomes (PHQ-15: d = 0.70 [0.36, 1.05], SSD-12: d = 0.65 [0.30, 0.99], and secondary outcomes (ps < .05; d = 0.41-0.52) compared to the waitlist, except for attitudes toward psychological treatment (p = .944). Satisfaction with iSOMA was high (91.0%), most participants (72.8%) completed at least 4 of 7 modules and negative treatment effects were infrequent (14.9%). Conclusions: Our intervention had a substantial positive impact on somatic symptom distress across a broad range of persistent physical symptoms in a vulnerable target group, opening up promising possibilities for indicative prevention and blended care for somatic symptom disorders. (PsycInfo Database Record (c) 2022 APA, all rights reserved).
... Overall, the NNT for psychological therapies is four patients (95% CI: 3-5) and, therefore, better than the majority of drugs 214 . In a steppedcare approach (begin ning with the least intensive or invasive treatment and stepping up or down depending on the needs of the patients), a psychologybased selfaid (educational) approach has been shown recently in a metaanalysis as an effective treatment option for all subtypes of IBS 250 . Compared with control treatments, a medium effect size was demonstrated on decreased symptom severity and a large effect size on increased patient's QOL. ...
... Relaxation 214 § 6 RCTs (255)• Overall, no benefit of relaxation training or therapy in IBS was detected in the RCTs• The field of studies on relaxation techniques is diverse GSHs250 10 RCTs (886) • Compared with control conditions, a moderate effect size on symptom severity (0.72) and a large effect size on the increase of patients' QOL (0.84) was found• GSHs might be an easily accessible and a cost-effective treatment alternative. However, there is a wide heterogeneity and variance in its performanceThe NNT data are based on Ford et al.214 . ...
Article
Irritable bowel syndrome (IBS) is a functional gastrointestinal disease with a high population prevalence. The disorder can be debilitating in some patients, whereas others may have mild or moderate symptoms. The most important single risk factors are female sex, younger age and preceding gastrointestinal infections. Clinical symptoms of IBS include abdominal pain or discomfort, stool irregularities and bloating, as well as other somatic, visceral and psychiatric comorbidities. Currently, the diagnosis of IBS is based on symptoms and the exclusion of other organic diseases, and therapy includes drug treatment of the predominant symptoms, nutrition and psychotherapy. Although the underlying pathogenesis is far from understood, aetiological factors include increased epithelial hyperpermeability, dysbiosis, inflammation, visceral hypersensitivity, epigenetics and genetics, and altered brain-gut interactions. IBS considerably affects quality of life and imposes a profound burden on patients, physicians and the health-care system. The past decade has seen remarkable progress in our understanding of functional bowel disorders such as IBS that will be summarized in this Primer.
... SHPs were initially developed as a control condition for more manualized therapies, especially in patients with somatoform disorders, such as the IBS (104). As they developed their own theoretical framework, and for economic reasons-providing professional help to more patients outside academic centersmany applications are now available, particularly in combination with web-based approaches (105). ...
Article
Full-text available
The issue of placebo response and the extent of its effect on psychotherapy is complex for two specific reasons: i) Current standards for drug trials, e.g., true placebo interventions, double-blinding, cannot be applied to most psychotherapy techniques, and ii) some of the "nonspecific effects" in drug therapy have very specific effects in psychotherapy, such as the frequency and intensity of patient-therapist interaction. In addition, different psychotherapy approaches share many such specific effects (the "dodo bird verdict") and lack specificity with respect to therapy outcome. Here, we discuss the placebo effect in psychotherapy under four aspects: a) nonspecific factors shared with drug therapy (context factors); b) nonspecific factors shared among all psychotherapy traditions (common factors); c) specific placebo-controlled options with different psychotherapy modalities; and d) nonspecific control options for the specific placebo effect in psychotherapy. The resulting framework proposes that the exploration and enumeration of context factors, common factors, and specific factors contributes to the placebo effects in psychotherapy.
... That is, it is unclear to users of instruments how to equate a score measured on one instrument to a score measured on another instrument. Furthermore, the pooling of study results based on different PROs in systematic reviews and metaanalyses may also be biased [2] [3]. In case of measuring depressive symptom severity, there are more than 100 scales available [4]. ...
Conference Paper
AIMS: There is still little experience with the practical application of common metrics combining different Patient-Reported Outcomes (PROs) on a common scale. Using the example of the well-established depression scale of the Patient Health Questionnaire (PHQ-9), the present study was aimed at examining the performance of a recently published depression metric in independent samples and at comparing different methods of linking scores. METHODS: Using secondary data analysis, we applied a common metric model based on Item-Response Theory (IRT) presented by Wahl et al. (2014) to four German-speaking samples (n=3,315) that completed the PHQ-9. A Confirmatory Factor Analysis (CFA) was conducted in each sample to establish unidimensionality and local independence. We then fitted a Generalized Partial Credit Model (GPCM) with item parameters fixed to the parameters reported for the common depression metric. For each sample as well as for the full sample, we compared resulting parameters to new parameter estimates derived from two different model estimation approaches with unknown item parameters (estimation with shifted prior and Stocking-Lord linking). We investigated the agreement between latent depression scores (theta) resulting from the different estimation methods by fitting a mixed-effects model and using Bland-Altman plots. RESULTS: We found slightly different IRT item parameters across samples and estimation methods. Fixed to a German general population mean of 50 and a standard deviation of 10, the estimated depression score differences between the methods were about Δ=1.0 in the different samples. While these differences were statistically significant, differences between samples were 16 to 130 times larger compared to the observed effects of the linking method. CONCLUSIONS: Using published item parameters from the common depression metric for theta estimation is clinically equivalent to the use of sample-specific item parameter estimates. These findings provide evidence that expected-a-posteriori (EAP) scoring with unconstrained normal prior using a common metric is an appropriate alternative to re-estimation methods. Common metric score estimation is available for researchers at http://www.commonmetrics. org. The application of common metrics is simple and offers a long-term perspective to improve the comparability of PRO measures.
... However, based on the poor performance of one of the no-therapist contact studies, the authors theorized that interventions with no-therapist contact are likely to perform poorly due to a lack of patient engagement in the program. Liegl et al. [18] analyzed ten trials that enrolled 886 patients. The authors described guided self-help (GSH) as a standard psychological intervention that is delivered by any kind of media that the patient can work on independently (e.g., book, website) and can be supported through limited contact with a health care professional (e.g., face-toface, telephone, email). ...
Article
Full-text available
Purpose of review: While dietary and medical treatments are beneficial for specific GI symptoms for some IBS patients, they have an unsatisfactory track record for the full range of GI symptoms for more severe patients. A number of psychological interventions have been developed over the past two decades to help patients' self-manage symptoms. This review discusses the last 5 years of research on psychological treatments, with a focus on cognitive behavioral therapy (CBT) and hypnosis. Recent findings: Recent systematic reviews indicate that psychological interventions are efficacious and their gains are maintained long-term. Treatment gains are not a function of the number of sessions. Psychological interventions are at least moderately efficacious treatments for IBS symptoms. Of different psychotherapies, CBT and hypnosis appear efficacious in minimal-contact formats (e.g., fewer sessions, phone contact). Research is still needed to identify theoretically relevant active ingredients that underlie treatment effects.
... Boersma et al [10] showed in a single-case experimental design in 13 subjects that cognitive behavioral therapy (CBT) for IBS can significantly reduce gastrointestinal symptoms, pain catastrophizing and QOL. Liegl et al [11] believe that guided self-help (GSH) is not only effective but easy to implement. We have demonstrated that the incidence rate of anxiety-related emotional disorders among students suffering from IBS who experienced the Wenchuan earthquake on May 12, 2008, was higher than that among non-IBS students and students unaffected by the earthquake [12]. ...
Article
Full-text available
Background: Stress is a common contributing factor for irritable bowel syndrome (IBS). This study was to evaluate the efficacy of the centralized health education program in improving the quality of life (QOL) of middle school students with IBS who experienced the Wenchuan earthquake on May 12, 2008. Methods: A multi-center, randomized and open evaluation study design was adopted. A total of 584 students who met the Rome III criteria for IBS in four middle schools were identified. Of these students, 29 were excluded for various reasons, and the remaining 555 students were randomly assigned to either the health education group (n = 277) or the control group (n = 278, received no health education). De-identified data were collected via the IBS quality of life (IBS-QOL) questionnaire and abdominal pain was assessed during the 5-year follow-up survey. Results: The IBS-QOL mean total score was comparable at baseline between no-education group and education group no matter in quake-unaffected areas or quake-affected areas (52.27 vs 51.43, t = 1.15, P > 0.05; 51.02 vs 50.64, t = 1.98, P > 0.05). During the 5-year study period, 84 students opted out during follow-up. After 5 years, a significant difference of the IBS-QOL mean total score was observed between the no-education group and education group in quake-unaffected areas (80.53 vs 93.67, t = - 55.45, P < 0.01), which was also observed in quake-affected areas (64.23 vs 93.80, t = - 188.10, P < 0.01). In addition, there was a reciprocal action between factor 1(health education or not) and factor 2(affected by the earthquake or not) regarding IBS-QOL for dysphoria(Q1), interference with activity(Q2), food avoidance(Q5) and relationships(Q8)(P < 0.001) at year 1, 3 and 5. In all students, abdominal pain scores gradually reduced from baseline in each subgroup over 5 years (P < 0.001).The improvement was greater in the education group than in the control group no matter in quake-unaffected area and in quake-affected areas(P < 0.001). There was a reciprocal action between factor 1(health education or not) and factor 2(duration of follow-up) regarding the mean abdominal pain symptom score irrespective of quake-unaffected or quake-affected areas (P = 0.029 and P < 0.001). Conclusion: The health education program improved quality of life and abdominal pain in middle school IBS students in Wenchuan quake-affected areas.
... [32][33][34] Here, the evidence is promising for irritable bowel syndrome (IBS). For example, subgroup analyses of six web-based self-help interventions by Liegl et al 35 In chronic physical conditions, reviews indicate a lower efficacy of IMIs for distress or psychological outcomes than for somatic symptoms. 32 33 Above that, studies investigating IMIs for SSD are scarce: Hedman et al 39 investigated a guided iCBT in a mixed sample including participants with SSD (n=114/86.4%) ...
Article
Full-text available
Introduction: Persistent and distressing somatic symptoms are common in younger age cohorts such as university students. However, the majority does not receive adequate psychosocial care. Internet-based and mobile-based interventions may represent low threshold and effective extensions to reduce somatic and associated mental symptom severity. The planned study aims to investigate the feasibility and efficacy of an internet-based intervention in reducing somatic and psychological symptoms in an international population of university students with somatic symptom burden. Methods and analysis: This parallel two-armed randomised controlled trial evaluates an 8-week guided intervention, including web-based consecutive modules based on cognitive behavioural therapy (CBT) principles against a waitlist control group. Guidance will be provided by trained psychologists with weekly written supportive feedback. As part of the ‘Studicare’ project, the present study aims to recruit n=154 university students indicating somatic symptom burden at baseline in German-speaking universities. Self-report assessments will take place at baseline and after intervention completion (8, 16 weeks after randomisation). The primary outcome will be the severity of somatic symptoms and associated mental distress. Secondary outcomes include depression, (health) anxiety, disability, intervention satisfaction and adherence. Ethics and dissemination: Ethics approval has been granted. Results from this study will be published in peer-reviewed journals and presented at international conferences. Trial registration number DRKS00014375.
... Geführte Selbsthilfemaßnahmen (guided self-help interventions) sind eine Möglichkeit, die Krankheitsbewältigung zu unterstützen [492]. In einer Metaanalyse, die solcheteilweise web-basierte -Selbsthilfemaßnahmen untersuchte, zeigten sich mittlere Effektstärken hinsichtlich Symptomschwere (SMD: 0,72; 95 %-KI: 0,34-1,08) und große Effektstärken hinsichtlich Lebensqualität (SMD: 0,84; 95 %-KI: 0, 22). ...
... different PROs in systematic reviews, and meta-analyses may also be biased [2,3]. In case of measuring depressive symptom severity, there are more than 100 scales available [4]. ...
Article
Objective: To investigate the validity of a common depression metric in independent samples. Study Design and Setting: We applied a common metrics approach based on Item-Response Theory for measuring depression to four German-speaking samples that completed the PHQ-9. We compared the PHQ item parameters reported for this common metric to reestimated item parameters that derived from fitting a Generalized Partial Credit Model solely to the PHQ-9 items. We calibrated the new model on the same scale as the common metric using two approaches (estimation with shifted prior and Stocking-Lord linking). By fitting a mixed-effects model and using Bland-Altman plots, we investigated the agreement between latent depression scores resulting from the different estimation models. Results: We found different item parameters across samples and estimation methods. While differences in latent depression scores between different estimation methods were statistically significant, these were clinically irrelevant. Conclusion: Our findings provide evidence that it is possible to estimate latent depression scores by using the item parameters from a common metric instead of reestimating and linking a model. The use of common metric parameters is simple, for example using a web application (http://www.common-metrics.org), and offers a long-term perspective to improve the comparability of patient-reported outcome measures.
... Bewältigungsstrategien zielen auf die Verbesserung von Selbstfürsorge und Selbstwirksamkeit, verbunden mit der Bearbeitung der Körperwahrnehmung, dem Abbau von Schon-und Vermeidungsverhalten und generell der Verbesserung des Körpererlebens. Belegt ist dabei auch der Einsatz geeigneter Selbsthilfe-Interventionen [82,83]. Bei entsprechender Eignung der Patient*innen scheinen Computer-basierte Interventionen vergleichbar wirksam wie traditionelle Ansätze [84]. ...
... Today, substantial empirical evidence has been considered in treatment guidelines, especially for patients with refractory IBS, who do not respond well to pharmacological treatments 11 ; have major anxiety or depression symptoms; or wish for such treatments. 12,13 Although there is fairly strong empirical evidence regarding the efficacy of different psychological treatments for IBS, [14][15][16][17] the results are mainly based on studies conducted in South America and Europe. Therefore, caution must be taken when generalizing these results to the Iranian population, as cultural differences may affect IBS through different physical (e.g., diet and environmental hygiene), psychological (e.g., disease-related beliefs, anxiety, and somatization), and social (e.g., family systems, food, and digestion-related taboos) factors. ...
Article
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Background: Irritable bowel syndrome (IBS) is a common health problem, with considerable effects on the individual's quality of life, mental health, work productivity, and financial aspects. Psychological interventions, which are commonly used as adjunct treatments, have received fairly strong empirical support. In Iran, several randomized clinical trials (RCTs) have evaluated the efficacy of these treatments; however, the results of these RCTs have not been synthesized yet. Therefore, in this meta-analysis, we aimed to summarize the results of these trials on the efficacy of psychological interventions in Iranian adults with IBS. Methods: We searched IranDoc, ElmNet, PubMed, and Scopus for eligible RCTs. The risk of bias was assessed in each trial, according to the Cochrane guidelines, and the random-effect model was used to pool the effect size (EF) across trials. Results: Twenty RCTs met the eligibility criteria and were included in the meta-analysis. Compared to the controls, the standardized mean difference (SMD) for psychological interventions was large regarding the severity of IBS symptoms (-1.21; 95% CI: -1.63 to -0.80), anxiety (-0.97; 95% CI: -1.32 to -0.63), and depression (-0.86; 95% CI: -1.28 to -0.44). There was considerable heterogeneity among the included RCTs regarding all three outcomes, which could not be explained by the available information. On the other hand, the EF of health-related quality of life was 0.64 (95% CI: 0.38 to 0.85), with no significant heterogeneity among RCTs. Conclusion: The existing evidence suggests that psychological interventions can be highly effective in improving the severity of IBS symptoms, mental health, and quality of life for Iranian adults with IBS. However, some weaknesses should be considered in the interpretation of the results and future research. The risk of randomization was high or unclear in almost all of the existing trials; there was no single large trial in this area; and there was substantial inconsistency in the EFs, which might be related to methodological or clinical moderators.
... Disease self-management programs are rooted in the belief that self-efficacy, or confidence in one's ability to manage one's health, is critical to improving GI symptoms, psychological symptoms, extraintestinal symptoms, and health-related quality of life in patients with DGBIs. [7][8][9][10][11] Many of these programs can be delivered in the form of self-help workbooks. 10,12 Self-management training can contribute to a reduction of disease-related anxiety and correction of common misconceptions about DGBIs, and to increased awareness of common symptom triggers, such as diet, stress, and physical activity, which can lead to improved selfconfidence, self-care, and hope. ...
Article
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Background and Aims This Rome Foundation Working Team Report reflects the consensus of an international, interdisciplinary team of experts regarding the use of behavioral interventions in patients with disorders of gut-brain interaction (DGBI), specifically Brain-Gut Behavior Therapies (BGBT). Methods The committee members reviewed the extant scientific literature and whenever possible, addressed gaps in this literature through the lens of their clinical and scientific expertise. Delphi method was used to create consensus on the goals, structure and framework before writing the report. The report is broken into five parts: 1) Definition and evidence for Brain-Gut Behavior Therapies (BGBT); 2) The Gut-Brain Axis as the mechanistic basis for BGBT; 3) Targets of Brain-Gut Behavior Therapies; 4) Common and Unique Therapeutic techniques seen in BGBT; and 5) Who and How to Refer for BGBT Conclusions We chose to not only review for the reader the 5 existing classes of BGBT and their evidence, but to connect DGBI-specific behavioral targets and techniques as they relate directly, or in some cases indirectly, to the Gut-Brain-Axis. In doing so, we expect to increase GI providers’ confidence in identifying and referring appropriate candidates for BGBT and also support clinical decision making for mental health professionals providing BGBT. Both gastrointestinal medical providers and behavioral health providers have an opportunity to optimize care for DGBI through a collaborative, integrated approach that begins with an effective patient-provider relationship, thoughtful communication about the brain-gut-axis and, when appropriate, a well-communicated referral to BGBT.
... Geführte Selbsthilfemaßnahmen (guided self-help interventions) sind eine Möglichkeit, die Krankheitsbewältigung zu unterstützen [492]. In einer Metaanalyse, die solcheteilweise web-basierte -Selbsthilfemaßnahmen untersuchte, zeigten sich mittlere Effektstärken hinsichtlich Symptomschwere (SMD: 0,72; 95 %-KI: 0,34-1,08) und große Effektstärken hinsichtlich Lebensqualität ( S M D :0 , 8 4 ;9 5% -K I :0 , 4 6 -1,22). ...
... 30 Among patients with IBS, GSH interventions have been associated with decreases in symptom severity and increases in quality of life. 29 Our GSH intervention was developed by our clinical experts in CSS and chronic abdominal pain and translated our contemporary understanding of these conditions. The pilot allowed us to capture feedback from patients to improve and clarify module content to enhance understanding. ...
Article
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Objective To design and evaluate, through a human-centered design approach, a multispeciality clinic for patients with central sensitization syndromes that combined virtual previsit consultations, traditional face-to-face appointments, and technology-enabled educational programming. Patients and Methods Patients with suspected fibromyalgia and chronic abdominal pain were seen in a multispecialty practice, and the performance of the clinic was evaluated against a contemporary cohort. Quantitative and qualitative evaluation measures included team estimates of time spent on care-related tasks, physician rank of alignment of patient need with clinic design, major appointment changes, and nonvisit care tasks. Members of the care team also evaluated strengths, weaknesses, opportunities, and threats to the success of the clinic. Results The pilot clinic was operated from April 1, 2020, to April 30, 2021, and included 34 patients with suspected fibromyalgia/chronic abdominal pain. During the pilot period, physicians ranked the value of the virtual previsit consultations in providing care as 7.5 on a scale of 0 to 10 and reported an average of 50 minutes in preparation for the appointment, execution of the appointment, and postvisit documentation. We did not observe substantial differences in the number of added appointments or messages received within the patient portal when compared with a comparison cohort. Patients who participated in the combination nurse educator–led and digital education program provided positive feedback about their experience. Conclusion Our clinic model provides a framework for the treatment of patients with debilitating centrally sensitized conditions and future expansion of virtual care delivery models to better meet patient care and educational needs.
Thesis
Deutsch: (English Version below): Das Konzept der Selbstwirksamkeit ist zentral in der Behandlung von PatientInnen und KlientInnen. Innerhalb der Psychologie wurden unterschiedliche Selbstwirksamkeitsmodelle erstellt. Diese werden im ersten Schritt beschrieben und dann kritisch miteinander verglichen. Diese Modelle aus der Psychologie werden danach mit den Konzepten der Integrativen Therapie verglichen. Dabei stehen die Heilfaktoren und das Vierstufenmodell der Integrativen Therapie im Zentrum der Betrachtung. Anschließend werden im empirischen Teil mehrere unterschiedliche Fragebögen und Konzepte von Selbstwirksamkeit und intentionalem Verhalten in ihrem Vorhersagewert für die Wirksamkeit einer multimodalen Behandlung von PatientInnen mit somatischer Belastungsstörung und chronischen Rückenschmerzen getestet. In mehreren Studien konnte bereits gezeigt werden, dass die Selbstwirksamkeit und die Motivation der PatientInnen an der Behandlung teilzunehmen, einen Einfluss auf die Wirksamkeit haben. Um den Einfluss auf die Wirksamkeit in Bezug auf Schmerzstärke und allgemeines Wohlbefinden zu erforschen, wurden 136 PatientInnen, die unter anderem an chronischen Rückenschmerzen und einer somatischen Belastungsstörung litten, in einer allgemeinen Rehabilitation im Moorheilbad Harbach behandelt. Vor und nach der Behandlung wurden die Schmerzintensität, allgemeines Wohlbefinden, verschiedene Selbstwirksamkeitsskalen sowie ein Fragebogen zur Messung der Intention an der Behandlung teilzunehmen, erhoben. Die teilnehmenden PatientInnen profitierten stark durch die Teilnahme am Programm. Es zeigte sich eine Zunahme im allgemeinen Wohlbefinden, eine Reduktion der derzeitigen Schmerzen und der Schmerzen während der Behandlung im Vergleich zu jenen vor der Behandlung. Die Veränderung des allgemeinen Wohlbefindens kann durch die allgemeine Selbstwirksamkeit (SWE) vorhergesagt werden. Die Veränderungen im derzeitigen Schmerz werden am besten durch die schmerzspezifische Selbstwirksamkeit prognostiziert. ENGLISH ABSTRACT: The concept of self-efficacy is central in the treatment of patients and clients. Within psychology different models of self-efficacy have been developed, which will be described and critically discussed in the first part of this thesis. The psychological models will then be compared to concepts of self-efficacy in Integrative Psychotherapy. The seven healing-factors and the four-level-model are most central in Integrative Therapy for the discussion of self-efficacy. In the empirical part different self-assessment questionnaires evaluating self-efficacy and intentionality were used to predict the treatment outcome of a multimodal therapy for patients with somatic symptom disorder and chronic back-pain. Previous studies showed that patients‘ self-efficacy and motivation beliefs influence treatment outcome. To evaluate the effect of these beliefs in relation to pain intensity and general well-being 136 patients with chronic backpain and somatic symptom disorder were included in this study. Before and after the treatment at the health and rehabilitation centre Moorheilbad Harbach pain intensity, general well-being, and patients‘ intention to participate in all treatments were measured. Patients benefited from participation in the treatment. General well-being increased and pain intensity decreased in comparison of pre- and post-enquiry values. Changes in general well-being can be predicted based on general self-efficacy beliefs of the patients; changes in current pain intensity can be predicted based on self-efficacy beliefs to cope with pain.
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Computer-based interventions target improvement of physical and emotional functioning in patients with chronic pain and functional somatic syndromes. However, it is unclear to what extent which interventions work and for whom. This systematic review and meta-analysis (registered at PROSPERO, 2016: CRD42016050839) assesses efficacy relative to passive and active control conditions, and explores patient and intervention factors. Controlled studies were identified from MEDLINE, EMBASE, PsychInfo, Web of Science, and Cochrane Library. Pooled standardized mean differences by comparison type, and somatic symptom, health-related quality of life, functional interference, catastrophizing, and depression outcomes were calculated at post-treatment and at 6 or more months follow-up. Risk of bias was assessed. Sub-group analyses were performed by patient and intervention characteristics when heterogeneous outcomes were observed. Maximally, 30 out of 46 eligible studies and 3,387 participants were included per meta-analysis. Mostly, internet-based cognitive behavioral therapies were identified. Significantly higher patient reported outcomes were found in comparisons with passive control groups (standardized mean differences ranged between -.41 and -.18), but not in comparisons with active control groups (SMD = -.26 - -.14). For some outcomes, significant heterogeneity related to patient and intervention characteristics. To conclude, there is a minority of good quality evidence for small positive average effects of computer-based (cognitive) behavior change interventions, similar to traditional modes. These effects may be sustainable. Indications were found as of which interventions work better or more consistently across outcomes for which patients. Future process analyses are recommended in the aim of better understanding individual chances of clinically relevant outcomes.
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Functional somatic syndromes (FSS), like irritable bowel syndrome or fibromyalgia and other symptoms reflecting bodily distress, are common in practically all areas of medicine worldwide. Diagnostic and therapeutic approaches to these symptoms and syndromes vary substantially across and within medical specialties from biomedicine to psychiatry. Patients may become frustrated with the lack of effective treatment, doctors may experience these disorders as difficult to treat, and this type of health problem forms an important component of the global burden of disease. This review intends to develop a unifying perspective on the understanding and management of FSS and bodily distress. Firstly, we present the clinical problem and review current concepts for classification. Secondly, we propose an integrated etiological model which encompasses a wide range of biopsychosocial vulnerability and triggering factors and considers consecutive aggravating and maintaining factors. Thirdly, we systematically scrutinize the current evidence base in terms of an umbrella review of systematic reviews from 2007 to 2017 and give recommendations for treatment for all levels of care, concentrating on developments over the last 10 years. We conclude that activating, patient-involving, and centrally acting therapies appear to be more effective than passive ones that primarily act on peripheral physiology, and we recommend stepped care approaches that translate a truly biopsychosocial approach into actual management of the patient.
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Pain relief remains a significant challenge in the management of irritable bowel syndrome (IBS): “Does anything really help relieve the pain in patients with IBS?”. Interventions aimed at pain relief in patients with IBS include diet, probiotics or antibiotics, antidepressants, antispasmodics, and drugs targeting specific gastrointestinal receptors such as opioid or histamine receptors. In the systematic review and meta-analysis published in this journal, Lambarth et al. examined the literature on the role of oral and parenteral anti-neuropathic agents in the management of pain in patients with IBS. This review article appraises their assessment of the efficacy of the anti-neuropathic agents amitriptyline, pregabalin, gabapentin, and duloxetine in the relief of abdominal pain or discomfort, and impact on overall IBS severity and quality of life. This commentary provides an update of current evidence on the efficacy of the dietary and pharmacological treatments that are available or in development, as well psychological and cognitive behavioral therapy for pain in IBS. Advances in recent years augur well for efficacious treatments that may expand the therapeutic arsenal for pain in IBS.
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In psychiatry, comparative analyses of therapeutic options and the aggregation of data from clinical trials across different therapeutic approaches play an important role in clinical decision making, treatment guidelines, and health policy. This approach assumes that trials of pharmacological and behavioural therapies generally produce the same level of evidence when properly designed. However, trial design for behavioural interventions has some unique characteristics and control groups vary widely, which influence the effects observed in any given trial. In this Personal View, we review various control conditions typically used in psychiatry, outline their effect on the internal validity and expected effect size of a trial, and propose a decision framework for choosing a control condition depending on the risk to the patient population and the stage of development of the therapeutic intervention. We argue that the choice of control group and its justification need to be taken into consideration when comparing behavioural and pharmacological therapies.
Article
Nichtmedikamentöse Therapien des Reizdarmsyndroms (RDS) sind angesichts der wenigen zur Verfügung stehenden Medikamente vermutlich häufig im Gebrauch. Darunter werden hier Ernährungstherapien, Psychotherapien und viele komplementärmedizinische Ansätze verstanden. Bei den Ernährungstherapien spielen v. a. Ballaststoffsupplementierungen und Nahrungsergänzungen durch Probiotika sowie Diäten mit einem niedrigen Anteil an schnell fermentierbaren Zuckern (sog. FOFMAP) eine Rolle. Bei den Psychotherapien sind es die traditionellen verhaltenstherapeutischen und psychodynamischen Ansätze, die darmbezogene Hypnotherapie, Entspannungstherapien, Achtsamkeitstraining und Selbsthilfeprogramme. Bei der Komplementärmedizin steht v. a. die Akupunktur im Vordergrund. Zusammengefasst lässt sich festhalten, dass die Wirksamkeit der Ballaststofftherapie beim RDS nicht nachgewiesen ist, dass nur einzelne probiotische Präparate eine Wirksamkeit beim RDS haben und dass die langfristige Effizienz der Low-FODMAP-Diäten noch gezeigt werden muss. Für die Psychotherapien ist bei der kognitiven Verhaltenstherapie und bei der darmbezogenen Hypnotherapie die Wirksamkeit unbestritten, während für psychodynamische Ansätze zu wenige Studien vorliegen. Die Entspannungstherapie ist beim RDS unwirksam, aber das Achtsamkeitstraining hat therapeutisches Potenzial und Selbsthilfeprogramme sind eine kostengünstige Alternative zu Psychotherapien. Für keines der komplementärmedizinischen Verfahren liegt dagegen eine überzeugende Evidenz der Wirksamkeit vor.
Article
Up to 30% of the population in Western countries suffer from chronic pain. The treatment of chronic pain causes medical and socioeconomic problems. Guided self-help (GSH) might be an effective supplementary treatment, however, the size of this effect is unclear. This meta-analysis quantifies the effect of GSH on chronic pain. A systematic literature search was conducted using PubMed, Cochrane, Psyndex, Psycinfo and Scopus. Studies that investigated GSH in chronic pain conditions (children and adults) were included. Disability, quality of life and pain severity were defined as main outcomes. We conducted random effects models to calculate standardized mean differences (SMDs). By applying mixed models and subgroup analyses, we examined the moderating effects of sample characteristics (age; pain region), GSH format (online; face-to-face contact) and study characteristics (study quality; control condition). We identified 16 eligible studies, including 739 subjects. Between-group analyses resulted in a medium, but heterogeneous effect size for pain severity (SMD = 0.51; CI95: 0.21, 0.81). After excluding two samples suggesting small study bias, the effect on pain severity was small but homogeneous (SMD = 0.34; CI95: 0.13, 0.54). We found a small effect size for disability (SMD = 0.30; CI95: 0.10, 0.50). The pooled effect size for quality of life did not reach significance (SMD = 0.24; CI95: −0.07, 0.54). We conclude that GSH has a small but robust effect on pain severity and disability in chronic pain patients. This applies to various GSH formats and patient populations. It seems reasonable to integrate GSH into clinical practice as a supplemental treatment option.
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Background: Item response theory (IRT) methods are increasingly used to standardize the assessment of patient- reported outcomes. By estimating an IRT model with a large number of items measuring the same trait, a construct-based item bank can be established. In theory, any subset of relevant items for a specific population can be selected from an IRT-calibrated item bank to assess an individual’s trait level on a standardized scale. However, health-related constructs, such as physical functioning or depression, are often broadly defined, and items of the same item bank may differ in corresponding subdomain or item format, potentially affecting construct validity if different subsets are used for measuring the same latent trait. Based on three studies on recently established item banks, this thesis aims to investigate if different item subsets sufficiently represent the latent construct defined by an entire item bank. Methods: Study 1: Data from N=3,315 German-speaking subjects who answered the Patient Health Questionnaire depression scale (PHQ-9) were analyzed. For estimating depression scores, PHQ-9 item parameters were used as reported for an IRT-calibrated depression item bank consisting of 143 items from 11 questionnaires in an earlier study. These scores were compared to newly estimated scores resulting from fitting an IRT model solely to the PHQ-9 data. Study 2: The German 121-item PROMIS Physical Function item bank covering different subdomains was psychometrically tested (N=266). Nonparametric IRT and factor analysis were used to evaluate scalability and unidimensionality. Study 3: PROMIS Wave 1 data (N=15,719 subjects from the US) were used to compare measurement precision between three PROMIS Physical Function short forms with similar content but different item format. A common IRT model was estimated for these short forms. Unidimensionality was evaluated using one-factor and bifactor models. Results: Study 1: Reestimating the model solely based on PHQ-9 data led to similar depression scores compared to using item bank parameters for scoring. Study 2: The PROMIS Physical Function item bank showed sufficient psychometric properties, including unidimensionality. Scores based on different (subdomain-specific) item subsets were highly correlated with the full item bank. Study 3: The item format affected measurement precision and range but not the underlying construct. Conclusion: These findings indicate construct validity of using item subsets from large IRT-calibrated item banks for the assessment of patient-reported outcomes. This applies even when the item subsets vary in subdomain-specific content or item format, enabling high flexibility regarding the use of tailored (e.g., population-specific) measurement tools.
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Functional gastrointestinal disorders (FGID), including irritable bowel syndrome, functional dyspepsia and functional abdominal pain, are common in adolescents and are associated with substantially decreased quality of life. Cognitive behavior therapy for children and adolescents with FGID is one of few treatments that have shown effect, but treatment access is limited. In adults with irritable bowel syndrome, exposure-based internet-delivered CBT (ICBT) leads to reduced symptoms and increased quality of life, but studies in children are lacking. This open pilot aimed to evaluate feasibility and the potential efficacy of an exposure-based ICBT-program for adolescents with pain-predominant FGID. Twenty-nine adolescents (age 13–17), with FGID were included. The ICBT-program lasted for 8 weeks with weekly online therapist support. The protocol for adolescents included exposure to abdominal symptoms, while the protocol for parents aimed at increasing parents' attention to adolescent healthy behaviors. Assessment points were baseline, post-treatment and 6-month follow-up. The primary outcome was the Gastrointestinal Symptoms Rating Scale-IBS (GSRS-IBS). Effect sizes were calculated using Cohen's d in an intent to treat analysis. GSRS-IBS improved significantly from baseline to post-treatment (mean difference 6.48; 95% CI [2.37–10.58]) and to follow-up (mean difference 7.82; 95% CI [3.43–12.21]), corresponding to moderate effect sizes (within-group Cohen's d = 0.50; 95% CI [0.16–0.84] and d = 0.63; 95% CI [0.24–1.02], respectively). Treatment adherence was high with 22 of 29 (76%) adolescents completing the entire treatment period. High adherence indicates acceptability of format and content, while symptomatic improvement suggests potential efficacy for this ICBT intervention in adolescents with FGID.
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Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.
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Therapist-guided internet-based cognitive behavior therapy (ICBT) has been tested in numerous controlled trials conducted in research settings. It is now established that this novel treatment format works for a range of clinical conditions. It is less well known if the promising results from efficacy studies can be transferred to routine clinical practice. In this paper we review the evidence from effectiveness studies and highlight challenges when implementing ICBT. Following literature searches we identified 4 controlled trials and 8 open studies, involving a total of 3,888 patients. There is now an increasing number of effectiveness studies on ICBT with studies on panic disorder, social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder, depression, tinnitus, and irritable bowel syndrome. All indicate that it is possible to transfer ICBT to clinical practice with sustained effects and moderate to large effect sizes. However, it is not clear which model to use for service delivery, and more work remains to be done on dissemination of ICBT. Moreover, the knowledge about outcome predictors from controlled efficacy trials is probably less relevant, and studies with large clinically representative samples are needed to investigate for which patients ICBT is suitable. In this work existing data could be combined and reanalyzed to study predictors of outcome.
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New strategies for the care of irritable bowel syndrome (IBS) are developing and several novel treatments have been globally produced. New methods of care should be customized geographically because each country has a specific medical system, life style, eating habit, gut microbiota, genes and so on. Several clinical guidelines for IBS have been proposed and the Japanese Society of Gastroenterology (JSGE) subsequently developed evidence-based clinical practice guidelines for IBS. Sixty-two clinical questions (CQs) comprising 1 definition, 6 epidemiology, 6 pathophysiology, 10 diagnosis, 30 treatment, 4 prognosis, and 5 complications were proposed and statements were made to answer to CQs. A diagnosis algorithm and a three-step treatment was provided for patients with chronic abdominal pain or abdominal discomfort and/or abnormal bowel movement. If more than one alarm symptom/sign, risk factor and/or routine examination is positive, colonoscopy is indicated. If all of them, or the subsequent colonoscopy, are/is negative, Rome III or compatible criteria is applied. After IBS diagnosis, step 1 therapy consisting of diet therapy, behavioral modification and gut-targeted pharmacotherapy is indicated for four weeks. Non-responders to step 1 therapy proceed to the second step that includes psychopharmacological agents and simple psychotherapy for four weeks. In the third step, for patients non-responsive to step 2 therapy, a combination of gut-targeted pharmacotherapy, psychopharmacological treatments and/or specific psychotherapy is/are indicated. Clinical guidelines and consensus for IBS treatment in Japan are well suited for Japanese IBS patients; as such, they may provide useful insight for IBS treatment in other countries around the world.
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Objectives: Irritable bowel syndrome (IBS) and chronic idiopathic constipation (CIC) are functional bowel disorders. Evidence suggests that disturbance in the gastrointestinal microbiota may be implicated in both conditions. We performed a systematic review and meta-analysis to examine the efficacy of prebiotics, probiotics, and synbiotics in IBS and CIC. Methods: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were searched (up to December 2013). Randomized controlled trials (RCTs) recruiting adults with IBS or CIC, which compared prebiotics, probiotics, or synbiotics with placebo or no therapy, were eligible. Dichotomous symptom data were pooled to obtain a relative risk (RR) of remaining symptomatic after therapy, with a 95% confidence interval (CI). Continuous data were pooled using a standardized or weighted mean difference with a 95% CI. Results: The search strategy identified 3,216 citations. Forty-three RCTs were eligible for inclusion. The RR of IBS symptoms persisting with probiotics vs. placebo was 0.79 (95% CI 0.70-0.89). Probiotics had beneficial effects on global IBS, abdominal pain, bloating, and flatulence scores. Data for prebiotics and synbiotics in IBS were sparse. Probiotics appeared to have beneficial effects in CIC (mean increase in number of stools per week=1.49; 95% CI=1.02-1.96), but there were only two RCTs. Synbiotics also appeared beneficial (RR of failure to respond to therapy=0.78; 95% CI 0.67-0.92). Again, trials for prebiotics were few in number, and no definite conclusions could be drawn. Conclusions: Probiotics are effective treatments for IBS, although which individual species and strains are the most beneficial remains unclear. Further evidence is required before the role of prebiotics or synbiotics in IBS is known. The efficacy of all three therapies in CIC is also uncertain.
Article
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Functional gastrointestinal disorders (FGID), including irritable bowel syndrome, functional dyspepsia and functional abdominal pain, are common in adolescents and are associated with substantially decreased quality of life. Cognitive behavior therapy for children and adolescents with FGID is one of few treatments that have shown effect, but treatment access is limited. In adults with irritable bowel syndrome, exposure-based internet-delivered CBT (ICBT) leads to reduced symptoms and increased quality of life, but studies in children are lacking. This open pilot aimed to evaluate feasibility and the potential efficacy of an exposure-based ICBT-program for adolescents with pain-predominant FGID. Twenty-nine adolescents (age 13–17), with FGID were included. The ICBT-program lasted for 8 weeks with weekly online therapist support. The protocol for adolescents targeted exposure to abdominal symptoms, while the protocol for parents was aimed at increasing parents' attention to adolescent healthy behaviors. Assessment points were baseline, post-treatment and 6-month follow-up. The primary outcome was the Gastrointestinal Symptoms Rating Scale-IBS (GSRS-IBS). Effect sizes were calculated using Cohen's d in an intent to treat analysis. GSRS-IBS improved significantly from baseline to post-treatment (mean difference − 6.48; 95% CI [2.37–10.58]) and to follow-up (mean difference − 7.82; 95% CI [3.43–12.21]), corresponding to moderate effect sizes (within-group Cohen's d = 0.50; 95% CI [0.16–0.84] and d = 0.63; 95% CI [0.24–1.02], respectively). Treatment adherence was high with 22 of 29 (76%) adolescents completing the entire treatment period. High adherence indicates acceptability of format and content, while symptomatic improvement suggests potential efficacy for this ICBT intervention in adolescents with FGID.
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Objectives: Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder. Evidence relating to the treatment of this condition with antidepressants and psychological therapies continues to accumulate. Methods: We performed an updated systematic review and meta-analysis of randomized controlled trials (RCTs). MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were searched (up to December 2013). Trials recruiting adults with IBS, which compared antidepressants with placebo, or psychological therapies with control therapy or "usual management," were eligible. Dichotomous symptom data were pooled to obtain a relative risk (RR) of remaining symptomatic after therapy, with a 95% confidence interval (CI). Results: The search strategy identified 3,788 citations. Forty-eight RCTs were eligible for inclusion: thirty-one compared psychological therapies with control therapy or "usual management," sixteen compared antidepressants with placebo, and one compared both psychological therapy and antidepressants with placebo. Ten of the trials of psychological therapies, and four of the RCTs of antidepressants, had been published since our previous meta-analysis. The RR of IBS symptom not improving with antidepressants vs. placebo was 0.67 (95% CI=0.58-0.77), with similar treatment effects for both tricyclic antidepressants and selective serotonin reuptake inhibitors. The RR of symptoms not improving with psychological therapies was 0.68 (95% CI=0.61-0.76). Cognitive behavioral therapy, hypnotherapy, multicomponent psychological therapy, and dynamic psychotherapy were all beneficial. Conclusions: Antidepressants and some psychological therapies are effective treatments for IBS. Despite the considerable number of studies published in the intervening 5 years since we last examined this issue, the overall summary estimates of treatment effect have remained remarkably stable.
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Introduction Irritable bowel syndrome (IBS) is characterised by symptoms such as abdominal pain, constipation, diarrhoea and bloating. These symptoms impact on health-related quality of life, result in excess service utilisation and are a significant burden to healthcare systems. Certain mechanisms which underpin IBS can be explained by a biopsychosocial model which is amenable to psychological treatment using techniques such as cognitive behavioural therapy (CBT). While current evidence supports CBT interventions for this group of patients, access to these treatments within the UK healthcare system remains problematic. Methods and analysis A mixed methods feasibility randomised controlled trial will be used to assess the feasibility of a low-intensity, nurse-delivered guided self-help intervention within secondary care gastrointestinal clinics. A total of 60 participants will be allocated across four treatment conditions consisting of: high-intensity CBT delivered by a fully qualified cognitive behavioural therapist, low-intensity guided self-help delivered by a registered nurse, self-help only without therapist support and a treatment as usual control condition. Participants from each of the intervention arms of the study will be interviewed in order to identify potential barriers and facilitators to the implementation of CBT interventions within clinical practice settings. Quantitative data will be analysed using descriptive statistics only. Qualitative data will be analysed using a group thematic analysis. Ethics and dissemination This study will provide essential information regarding the feasibility of nurse-delivered CBT interventions within secondary care gastrointestinal clinics. The data gathered during this study would also provide useful information when planning a substantive trial and will assist funding bodies when considering investment in substantive trial funding. A favourable opinion for this research was granted by the Nottingham 2 Research Ethics Committee. Trial registration number ISRCTN: 83683687 (http://www.controlled-trials.com/ISRCTN83683687).
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Background: Irritable bowel syndrome (IBS) and functional abdominal pain (syndrome) (FAP(S)) are common pediatric disorders, characterized by chronic or recurrent abdominal pain. Treatment is challenging, especially in children with persisting symptoms. Gut-directed hypnotherapy (HT) performed by a therapist has been shown to be effective in these children, but is still unavailable to many children due to costs, a lack of qualified child-hypnotherapists and because it requires a significant investment of time by child and parent(s). Home-based hypnotherapy by means of exercises on CD has been shown effective as well, and has potential benefits, such as lower costs and less time investment. The aim of this randomized controlled trial (RCT) is to compare cost-effectiveness of individual HT performed by a qualified therapist with HT by means of CD recorded self-exercises at home in children with IBS or FAP(S). Methods/design: 260 children, aged 8-18 years with IBS or FAP(S) according to Rome III criteria are included in this currently conducted RCT with a follow-up period of one year. Children are randomized to either 6 sessions of individual HT given by a qualified therapist over a 3-month period or HT through self-exercises at home with CD for 3 months.The primary outcome is the proportion of patients in which treatment is successful at the end of treatment and after one year follow-up. Treatment success is defined as at least 50% reduction in both abdominal pain frequency and intensity scores. Secondary outcomes include adequate relief, cost-effectiveness and effects of both therapies on depression and anxiety scores, somatization scores, QoL, pain beliefs and coping strategies. Discussion: If the effectiveness of home-based HT with CD is comparable to, or only slightly lower, than HT by a therapist, this treatment may become an attractive form of therapy in children with IBS or FAP(S), because of its low costs and direct availability. Trial registration: Dutch Trial Register number NTR2725 (date of registration: 1 February 2011).
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Background: Chronic pain (i.e. pain lasting longer than three months) is common. Psychological therapies (e.g. cognitive behavioural therapy) can help people to cope with pain, depression and disability that can occur with such pain. Treatments currently are delivered via hospital out-patient consultation (face-to-face) or more recently through the Internet. This review looks at the evidence for psychological therapies delivered via the Internet for adults with chronic pain. Objectives: Our objective was to evaluate whether Internet-delivered psychological therapies improve pain symptoms, reduce disability, and improve depression and anxiety for adults with chronic pain. Secondary outcomes included satisfaction with treatment/treatment acceptability and quality of life. Search methods: We searched CENTRAL (Cochrane Library), MEDLINE, EMBASE and PsycINFO from inception to November 2013 for randomised controlled trials (RCTs) investigating psychological therapies delivered via the Internet to adults with a chronic pain condition. Potential RCTs were also identified from reference lists of included studies and relevant review articles. In addition, RCTs were also searched for in trial registries. Selection criteria: Peer-reviewed RCTs were identified and read in full for inclusion. We included studies if they used the Internet to deliver the primary therapy, contained sufficient psychotherapeutic content, and promoted self-management of chronic pain. Studies were excluded if the number of participants in any arm of the trial was less than 20 at the point of extraction. Data collection and analysis: Fifteen studies met the inclusion criteria and data were extracted. Risk of bias assessments were conducted for all included studies. We categorised studies by condition (headache or non-headache conditions). Four primary outcomes; pain symptoms, disability, depression, and anxiety, and two secondary outcomes; satisfaction/acceptability and quality of life were extracted for each study immediately post-treatment and at follow-up (defined as 3 to 12 months post-treatment). Main results: Fifteen studies (N= 2012) were included in analyses. We assessed the risk of bias for included studies as low overall. We identified nine high 'risk of bias' assessments, 22 unclear, and 59 low 'risk of bias' assessments. Most judgements of a high risk of bias were due to inadequate reporting.Analyses revealed seven effects. Participants with headache conditions receiving psychological therapies delivered via the Internet had reduced pain (number needed to treat to benefit = 2.72, risk ratio 7.28, 95% confidence interval (CI) 2.67 to 19.84, p < 0.01) and a moderate effect was found for disability post-treatment (standardised mean difference (SMD) ‒0.65, 95% CI ‒0.91 to ‒0.39, p < 0.01). However, only two studies could be entered into each analysis; hence, findings should be interpreted with caution. There was no clear evidence that psychological therapies improved depression or anxiety post-treatment (SMD -0.26, 95% CI -0.87 to 0.36, p > 0.05; SMD -0.48, 95% CI -1.22 to 0.27, p > 0.05), respectively. In participants with non-headache conditions, psychological therapies improved pain post-treatment (p < 0.01) with a small effect size (SMD -0.37, 95% CI -0.59 to -0.15), disability post-treatment (p < 0.01) with a moderate effect size (SMD -0.50, 95% CI -0.79 to -0.20), and disability at follow-up (p < 0.05) with a small effect size (SMD -0.15, 95% CI -0.28 to -0.01). However, the follow-up analysis included only two studies and should be interpreted with caution. A small effect was found for depression and anxiety post-treatment (SMD -0.19, 95% CI -0.35 to -0.04, p < 0.05; SMD -0.28, 95% CI -0.49 to -0.06, p < 0.01), respectively. No clear evidence of benefit was found for other follow-up analyses. Analyses of adverse effects were not possible.No data were presented on satisfaction/acceptability. Only one study could be included in an analysis of the effect of psychological therapies on quality of life in participants with headache conditions; hence, no analysis could be undertaken. Three studies presented quality of life data for participants with non-headache conditions; however, no clear evidence of benefit was found (SMD -0.27, 95% CI -0.54 to 0.01, p > 0.05). Authors' conclusions: There is insufficient evidence to make conclusions regarding the efficacy of psychological therapies delivered via the Internet in participants with headache conditions. Psychological therapies reduced pain and disability post-treatment; however, no clear evidence of benefit was found for depression and anxiety. For participants with non-headache conditions, psychological therapies delivered via the Internet reduced pain, disability, depression, and anxiety post-treatment. The positive effects on disability were maintained at follow-up. These effects are promising, but considerable uncertainty remains around the estimates of effect. These results come from a small number of trials, with mostly wait-list controls, no reports of adverse events, and non-clinical recruitment methods. Due to the novel method of delivery, the satisfaction and acceptability of these therapies should be explored in this population. These results are similar to those of reviews of traditional face-to-face therapies for chronic pain.
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Psychological distress, depression and anxiety are common in most physical diseases, and self-help interventions, if effective, might be an important approach to improve outcomes as they are inexpensive to provide to large numbers of patients. The primary aim of this review was to assess randomised controlled trials examining the impact of self-help interventions on symptoms of depression, anxiety and psychological distress in patients with physical illness. Systematic searches of electronic databases resulted in twenty-five eligible studies for meta-analysis (N = 4,211). The results of the primary meta-analyses revealed a significant improvement in depression symptoms, in favour of the intervention group (SMD = -0.13, 95% CI: -0.25, -0.02, p = 0.02, I2 = 50%). There were no significant differences in symptoms of anxiety (SMD = -0.10, 95% CI: -0.24, 0.05, p = 0.20, I2 = 63%) or psychological distress (SMD = -0.14, 95% CI: -0.40, 0.12, p = 0.30, I2 = 72%) between intervention and control conditions. Several subgroup and sensitivity analyses improved effect sizes, suggesting that optimal mental health outcomes may be obtained in patients without neurological conditions, and with interventions based on a therapeutic model (such as cognitive behavioural therapy), and with stress management components. This review demonstrates that with appropriate design and implementation, self-help interventions may potentially improve symptoms of depression in patients with physical conditions.
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This integrative literature review explores the utility of telehealth, specifically videoconferencing, for the delivery of cognitive-behavioral therapy (CBT) to youth with functional abdominal pain (FAP). Children with FAP and their families encounter a number of barriers to treatment that hinder access to traditional in-clinic treatments, such as CBT. Videoconferencing may be a feasible and effective alternative to traditional services and may hold benefits such as high rates of patient satisfaction, improved access to care, improved attendance rates, and cost reductions to the family. This article concludes that videoconferencing provides a good "fit" with the delivery of CBT to children and adolescents with FAP.
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Background No consensus exists on the optimal treatment for irritable bowel syndrome (IBS). Psychological treatments are increasingly advocated but their effectiveness is unclear. Objectives To evaluate the efficacy of psychological interventions for the treatment of irritable bowel syndrome. Search strategy A computer assisted search ofMEDLINE, EMBASE, PsychInfo, CINAHL,Web of Science, The Cochrane Library and Google Scholar was performed for the years 1966-2008. Local databases were searched in Europe. Selection criteria Randomised trials comparing single psychological interventions with either usual care or mock interventions in patients over 16 years of age. No language criterion was applied. Data collection and analysis The search identified 25 studies that fulfilled the inclusion criteria. The relative risk (RR), risk difference (RD), number needed to treat (NNT) and standardized mean difference (SMD) along with 95% confidence intervals were calculated using a random effects model for each outcome. Main results Psychological interventions as a group The SMD for symptom score improvement at 2 and 3 months was 0.97 (95% CI 0.29 to 1.65) and 0.62 (95% CI 0.45 to 0.79) respectively compared to usual care. Against placebo, the SMDs were 0.71 (95% CI 0.08 to 1.33) and -0.17 (95% CI -0.45 to 0.11) respectively. For improvement of abdominal pain, the SMDs at 2 and 3 months were 0.54 (95%CI 0.10 to 0.98) and 0.26 (95% CI 0.07 to 0.45) compared to usual care. The SMD from placebo at 3 months was 0.31 (95% CI -0.16 to 0.79). For improvement in quality of life, the SMDfromusual care at 2 and 3months was 0.47 (95%CI 0.11 to 0.84) and 0.31 (95%CI -0.16 to 0.77) respectively. Cognitive behavioural therapy The SMD for symptom score improvement at 2 and 3 months was 0.75 (95% CI -0.20 to 1.70) and 0.58 (95% CI 0.36 to 0.79) respectively compared to usual care. Against placebo, the SMDs were 0.68 (95% CI -0.01 to 1.36) and -0.17 (95% CI -0.45 to 0.11) respectively. For improvement of abdominal pain, the SMDs at 2 and 3 months were 0.45 (95% CI 0.00 to 0.91) and 0.22 (95% CI - 0.04 to -0.49) compared to usual care. Against placebo the SMD at 3 months was 0.33 (95% CI -0.16 to 0.82). For improvement in quality of life, the SMDs at 2 and 3 months compared to usual care were 0.44 (95% CI 0.04 to 0.85) and 0.92 (95% CI 0.07 to 1.77) respectively. Interpersonal psychotherapy The RR for adequate relief of symptoms was 2.02 (95% CI 1.13 to 3.62), RD 0.30 (95% CI 0.13 to 0.46), NNT 4 for comparison with care as usual. The SMD for improvement of symptom score was 0.35 (95% CI -0.75 to 0.05) compared with usual care. Relaxation/Stress management The SMD in symptom score improvement at 2 months was 0.50 (95%CI 0.02 to 0.98) compared with usual care. The SMD in improvement of abdominal pain at 3 months was 0.02 (95%CI -0.56 to 0.61) compared with usual care. Long term results Very few long term follow-up results were available. There was no convincing evidence that treatment effects were sustained following completion of treatment for any treatment modality. Authors’ conclusions Psychological interventions may be slightly superior to usual care or waiting list control conditions at the end of treatment although the clinical significance of this is debatable. Except for a single study, these therapies are not superior to placebo and the sustainability of their effect is questionable. The meta-analysis was significantly limited by issues of validity, heterogeneity, small sample size and outcome definition. Future research should adhere to current recommendations for IBS treatment trials and should focus on the longterm effects of treatment.
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Objective: Funnel plots (plots of effect estimates against sample size) may be useful to detect bias in meta-analyses that were later contradicted by large trials. We examined whether a simple test of asymmetry of funnel plots predicts discordance of results when meta-analyses are compared to large trials, and we assessed the prevalence of bias in published meta-analyses. Design: Medline search to identify pairs consisting of a meta-analysis and a single large trial (concordance of results was assumed if effects were in the same direction and the meta-analytic estimate was within 30
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Self-help interventions for psychiatric disorders represent an increasingly popular alternative to therapist-administered psychological therapies, offering the potential of increased access to cost-effective treatment. To determine the efficacy, cost-effectiveness and acceptability of self-help interventions for anxiety disorders. Randomised controlled trials (RCTs) of self-help interventions for anxiety disorders were identified by searching nine online databases. Studies were grouped according to disorder and meta-analyses were conducted where sufficient data were available. Overall meta-analyses of self-help v. waiting list and therapist-administered treatment were also undertaken. Methodological quality was assessed independently by two researchers according to criteria set out by the Cochrane Collaboration. Thirty-one RCTs met inclusion criteria for the review. Results of the overall meta-analysis comparing self-help with waiting list gave a significant effect size of 0.84 in favour of self-help. Comparison of self-help with therapist-administered treatments revealed a significant difference in favour of the latter with an effect size of 0.34. The addition of guidance and the presentation of multimedia or web-based self-help materials improved treatment outcome. Self-help interventions appear to be an effective way of treating individuals diagnosed with social phobia and panic disorder. Further research is required to evaluate the cost-effectiveness and acceptability of these interventions.
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Flaws in the design, conduct, analysis, and reporting of randomised trials can cause the effect of an intervention to be underestimated or overestimated. The Cochrane Collaboration’s tool for assessing risk of bias aims to make the process clearer and more accurate
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Internet-based cognitive behavior therapy (ICBT) has shown promising effects in the treatment of irritable bowel syndrome (IBS). However, to date no study has used a design where participants have been sampled solely from a clinical population. We aimed to investigate the acceptability, effectiveness, and cost-effectiveness of ICBT for IBS using a consecutively recruited sample from a gastroenterological clinic. Sixty-one patients were randomized to 10 weeks of ICBT (n = 30) or a waiting list control (n = 31). The ICBT was guided by an online therapist and emphasized acceptance of symptoms through exposure and mindfulness training. Severity of IBS symptoms was measured with the Gastrointestinal symptom rating scale--IBS version (GSRS-IBS). Patients in both groups were assessed at pre- and post-treatment while only the ICBT group was assessed 12 months after treatment completion. Health economic data were also gathered at all assessment points and analyzed using bootstrap sampling. Fifty of 61 patients (82%) completed the post-treatment assessment and 20 of 30 patients (67%) in the ICBT group were assessed at 12-month follow-up. The ICBT group demonstrated significantly (p < .001) larger improvements on the IBS-related outcome scales than the waiting list group. The between group effect size on GSRS-IBS was Cohen's d = 0.77 (95% CI: 0.19-1.34). Similar effects were noted on measures of quality of life and IBS-related fear and avoidance behaviors. Improvements in the ICBT group were maintained at 12-month follow-up. The ICBT condition was found to be more cost-effective than the waiting list, with an 87% chance of leading to reduced societal costs combined with clinical effectiveness. The cost-effectiveness was sustained over the 12-month period. ICBT proved to be a cost-effective treatment when delivered to a sample recruited from a gastroenterological clinic. However, many of the included patients dropped out of the study and the overall treatment effects were smaller than previous studies with referred and self-referred samples. ICBT may therefore be acceptable and effective for only a subset of clinical patients. Study dropout seemed to be associated with severe symptoms and large impairment. Objective and empirically validated criteria to select which patients to offer ICBT should be developed. ClinicalTrials.gov: NCT00844961.
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This is the protocol for a review and there is no abstract. The objectives are as follows: To evaluate the effectiveness of psychotherapeutic interventions for chronic pain management delivered via the internet, in comparison with an active control, treatment-as-usual, or waiting list control.
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OBJECTIVES: Irritable bowel syndrome (IBS) and chronic idiopathic constipation (CIC) are functional bowel disorders. Evidence suggests that disturbance in the gastrointestinal microbiota may be implicated in both conditions. We performed a systematic review and meta-analysis to examine the efficacy of prebiotics, probiotics, and synbiotics in IBS and CIC. METHODS: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were searched (up to December 2013). Randomized controlled trials (RCTs) recruiting adults with IBS or CIC, which compared prebiotics, probiotics, or synbiotics with placebo or no therapy, were eligible. Dichotomous symptom data were pooled to obtain a relative risk (RR) of remaining symptomatic after therapy, with a 95% confidence interval (CI). Continuous data were pooled using a standardized or weighted mean difference with a 95% CI. RESULTS: The search strategy identified 3,216 citations. Forty-three RCTs were eligible for inclusion. The RR of IBS symptoms persisting with probiotics vs. placebo was 0.79 (95% CI 0.70-0.89). Probiotics had beneficial effects on global IBS, abdominal pain, bloating, and flatulence scores. Data for prebiotics and synbiotics in IBS were sparse. Probiotics appeared to have beneficial effects in CIC (mean increase in number of stools per week=1.49; 95% CI=1.02-1.96), but there were only two RCTs. Synbiotics also appeared beneficial (RR of failure to respond to therapy=0.78; 95% CI 0.67-0.92). Again, trials for prebiotics were few in number, and no definite conclusions could be drawn. CONCLUSIONS: Probiotics are effective treatments for IBS, although which individual species and strains are the most beneficial remains unclear. Further evidence is required before the role of prebiotics or synbiotics in IBS is known. The efficacy of all three therapies in CIC is also uncertain.
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Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disease characterized by abdominal pain and discomfort, bloating, and altered bowel function (constipation, diarrhea, or both). Since there is no known cause and no panacea for the multiple manifestations of IBS, therapy is targeted toward improving specific symptoms. The American College of Gastroenterology published an evidence-based position statement on the management of IBS. Treatments were graded from A (accurate based on evidence) to C (prone to multiple biases) based on the quality of the supporting studies. None of the traditional treatments (bulking agents, antispasmodics, tricyclic antidepressants, and behavioral therapy) received a grade A. The clinical trials for these agents were generally considered weak on methodologic grounds. Newer agents, such as 5-HT3 antagonists and 5-HT4 agonists, are effective but may cause serious complications in some patients. Lubiprostone is the newest agent approved by the US Food and Drug Administration for the treatment of women with IBS and constipation.
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The aim of this study was to evaluate the role of engagement with homework tasks in a brief, self-help CBT based intervention for irritable bowel syndrome (IBS). Thirty one IBS participants who were randomised to receive the self-management programme participated in this part of the study. Participants completed a seven week self-management programme which consisted of a detailed self-help manual that included weekly structured homework tasks, an initial face-to-face session with a CBT therapist, and two hour-long telephone sessions at three and five weeks into the programme. In order to assess improvement across the trial, patients completed questionnaires at baseline, post treatment and three months follow-up measuring the severity of their IBS symptoms and their level of symptom relief. Homework sheets were returned at the end of therapy and rated by two independent raters for quantity and quality of homework completed. There were no significant differences between improvers and non-improvers at the end of treatment in either the quality or quantity of homework completed. However, at three months post treatment people who had symptom improvement had completed significantly more homework during their treatment and the quality of this homework was greater than people who had not improved. Encouraging patients to engage in self-help activities may increase the efficacy of this form of therapy.
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Background: Our aim was to determine the costeffectiveness of newer antidepressants compared with tricyclic antidepressants in managed care organization settings. Method: We employed cost-utility analysis based on a clinical decision analysis model derived from published medical literature and physician judgment. The model, which represents ideal primary care practice, compares treatment with nefazodone to treatment with either imipramine or fluoxetine or to a step approach involving initial treatment with imipramine followed by nefazodone for treatment failures. The outcome measures were lifetime medical costs, quality-adjusted life years (QALYs), and costs per QALY gained. Results: The base case analysis found that nefazodone treatment had $16,669 in medical costs, compared with $15,348 for imipramine, $16,061 for the imipramine step approach, and $16,998 for fluoxetine. QALYs were greatest for nefazodone (14.64), compared with 14.32 for imipramine, 14.40 for the step approach, and 14.58 for fluoxetine. The costeffectiveness ratio comparing nefazodone with imipramine was $4065 per QALY gained. The costeffectiveness ratio comparing nefazodone with the step approach was $2555 per QALY gained. There were only minor differences in costs and outcomes between nefazodone and fluoxetine, with nefazodone resulting in $329 fewer costs and 0.06 more QALYs. The cost-effectiveness ratios comparing fluoxetine with imipramine and with the step approach were $6346 per QALY gained and $5206 per QALY gained, respectively. In the sensitivity analyses, the cost-effectiveness ratios comparing nefazodone and imipramine ranged from $2572 to $5841 per QALY gained. The model was most sensitive to assumptions about treatment compliance rates. Conclusion: The findings suggest that nefazodone is a cost-effective treatment compared with imipramine or fluoxetine treatment for major depression. Fluoxetine is cost-effective compared with imipramine treatment, but is estimated to have slightly more medical costs and less effectiveness compared with nefazodone. The basic findings and conclusions do not change even after modifying key model parameters.
Article
Objectives: Psychological interventions can alleviate the symptoms of irritable bowel syndrome (IBS) and psychological distress commonly reported among IBS sufferers. However, the theoretical underpinnings and intervention techniques used by such interventions vary considerably. This study aimed to identify which theoretical approaches and techniques lead to greater improvements in IBS symptoms and psychological well-being within psychological interventions for IBS. Methods: Outcome data were extracted from 48 randomized controlled trials testing psychological treatments for IBS. Theoretical intervention targets and intervention techniques of each study were identified. Cumulative effect sizes were calculated for pain, bowel dysfunction, composite symptom scores, psychological distress, and health-related quality of life. Comparative analyses contrasted the effect sizes of studies which included each intervention technique to those which did not. Results: Cumulatively, interventions significantly improved all outcomes, with effect sizes (Hedges' g) ranging from 0.32 to 0.64. Interventions which stated a theoretical intervention target, prompted self-monitoring of symptoms and cognitions, provided tailored feedback linking symptoms and cognitions, utilized problem solving or assertiveness training and provided general support had greater effects upon symptom and well-being outcomes than interventions which did not (all P<.05). Across all studies, improvements in psychological distress were associated with improvements in composite symptom scores (P<.01). Conclusions: This study identifies a set of techniques associated with improvements in IBS symptoms and psychological well-being in existing interventions, and provides initial evidence for the link between improvements in psychological distress and IBS composite symptom scores. These findings can aid the development and refinement of psychological treatments for IBS.
Article
Background: Irritable bowel syndrome (IBS) is highly prevalent in young women under stressful conditions. Cognitive behavioral therapy (CBT) has been known to be effective in treating IBS. Aims: This study aimed to evaluate the clinical outcomes of CBT in female nursing students with IBS. The primary outcome measure of the study was the Bowel Symptom Severity Scale-IBS version. Patients and methods: Ninety diagnosed participants were randomized to each group in a randomized pretest-post-test control group design. The experimental group received an 8-week CBT intervention, and the control group received general information on IBS. Bowel symptom severity, dysfunctional attitudes, and IBS-quality of life were assessed at baseline and after 8, 16, and 24 weeks. Six experimental and eight control participants withdrew during the study because of various reasons. Results: Significant effects were found for bowel symptom severity (frequency: P<0.001; distress: P<0.001; disability: P<0.001) between the experimental (n=39) and the control (n=37) groups. The overall IBS-quality of life improved over time in the CBT group (P<0.001). The CBT also showed the alleviation of dysphoria (P=0.010), interference with activity (P=0.031), and health worry (P=0.009), and the improvement of body image (P=0.008) and relationships (P=0.041) compared with the control group. Conclusion: CBT proved to be an effective intervention for improving the clinical states of IBS in young female nursing students.
Article
Standard medical treatments have not been effective for irritable bowel syndrome (IBS) patients. Though individualized cognitive–behavior therapy is an empirically supported treatment option, cognitive–behavioral group therapy (CBGT) has yet to be established as an effective alternative in a randomized controlled trial. This study compared the efficacy of a 10-session CBGT with a home-based symptom monitoring with weekly telephone contact (SMTC) treatment for IBS, extending previous quasi-experimental research in this area. Twenty-eight refractory IBS patients, evaluated and referred by gastroenterologists using the Rome criteria, participated in the study. IBS symptoms, psychological functioning, and health-related quality of life were assessed pre- and posttreatment, and at 3-month follow-up. CBGT patients reported significantly more gastrointestinal (GI) symptom improvement than SMTC patients on posttreatment global measures and had significantly reduced daily diary pain scores at 3-month follow-up. Based on MANOVA, there was significant improvement in psychological distress and health-related quality of life for the CBGT patients in comparison to the SMTC patients. These improvements were also maintained at the 3-month follow-up. Reductions in GI symptoms, psychological distress, and improved health related quality of life may contribute to less behavioral avoidance, disability, and health care utilization in refractory IBS patients.
Article
To determine the effectiveness of an intervention to enhance self management support for patients with chronic conditions in UK primary care. Pragmatic, two arm, cluster randomised controlled trial. General practices, serving a population in northwest England with high levels of deprivation. 5599 patients with a diagnosis of diabetes (n=2546), chronic obstructive pulmonary disease (n=1634), and irritable bowel syndrome (n=1419) from 43 practices (19 intervention and 22 control practices). Practice level training in a whole systems approach to self management support. Practices were trained to use a range of resources: a tool to assess the support needs of patients, guidebooks on self management, and a web based directory of local self management resources. Training facilitators were employed by the health management organisation. Primary outcomes were shared decision making, self efficacy, and generic health related quality of life measured at 12 months. Secondary outcomes were general health, social or role limitations, energy and vitality, psychological wellbeing, self care activity, and enablement. We randomised 44 practices and recruited 5599 patients, representing 43% of the eligible population on the practice lists. 4533 patients (81.0%) completed the six month follow-up and 4076 (72.8%) the 12 month follow-up. No statistically significant differences were found between patients attending trained practices and those attending control practices on any of the primary or secondary outcomes. All effect size estimates were well below the prespecified threshold of clinically important difference. An intervention to enhance self management support in routine primary care did not add noticeable value to existing care for long term conditions. The active components required for effective self management support need to be better understood, both within primary care and in patients' everyday lives. Current Controlled Trials ISRCTN90940049.
Article
Objective: The implementation of new interventions into routine care requires the demonstration of both their effectiveness and cost-effectiveness. Method: We explored the cost-effectiveness of an Internet-based aftercare program in addition to treatment as usual (CHAT) which was compared to treatment as usual (TAU) following inpatient treatment. Incremental cost-effectiveness ratios were calculated based on cost of the intervention, cost of outpatient treatment, and remission rates within 1 year after discharge from hospital. Results: Assuming a willingness-to-pay of an additional 14.87 € per treatment for every additional percent of remission, CHAT was cost-effective against TAU at a 95% level of certainty. Cost per remission equaled 2664.84 € in TAU and 1752.75 € in CHAT (34.2% savings). Conclusions: This is the first evidence that Internet-based aftercare may enhance long-term treatment outcome in a cost-effective way.
Article
Previous research has recommended several measures of effect size for studies with repeated measurements in both treatment and control groups. Three alternate effect size estimates were compared in terms of bias, precision, and robustness to heterogeneity of variance. The results favored an effect size based on the mean pre-post change in the treatment group minus the mean pre-post change in the control group, divided by the pooled pretest standard deviation.
Background : Although little mortality is associated with irritable bowel syndrome, curative therapy does not exist and thus the economic impact of this disorder may be considerable. Methods : A systematic review of the literature was performed. Studies were included if their focus was irritable bowel syndrome, and direct and/or productivity (indirect) costs were reported. Two investigators abstracted the data independently. Results : One hundred and seventy-four studies were retrieved by the search; 11 fulfilled all criteria for entry into the review. The mean direct costs of irritable bowel syndrome management were reported to be UK£90, Canadian$259 and US$619 per patient annually, with total annual direct costs related to irritable bowel syndrome of £45.6 million (UK) and $1.35 billion (USA). Direct resource consumption of all health care for irritable bowel syndrome patients ranged from US$742 to US$3166. Productivity costs ranged from US$335 to US$748, with total annual costs of $205 million estimated in the USA. Annual expenditure for all health care, in addition to expenditure limited to gastrointestinal disorders, was significantly higher in irritable bowel syndrome patients than in control populations. Conclusions : Despite the lack of significant mortality, irritable bowel syndrome is associated with high direct and productivity costs. Irritable bowel syndrome patients consume more gastrointestinal-related and more total health care resources than non-irritable bowel syndrome controls, and sustain significantly greater productivity losses.
Article
This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life , which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty , within the domain of ambulation , and ambulation may be further grouped into the concept of physical ability ). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration- February 2006.
Article
Objective: Chronic illness places high demands on patients. Interventions supporting self-management and providing personalized feedback might help patients to gain new perspectives and enhance use of constructive self-management strategies. We developed three comparable web-based CBT-grounded interventions including e-diaries and feedback delivered through PDAs/smartphones. The feasibility and efficacy of these interventions have been investigated for patients with irritable bowel syndrome (in an RCT), chronic widespread pain (RCT) and type 2 diabetes (feasibility study). Methods: This is a descriptive study that summarizes the content, feasibility and efficacy of the interventions and discusses issues relevant for implementing this type of web-based therapeutic interventions in clinical practice. Results: The web-based interventions appear feasible, acceptable and supportive. In a short and midterm time frame, the interventions promote self-management. Conclusion: Booster sessions may be needed for prolonged effects. Given the physical and mental symptoms of the patients under study and the nature of the intervention, providers who deliver the feedback need a health care background and training in this specific way of counseling. Practice implications: The results of the three studies suggest that personalized web-based interventions are effective and have the potential to support self-management in daily healthcare. Studies concerning clinical significance and implementation are needed.
Article
Presents an approach for the meta-analysis of data from pretest–posttest designs. With this approach, data from studies using different designs may be compared directly and studies without control groups do not need to be omitted. The approach is based on a standardized mean-change measure, computed for each sample within a study, and it involves analysis of the standardized mean changes and differences in the standardized mean changes. Analyses are illustrated using results of studies of the effectiveness of mental practice on motor-skill development (e.g., D. Feltz and D. M. Landers [see PA, Vol 71:325]). (PsycINFO Database Record (c) 2012 APA, all rights reserved)
Article
Irritable bowel syndrome is a common, oftentimes disabling, gastrointestinal disorder whose full range of symptoms has no satisfactory medical or dietary treatment. One of the few empirically validated treatments includes a specific psychological therapy called cognitive behavior therapy which, if available, is typically administered over several months by trained practitioners in tertiary care settings. There is an urgent need to develop more efficient versions of CBT that require minimal professional assistance but retain the efficacy profile of clinic based CBT. The Irritable Bowel Syndrome Outcome Study (IBSOS) is a multicenter, placebo-controlled randomized trial to evaluate whether a self-administered version of CBT is, at least as efficacious as standard CBT and more efficacious than an attention control in reducing core GI symptoms of IBS and its burden (e.g. distress, quality of life impairment, etc.) in moderately to severely affected IBS patients. Additional goals are to assess, at quarterly intervals, the durability of treatment response over a 12month period; to identify clinically useful patient characteristics associated with outcome as a way of gaining an understanding of subgroups of participants for whom CBT is most beneficial; to identify theory-based change mechanisms (active ingredients) that explain how and why CBT works; and evaluate the economic costs and benefits of CBT. Between August 2010 when IBSOS began recruiting subjects and February 2012, the IBSOS randomized 171 of 480 patients. Findings have the potential to improve the health of IBS patients, reduce its social and economic costs, conserve scarce health care resources, and inform evidence-based practice guidelines.
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Given the well-documented shortage of cognitive-behavioral therapy (CBT) for eating disorders, there is a compelling need for advances in dissemination. Guided self-help based on cognitive-behavioral principles (CBTgsh) provides a robust means of improving implementation and scalability of evidence-based treatment for eating disorders. It is a brief, cost-effective treatment that can be implemented by a wide range of mental health providers, including non-specialists, via face-to-face contact and internet-based technology. Controlled studies have shown that CBTgsh can be an effective treatment for binge eating disorder and bulimia nervosa, although it is contraindicated for anorexia nervosa. Several studies have shown that CBTgsh can be as effective as more complex specialty therapies and that it is not necessarily contraindicated for patients with comorbid conditions. Mental health providers with relatively minimal professional credentials have in some studies obtained results comparable to specialized clinicians. Establishing the nature of optimal "guidance" in CBTgsh and the level of expertise and training required for effective implementation is a research priority. Existing manuals used in CBTgsh are outdated and can be improved by incorporating the principles of enhanced transdiagnostic CBT. Obstacles to wider adoption of CBTgsh are identified.
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Increasing rates of prescriptions for antidepressants, antipsychotics and stimulants have been reported from various countries. To examine trends in prescriptions and the costs of all classes of psychiatric medication in England. Data from the Prescription Cost Analysis 1998-2010 was examined, using linear regression analysis to examine trends. Prescriptions of drugs used for mental disorders increased by 6.8% (95% CI 6.3-7.4) per year on average, in line with other drugs, but made up an increasing proportion of all prescription drug costs (P = 0.001). There were rising trends in prescriptions of all classes of psychiatric drugs, except anxiolytics and hypnotics (which did not change). Antidepressant prescriptions increased by 10% (95% CI 9.0-11) per year on average, and antipsychotics by 5.1% (95% CI 4.3-5.9). Antipsychotics overtook antidepressants as the most costly class of psychiatric medication, with costs rising 22% (95% CI 17-27) per year. Rising prescriptions may be partly explained by longer-term treatment and increasing population. Nevertheless, it appears that psychiatric drugs make an increasing contribution to total prescription drug costs, with antipsychotics becoming the most costly. Low-dose prescribing of some antipsychotics is consistent with other evidence that their use may not be restricted to those with severe mental illness.
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Women with irritable bowel syndrome (IBS) report sexual dysfunction. Comprehensive self-management (CSM) intervention has been shown to reduce gastrointestinal, psychological, and somatic symptoms in IBS women. Whether this intervention also reduces sexual dysfunction is not known. We sought to compare demographic and clinical factors in IBS women with and without sexual dysfunction as defined by the Arizona sexual experiences scale (ASEX) and to test the effects of CSM treatment on sexual dysfunction scores and on the sexual relations subscale of an IBS quality of life (IBSQOL) scale which measures the effect of IBS on sexual QOL. IBS (Rome II) women enrolled in a randomized clinical trial of CSM treatment were characterized as having sexual dysfunction (N = 89) or not (N = 86) at baseline based on ASEX criteria. Baseline characteristics and symptoms were compared between the two groups. Post-intervention changes were compared between the CSM and the usual care arms of the randomized trial. Women meeting ASEX criteria for sexual dysfunction were older, had higher lifetime depression and antidepressant use, more primary care/MD visits, fewer mental healthcare visits, and greater sleep disturbance than those without sexual dysfunction. No significant group differences in gastrointestinal or somatic symptoms were observed. Compared with usual care treatment, CSM increased sexual QOL scores and had a weaker effect on ASEX scores. Severity of IBS symptoms at baseline did not differ between IBS women with or without sexual dysfunction. The CSM intervention can reduce the effect of IBS on sexual QOL.
Article
Irritable bowel syndrome (IBS) imposes significant clinical and economic burdens. We aimed to characterize practice patterns for patients with IBS in a large health maintenance organization, analyzing point of diagnosis, testing, comorbidities, and treatment. Members of Kaiser Permanente Northern California who were diagnosed with IBS were matched to controls by age, sex, and period of enrollment. We compared rates of testing, comorbidities, and interventions. From 1995-2005, IBS was diagnosed in 141,295 patients (mean age, 46 years; standard deviation, 17 years; 74% female). Internists made 68% of diagnoses, gastroenterologists 13%, and others 19%. Lower endoscopy did not usually precede IBS diagnosis. Patients with IBS were more likely than controls to have blood, stool, endoscopic, and radiologic tests and to undergo abdominal or pelvic operations (odds ratios, 1.5-10.7; all P < .0001). Only 2.7% were tested for celiac disease, and only 1.8% were eventually diagnosed with inflammatory bowel disease. Chronic pain syndromes, anxiety, and depression were more common among IBS patients than among controls (odds ratios, 2.7-4.6; all P < .0001). Many patients with IBS were treated with anxiolytics (61%) and antidepressants (55%). Endoscopic and radiologic testing was most strongly associated with having IBS diagnosed by a gastroenterologist. Psychotropic medication use was most strongly associated with female sex. In a large, managed care cohort, most diagnoses of IBS were made by generalists, often without endoscopic evaluation. Patients with IBS had consistently higher rates of testing, chronic pain syndromes, psychiatric comorbidity, and operations than controls. Most patients with IBS were treated with psychiatric medications.