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StayWell at Home study design.
Source publication
Background: Social distancing is a crucial intervention to slow down person-to-person transmission of COVID-19. However,
social distancing has negative consequences, including increases in depression and anxiety. Digital interventions, such as text
messaging, can provide accessible support on a population-wide scale. We developed text messages in E...
Contexts in source publication
Context 1
... used the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist when writing this protocol [17]. Figure 1 shows our study design. ...
Citations
... MRTs can also provide useful information regarding the selection of decision points. For example, time frames can be treated as an experimental factor to examine the differential intervention effects (2,38), addressing the question of when to intervene each day and with what intervention component. ...
This review explores the transformative potential of just-in-time adaptive interventions (JITAIs) as a scalable solution for addressing health disparities in underserved populations. JITAIs, delivered via mobile health technologies, could provide context-aware personalized interventions based on real-time data to address public health challenges such as addiction, chronic disease, and mental health management. JITAIs can dynamically adjust intervention strategies, enhancing accessibility and engagement for marginalized communities. We highlight the utility of JITAIs in reducing opportunity costs associated with traditional in-person health interventions. Examples from various health domains demonstrate the adaptability of JITAIs in tailoring interventions to meet diverse needs. The review also emphasizes the need for community involvement, robust evaluation frameworks, and ethical considerations in implementing JITAIs, particularly in low- and middle-income countries. Sustainable funding models and technological innovations are necessary to ensure equitable access and effectively scale these interventions. By bridging the gap between research and practice, JITAIs could improve health outcomes and reduce disparities in vulnerable populations.
... Fourth, MB-VG includes text messaging to promote session attendance, encourage skill practice, and reinforce health-related content delivered by the pediatric health care provider. We will send text messages 24-72 h apart via the HealthySMS system, a web-based platform used to deploy text messages in previous MB studies [45] and other studies of mental health interventions [46,47]. ...
Background
Immigrant Latinas (who are foreign-born but now reside in the USA) are at greater risk for developing postpartum depression than the general perinatal population, but many face barriers to treatment. To address these barriers, we adapted the Mothers and Babies Course—an evidence-based intervention for postpartum depression prevention—to a virtual group format. Additional adaptations are inclusion of tailored supplemental child health content and nutrition benefit assistance. We are partnering with Early Learning Centers (ELC) across the state of Maryland to deliver and test the adapted intervention.
Methods
The design is a Hybrid Type I Effectiveness-Implementation Trial. A total of 300 participants will be individually randomized to immediate (N = 150) versus delayed (N = 150) receipt of the intervention, Mothers and Babies Virtual Group (MB-VG). The intervention will be delivered by trained Early Learning Center staff. The primary outcomes are depressive symptoms (measured via the Center for Epidemiologic Studies-Depression Scale), parenting self-efficacy (measured via the Parental Cognition and Conduct Towards the Infant Scale (PACOTIS) Parenting Self-Efficacy subscale), and parenting responsiveness (measured via the Maternal Infant Responsiveness Instrument) at 1-week, 3-month, and 6-month post-intervention. Depressive episodes (Structured Clinical Interview for DSM-V- Disorders Research Version) at 3-month and 6-month post-intervention will also be assessed. Secondary outcomes include social support, mood management, anxiety symptoms, perceived stress, food insecurity, and mental health stigma at 1-week, 3-month, and 6-month post-intervention. Exploratory child outcomes are dysregulation and school readiness at 6-month post-intervention. Intervention fidelity, feasibility, acceptability, and appropriateness will also be assessed guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.
Discussion
This study will be one of the first to test the efficacy of a group-based virtual perinatal depression intervention with Latina immigrants, for whom stark disparities exist in access to health services. The hybrid effectiveness-implementation design will allow rigorous examination of barriers and facilitators to delivery of the intervention package (including supplemental components) which will provide important information on factors influencing intervention effectiveness and the scalability of intervention components in Early Learning Centers and other child-serving settings.
Registration
ClinicalTrials.gov NCT05873569.
... At the start of the pandemic, our team developed the StayWell at Home intervention, a 60-day text messaging program based on our group's previous text-messaging cognitive behavioral therapy (CBT) work [5]. Our goal was to help people cope with the uncertainties and lifestyle changes of the global crisis using evidence-based tools. ...
... First, a tip message was randomly selected from the two categories described above and sent daily between 9 am-6 pm followed by a mood-monitoring message three hours later. We designed the messages in English and Spanish to reach diverse populations, particularly monolingual Spanish speakers who are often excluded from digital health interventions [5]. The delivery of text messages and collection of self-reported mood ratings was conducted via a HIPPA-compliant platform, HealthySMS. ...
The StayWell at Home intervention, a 60-day text-messaging program based on Cognitive Behavioral Therapy (CBT) principles, was developed to help adults cope with the adverse effects of the global pandemic. Participants in StayWell at Home were found to show reduced depressive and anxiety symptoms after participation. However, it remains unclear whether the intervention improved mood and which intervention components were most effective at improving user mood during the pandemic. Thus, utilizing a micro-randomized trial (MRT) design, we examined two intervention components to inform the mechanisms of action that improve mood: 1) text messages delivering CBT-informed coping strategies (i.e., behavioral activation, other coping skills, or social support); 2) time at which messages were sent. Data from two independent trials of StayWell are included in this paper. The first trial included 303 adults aged 18 or older, and the second included 266 adults aged 18 or older. Participants were recruited via online platforms (e.g., Facebook ads) and partnerships with community-based agencies aiming to reach diverse populations, including low-income individuals and people of color. The results of this paper indicate that participating in the program improved and sustained self-reported mood ratings among participants. We did not find significant differences between the type of message delivered and mood ratings. On the other hand, the results from Phase 1 indicated that delivering any type of message in the 3 pm-6 pm time window improved mood significantly over sending a message in the 9 am-12 pm time window. The StayWell at Home program increases in mood ratings appeared more pronounced during the first two to three weeks of the intervention and were maintained for the remainder of the study period. The current paper provides evidence that low-burden text-message interventions may effectively address behavioral health concerns among diverse communities.
... At each decision time point, a participant is randomly assigned to one of the available intervention options. There exist several research studies using the MRT design, for example, 'HeartSteps' for promoting physical activity among sedentary people, 11 'Sense2Stop' for managing stress in newly abstinent smokers, 12 'DIAMANTE' 13 for promoting physical activity among co-morbid diabetes and depression patients, 'StayWell' 14 for managing people's mental wellness during COVID-19 pandemic period, and so on. ...
... Alternatively, the proximal effect trend for categorym can also be described as having a combination of the linear and constant trends, where it increases or decreases linearly until a turning point on day d m turn and plateaus afterwards, as demonstrated in the StayWell study results. 14 We call it the 'linear-plateau' trend. In this case, we can define the proximal effect size using a linear spline, that is ...
... avoiding the unnecessary increases in both the sample size and the study duration) of allowing additional categories to be added later in the trial. Take the StayWell study as an example (contact the authors of Figueroa et al.14 for relevant details), where two consecutive MRTs were conducted, the first with two categories and the latter with an additional category (three categories in total) at the beginning of each trial. Assuming all other design parameters are specified inFigure 2(a), the total sample size needed for the two trials is N = 65. ...
Technological advancements have made it possible to deliver mobile health interventions to individuals. A novel framework that has emerged from such advancements is the just-in-time adaptive intervention, which aims to suggest the right support to the individuals when their needs arise. The micro-randomized trial design has been proposed recently to test the proximal effects of the components of these just-in-time adaptive interventions. However, the extant micro-randomized trial framework only considers components with a fixed number of categories added at the beginning of the study. We propose a more flexible micro-randomized trial design which allows addition of more categories to the components during the study. Note that the number and timing of the categories added during the study need to be fixed initially. The proposed design is motivated by collaboration on the Diabetes and Mental Health Adaptive Notification Tracking and Evaluation study, which learns to deliver effective text messages to encourage physical activity among patients with diabetes and depression. We developed a new test statistic and the corresponding sample size calculator for the flexible micro-randomized trial using an approach similar to the generalized estimating equation for longitudinal data. Simulation studies were conducted to evaluate the sample size calculators and an R shiny application for the calculators was developed.
Randomized controlled trials can be used to generate evidence on the efficacy and safety of new treatments in eating disorders research. Many of the trials previously conducted in this area have been deemed to be of low quality, in part due to a number of practical constraints. This article provides an overview of established and more innovative clinical trial designs, accompanied by pertinent examples, to highlight how design choices can enhance flexibility and improve efficiency of both resource allocation and participant involvement. Trial designs include individually randomized, cluster randomized, and designs with randomizations at multiple time points and/or addressing several research questions (master protocol studies). Design features include the use of adaptations and considerations for pragmatic or registry‐based trials. The appropriate choice of trial design, together with rigorous trial conduct, reporting and analysis, can establish high‐quality evidence to advance knowledge in the field. It is anticipated that this article will provide a broad and contemporary introduction to trial designs and will help researchers make informed trial design choices for improved testing of new interventions in eating disorders.
Public Significance
There is a paucity of high quality randomized controlled trials that have been conducted in eating disorders, highlighting the need to identify where efficiency gains in trial design may be possible to advance the eating disorder research field. We provide an overview of some key trial designs and features which may offer solutions to practical constraints and increase trial efficiency.
Text messaging interventions are increasingly used to help people manage depression and anxiety. However, little is known about the effectiveness and implementation of these interventions among U.S. Latinxs, who often face barriers to using mental health tools. The StayWell at Home (StayWell) intervention, a 60-day text messaging program based on cognitive behavioral therapy (CBT), was developed to help adults cope with depressive and anxiety symptoms during the COVID-19 pandemic. StayWell users (n = 398) received daily mood
inquiries and automated skills-based text messages delivering CBT-informed coping strategies from an investigator-generated message bank. We conduct a Hybrid Type 1 mixed-methods study to compare the effectiveness and implementation of StayWell for Latinx and Non-Latinx White (NLW) adults using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Effectiveness was measured using the PHQ-8 depression and GAD-7 anxiety scales, assessed before starting and after completing StayWell. Guided by RE-AIM, we conducted a thematic text analysis of responses to an open-ended question about user experiences to help contextualize quantitative findings. Approximately 65.8% (n = 262) of StayWell users completed pre-and-post surveys. On average, depressive (1.48, p = 0.001) and anxiety (1.38, p = 0.001) symptoms decreased from pre-to-post StayWell. Compared to NLW users (n = 192), Latinx users (n = 70) reported an additional 1.45 point (p < 0.05) decline in depressive symptoms, adjusting for demographics. Although Latinxs reported StayWell as relatively less useable (76.8 vs. 83.9, p = 0.001) than NLWs, they were more interested in continuing the program (7.5 vs. 6.2 out of 10, p = 0.001) and recommending it to a family member/friend (7.8 vs. 7.0 out of 10, p = 0.01). Based on the thematic analysis, both Latinx and NLW users enjoyed responding to mood inquiries and sought bi-directional, personalized text messages and texts with links to more information to resources. Only NLW users stated that StayWell provided no new information than they already knew from therapy or other sources. In contrast, Latinx users suggested that engagement with a behavioral provider through text or support groups would be beneficial, highlighting this group’s unmet need for behavioral health care. mHealth interventions like StayWell are well-positioned to address population-level disparities by serving those with the greatest unmet needs if they are culturally adapted and actively disseminated to marginalized groups.
Just-in-time adaptive interventions (JITAIs) represent an intervention design that adapts the provision and type of support over time to an individual’s changing status and contexts, intending to deliver the right support on the right occasion. As a novel strategy for delivering mobile health interventions, JITAIs have the potential to improve access to quality care in underserved communities and, thus, alleviate health disparities, a significant public health concern.
Valid experimental designs and analysis methods are required to inform the development of JITAIs. Here, we briefly review the cutting-edge design of microrandomized trials (MRTs), covering both the classical MRT design and its outcome-adaptive counterpart.
Associated statistical challenges related to the design and analysis of MRTs are also discussed. Two case studies are provided to illustrate the aforementioned concepts and designs throughout the article. We hope our work leads to better design and application of JITAIs, advancing public health research and practice. (Am J Public Health. Published online ahead of print November 22, 2022:e1–e10. https://doi.org/10.2105/AJPH.2022.307150 )
Background:
Social distancing and stay-at-home orders are critical interventions to slow down person-to-person transmission of COVID-19. While these societal changes help contain the pandemic, they also have unintended negative consequences, including anxiety and depression. We developed StayWell, a daily skills-based SMS text messaging program, to mitigate COVID-19 related depression and anxiety symptoms among people who speak English and Spanish in the United States.
Objective:
This paper describes the changes in StayWell participants' anxiety and depression levels after 60 days of exposure to skills-based SMS text messages.
Methods:
We used self-administered, empirically supported web-based questionnaires to assess the demographic and clinical characteristics of StayWell participants. Anxiety and depression were measured using the 2-item Generalized Anxiety Disorder (GAD-2) scale and the 8-item Patient Health Questionnaire-8 (PHQ-8) scale at baseline and 60-day timepoints. We used two-tailed paired t-tests to detect the change in PHQ-8 and GAD-2 scores from baseline to follow-up measured 60 days later.
Results:
The analytic sample includes 193 participants who completed both the baseline and 60-day exit questionnaires. At the 60-day time point, there were statistically significant reductions in both PHQ-8 and GAD-2 scores from baseline. We found an average reduction of -1.72 (95% CI: -2.35, -1.09) in PHQ-8 scores and -0.48 (95% CI: -0.71, -0.25) in GAD-2 scores. These improvements translated to an 18.5% and 17.2% reduction in mean PHQ-8 scores and GAD-2, respectively.
Conclusions:
StayWell is an accessible, low-intensity population-level mental health intervention. Participation in StayWell focused on COVID-19 mental health coping skills and was related to improved depression and anxiety symptoms. In addition to improvements in outcomes, we found high levels of engagement during the 60-day intervention period. Text messaging interventions could serve as an important public health tool for disseminating strategies to manage mental health.
Clinicaltrial:
ClinicalTrials.gov Identifier: NCT04473599.
International registered report:
RR2-10.2196/23592.
