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Web-Based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression (The eMotion Study): Pilot Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Physical activity is a potentially effective treatment for depression and depressive relapse. However, promoting physical activity in people with depression is challenging. Interventions informed by theory and evidence are therefore needed to support people with depression to become more physically active. eMotion is a Web-based intervention combining behavioral activation and physical activity promotion for people in the community with symptoms of depression. OBJECTIVE:The objectives were to assess the feasibility and acceptability of delivering eMotion to people in the community with symptoms of depression and to explore outcomes. METHODS:Participants with elevated depressive symptoms were recruited from the community through various methods (eg, social media) and randomized to eMotion or a waiting list control group for 8 weeks. eMotion is an administratively supported weekly modular program that helps people use key behavior change techniques (eg, graded tasks, action planning, and self-monitoring) to re-engage in routine, pleasurable, and necessary activities, with a focus on physical activities. Feasibility data were collected that included the following: recruitment and trial retention rates; fidelity of intervention delivery, receipt, and enactment; and acceptability of the intervention and data collection procedures. Data were collected for the primary (depression) and secondary outcomes (eg, anxiety, physical activity, fidelity, and client satisfaction) at baseline and 2 months postrandomization using self-reported Web-based questionnaires and accelerometers. Delivery fidelity (logins, modules accessed, time spent) was tracked using Web usage statistics. Exploratory analyses were conducted on the primary and secondary outcomes. RESULTS:Of the 183 people who contacted the research team, 62 were recruited and randomized. The mean baseline score was 14.6 (SD 3.2) on the 8-item Patient Health Questionnaire depression scale (PHQ-8). Of those randomized, 52 participants provided accelerometer-recorded physical activity data at baseline that showed a median of 35.8 (interquartile range [IQR] 0.0-98.6) minutes of moderate-to-vigorous physical activity (MVPA) recorded in at least 10-minute bouts per week, with only 13% (7/52) people achieving guideline levels (150 minutes of MVPA per week). In total, 81% (50/62) of participants provided follow-up data for the primary outcome (PHQ-8), but only 39% (24/62) provided follow-up accelerometer data. Within the intervention group, the median number of logins, modules accessed, and total minutes spent on eMotion was 3 (IQR 2.0-8.0), 3 (IQR 2.0-5.0), and 41.3 (IQR 18.9-90.4), respectively. Acceptability was mixed. Exploratory data analysis showed that PHQ-8 levels were lower for the intervention group than for the control group at 2 months postrandomization (adjusted mean difference -3.6, 95% CI -6.1 to -1.1). CONCLUSIONS:It was feasible to deliver eMotion in UK communities to inactive populations. eMotion has the potential to be effective and is ready for testing in a full-scale trial. Further work is needed to improve engagement with both the intervention and data collection procedures. TRIAL REGISTRATION:ClinicalTrials.gov NCT03084055; https://clinicaltrials.gov/ct2/show/NCT03084055 (Archived by WebCite at http://www.webcitation.org/6zoyM8UXa).

SUBMITTER: Lambert JD

PROVIDER: S-EPMC6066639 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Web-Based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression (The eMotion Study): Pilot Randomized Controlled Trial.

Lambert Jeffrey D JD Greaves Colin J CJ Farrand Paul P Price Lisa L Haase Anne M AM Taylor Adrian H AH

Journal of medical Internet research 20180716 7

<h4>Background</h4>Physical activity is a potentially effective treatment for depression and depressive relapse. However, promoting physical activity in people with depression is challenging. Interventions informed by theory and evidence are therefore needed to support people with depression to become more physically active. eMotion is a Web-based intervention combining behavioral activation and physical activity promotion for people in the community with symptoms of depression.<h4>Objective</h4 ...[more]

PMID: 30012547

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Project description:BackgroundWeb-based interventions have been shown to be effective for the treatment of depression. However, interventions are often complex and include a variety of elements, making it difficult to identify the most effective component(s).ObjectiveThe aim of this pilot study was to shed light on mechanisms in the online treatment of depression by comparing a single-module, fully automated intervention for depression (internet-based behavioral activation [iBA]) to a nonoverlapping active control intervention and a nonactive control group.MethodsWe assessed 104 people with at least mild depressive symptoms (Patient Health Questionnaire-9, >4) via the internet at baseline (t0) and 2 weeks (t1) and 4 weeks (t2) later. After the t0 assessment, participants were randomly allocated to one of three groups: (1) iBA (n=37), (2) active control using a brief internet-based mindfulness intervention (iMBI, n=32), or (3) care as usual (CAU, n=35). The primary outcome was improvement in depressive symptoms, as measured using the Patient Health Questionnaire-9. Secondary parameters included changes in activity, dysfunctional attitudes, and quality of life.ResultsWhile groups did not differ regarding the change in depression from t0 to t1 (ηp2=.007, P=.746) or t0 to t2 (ηp2=.008, P=.735), iBA was associated with a larger decrease in dysfunctional attitudes from t0 to t2 in comparison to CAU (ηp2=.053, P=.04) and a larger increase in activity from t0 to t1 than the pooled control groups (ηp2=.060, P=.02). A change in depression from t0 to t2 was mediated by a change in activity from t0 to t1. At t1, 22% (6/27) of the participants in the iBA group and 12% (3/25) of the participants in the iMBI group indicated that they did not use the intervention.ConclusionsAlthough we did not find support for the short-term efficacy of the single-module iBA regarding depression, long-term effects are still conceivable, potentially initiated by changes in secondary outcomes. Future studies should use a longer intervention and follow-up interval.Trial registrationDKRS (#DRKS00011562).

Project description:BackgroundDepression is the most prevalent mental health condition in older adults. However, not all evidence-based treatments are easily accessible. Web-delivered cognitive behavioral therapy (wCBT) facilitated by laypersons is a viable treatment alternative.ObjectiveThis randomized controlled trial aims to evaluate the efficacy of a novel wCBT program, Empower@Home, supported by trained lay coaches, against a waitlist attention control. Empower@Home is among the very few existing wCBT programs specifically designed for older adults. The primary objective was to assess the efficacy of the intervention compared with attention control. The secondary objective was to evaluate the program's impact on secondary psychosocial outcomes and explore potential change mechanisms.MethodsOlder adults (N=70) were recruited via web-based research registries, social media advertisements, and community agency referrals and randomly assigned to either the intervention or control group in a 1:1 allocation ratio. The intervention group received access to Empower@Home, which included 9 web-delivered self-help lessons and weekly telephone coaching sessions by a trained layperson over 10 weeks. The control group received weekly friendly phone calls and depressive symptom monitoring. The primary clinical outcome was the severity of depressive symptoms assessed using the Patient Health Questionnaire-9. The secondary clinical outcomes included anxiety, anger, social isolation, insomnia, pain intensity, and quality of life. Linear mixed modeling was used to determine the treatment effects on depression, and 2-tailed t tests were used to assess within-group changes and between-group differences.ResultsMost participants in the intervention group completed all 9 sessions (31/35, 89%). The usability and acceptability ratings were excellent. The intervention group had a large within-group change in depressive symptoms (Cohen d=1.22; P<.001), whereas the attention control group experienced a medium change (Cohen d=0.57; P<.001). The between-group effect size was significant, favoring the intervention group over the control group (Cohen d=0.72; P<.001). In the linear mixed model, the group-by-time interaction was statistically significant (b=-0.68, 95% CI -1.00 to -0.35; P<.001). The treatment effects were mediated by improvements in cognitive behavioral therapy skills acquisition; behavioral activation; and satisfaction with the basic psychological needs of autonomy, competence, and relatedness. Furthermore, the intervention group showed significant within-group improvements in secondary psychosocial outcomes, including anxiety (P=.001), anger (P<.001), social isolation (P=.02), insomnia (P=.007), and pain (P=.03). By contrast, the control group did not experience significant changes in these outcome domains. However, the between-group differences in secondary outcomes were not statistically significant, owing to the small sample size.ConclusionsEmpower@Home, a wCBT program supported by lay coaches, was more efficacious in reducing depressive symptoms than friendly telephone calls and depression symptom monitoring. Future studies should examine the effectiveness of the intervention in community and practice settings using nonclinician staff already present in these real-world settings as coaches.Trial registrationClinicalTrials.gov NCT05593276; https://clinicaltrials.gov/ct2/show/NCT05593276.International registered report identifier (irrid)RR2-10.2196/44210.

Project description:BACKGROUND:Psychological interventions for the prevention of depression might be a cost-effective way to reduce the burden associated with depressive disorders. OBJECTIVE:To evaluate the cost-effectiveness of a Web-based guided self-help intervention to prevent major depressive disorder (MDD) in people with subthreshold depression (sD). METHODS:A pragmatic randomized controlled trial was conducted with follow-up at 12 months. Participants were recruited from the general population via a large statutory health insurance company and an open access website. Participants were randomized to a Web-based guided self-help intervention (ie, cognitive-behavioral therapy and problem-solving therapy assisted by supervised graduate students or health care professionals) in addition to usual care or to usual care supplemented with Web-based psycho-education (enhanced usual care). Depression-free years (DFYs) were assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Costs were self-assessed through a questionnaire. Costs measured from a societal and health care perspective were related to DFYs and quality-adjusted life years (QALYs). RESULTS:In total, 406 participants were enrolled in the trial. The mean treatment duration was 5.84 (SD 4.37) weeks. On average, participants completed 4.93 of 6 sessions. Significantly more DFYs were gained in the intervention group (0.82 vs 0.70). Likewise, QALY health gains were in favor of the intervention, but only statistically significant when measured with the more sensitive SF-6D. The incremental per-participant costs were €136 (£116). Taking the health care perspective and assuming a willingness-to-pay of €20,000 (£17,000), the intervention's likelihood of being cost-effective was 99% for gaining a DFY and 64% or 99% for gaining an EQ-5D or a SF-6D QALY. CONCLUSIONS:Our study supports guidelines recommending Web-based treatment for sD and adds that this not only restores health in people with sD, but additionally reduces the risk of developing a MDD. Offering the intervention has an acceptable likelihood of being more cost-effective than enhanced usual care and could therefore reach community members on a wider scale. TRIAL REGISTRATION:German Clinical Trials Register: DRKS00004709; http://www.drks.de/DRKS00004709 (Archived by WebCite at http://www.webcitation.org/6kAZVUxy9).

Project description:BACKGROUND:Insufficient physical activity in the adult population is a global pandemic. Fun for Wellness (FFW) is a self-efficacy theory- and Web-based behavioral intervention developed to promote growth in well-being and physical activity by providing capability-enhancing opportunities to participants. OBJECTIVE:This study aimed to evaluate the effectiveness of FFW to increase physical activity in adults with obesity in the United States in a relatively uncontrolled setting. METHODS:This was a large-scale, prospective, double-blind, parallel-group randomized controlled trial. Participants were recruited through an online panel recruitment company. Adults with overweight were also eligible to participate, consistent with many physical activity-promoting interventions for adults with obesity. Also consistent with much of the relevant literature the intended population as simply adults with obesity. Eligible participants were randomly assigned to the intervention (ie, FFW) or the usual care (ie, UC) group via software code that was written to accomplish equal allocations to the FFW and UC groups. Data collection was Web based, fully automated, and occurred at three time points: baseline, 30 days after baseline (T2), and 60 days after baseline (T3). Participants (N=461) who were assigned to the FFW group (nFFW=219) were provided with 30 days of 24-hour access to the Web-based intervention. A path model was fit to the data consistent with the FFW conceptual model for the promotion of physical activity. RESULTS:There was evidence for a positive direct effect of FFW on transport-related physical activity self-efficacy (beta=.22, P=.02; d=0.23), domestic-related physical activity self-efficacy (beta=.22, P=.03; d=0.22), and self-efficacy to regulate physical activity (beta=.16, P=.01; d=0.25) at T2. Furthermore, there was evidence for a positive indirect effect of FFW on physical activity at T3 through self-efficacy to regulate physical activity at T2 (beta=.42, 95% CI 0.06 to 1.14). Finally, there was evidence for a null direct effect of FFW on physical activity (beta=1.04, P=.47; d=0.07) at T3. CONCLUSIONS:This study provides some initial evidence for both the effectiveness (eg, a positive indirect effect of FFW on physical activity through self-efficacy to regulate physical activity) and the ineffectiveness (eg, a null direct effect of FFW on physical activity) of the FFW Web-based behavioral intervention to increase physical activity in adults with obesity in the United States. More broadly, FFW is a scalable Web-based behavioral intervention that may effectively, although indirectly, promote physical activity in adults with obesity and therefore may be useful in responding to the global pandemic of insufficient physical activity in this at-risk population. Self-efficacy to regulate physical activity appears to be a mechanism by which FFW may indirectly promote physical activity in adults with obesity. TRIAL REGISTRATION:ClinicalTrials.gov, identifier: NCT03194854; https://clinicaltrials.gov/ct2/show/NCT03194854.

Project description:BACKGROUND:Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion. OBJECTIVE:The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention. METHODS:This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources. RESULTS:The project was funded in August 2014, and data collection was completed in May 2018. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. CONCLUSIONS:Findings from this investigation will enable us to develop an optimal package of intervention content and enhancement strategies for individuals with elevated symptoms of depression. If this intervention proves to be effective, it will provide a cost-effective, anonymous, appealing, and flexible approach for reducing symptoms of depression and improving psychological adjustment through increasing positive emotion. TRIAL REGISTRATION:ClinicalTrials.gov NCT01964820 (Phase 1); https://clinicaltrials.gov/ct2/show/NCT01964820 (Archived by WebCite at http://www.webcitation.org/6zpmKBcyX). ClinicalTrials.gov NCT02861755 (Phase 2); https://clinicaltrials.gov/ct2/show/NCT02861755 (Archived by WebCite at http://www.webcitation.org/6zpmLmy8k). REGISTERED REPORT IDENTIFIER:RR1-10.2196/10494.

Project description:BackgroundInteractive web-based physical activity interventions using Web 2.0 features (e.g., social networking) have the potential to improve engagement and effectiveness compared to static Web 1.0 interventions. However, older adults may engage with Web 2.0 interventions differently than younger adults. The aims of this study were to determine whether an interaction between intervention (Web 2.0 and Web 1.0) and age group (<55y and ≥55y) exists for website usage and to determine whether an interaction between intervention (Web 2.0, Web 1.0 and logbook) and age group (<55y and ≥55y) exists for intervention effectiveness (changes in physical activity).MethodsAs part of the WALK 2.0 trial, 504 Australian adults were randomly assigned to receive either a paper logbook (n = 171), a Web 1.0 (n = 165) or a Web 2.0 (n = 168) physical activity intervention. Moderate to vigorous physical activity was measured using ActiGraph monitors at baseline 3, 12 and 18 months. Website usage statistics including time on site, number of log-ins and number of step entries were also recorded. Generalised linear and intention-to-treat linear mixed models were used to test interactions between intervention and age groups (<55y and ≥55y) for website usage and moderate to vigorous physical activity changes.ResultsTime on site was higher for the Web 2.0 compared to the Web 1.0 intervention from baseline to 3 months, and this difference was significantly greater in the older group (OR = 1.47, 95%CI = 1.01-2.14, p = .047). Participants in the Web 2.0 group increased their activity more than the logbook group at 3 months, and this difference was significantly greater in the older group (moderate to vigorous physical activity adjusted mean difference = 13.74, 95%CI = 1.08-26.40 min per day, p = .03). No intervention by age interactions were observed for Web 1.0 and logbook groups.ConclusionsResults partially support the use of Web 2.0 features to improve adults over 55 s' engagement in and behaviour changes from web-based physical activity interventions.Trial registrationACTRN ACTRN12611000157976 , Registered 7 March 2011.

Project description:BackgroundPhysical activity levels after bariatric surgery are usually low, despite the significant protective health benefits of physical activity in this population. Positive psychological well-being is associated with improved adherence to health behaviors, but bariatric surgery patients often have negative associations with physical activity that prevent sustained engagement.ObjectiveThe Gaining Optimism After weight Loss Surgery (GOALS) pilot randomized controlled trial is aimed at testing a novel intervention to increase physical activity after bariatric surgery, which incorporates positive psychological skill-building with motivational interviewing and goal-setting.MethodsThe GOALS trial is a 2-arm, 24-week pilot randomized controlled trial that aims to enroll 58 adults who report less than 200 minutes per week of moderate to vigorous physical activity and a desire to become more active 6-12 months after bariatric surgery. GOALS is testing the feasibility, acceptability, and preliminary efficacy of a positive psychology-motivational interviewing telephone intervention targeting to increase physical activity and associated positive affect. Intervention components include positive psychology, goal-setting, self-monitoring via provided Fitbits, and motivational interviewing to overcome barriers and increase motivation. The intervention is compared to a physical activity education control that includes mailings with psychoeducation around physical activity and provision of a Fitbit. The primary outcomes of the pilot trial are feasibility and acceptability, measured as session completion rates and participant ratings of ease and helpfulness of each session. The main secondary outcome is change in accelerometer-measured moderate to vigorous physical activity post intervention and at 24-week follow-up. Additional outcomes include changes in attitudes related to physical activity, psychological well-being, and physical health measures.ResultsThis multiphase project was funded in 2020 and institutional review board approval was obtained for the proposed trial in 2021. Recruitment for the randomized controlled trial began in July 2022. Upon completion of the pilot trial, we will examine the feasibility, acceptability, and preliminary efficacy of the intervention.ConclusionsAlthough bariatric surgery is the most effective treatment available for severe obesity, weight regain occurs, often in the context of low psychological well-being. Many individuals would benefit from learning strategies to increase positive psychological well-being after bariatric surgery, which could help them maintain lifestyle changes. Positive psychology is a novel approach to improve adherence by increasing positive associations with health behaviors including physical activity. The GOALS pilot trial will determine whether this type of intervention is feasible and acceptable to this population and will provide a foundation for a future full-scale randomized controlled efficacy trial.Trial registrationClinicalTrials.gov NCT04868032; https://clinicaltrials.gov/ct2/show/NCT04868032.International registered report identifier (irrid)PRR1-10.2196/39856.

Project description:BackgroundDiabetes mellitus is a major health problem among people with physical disabilities. Health coaching has been proven to be an effective approach in terms of behavioral changes, patient self-efficacy, adherence to treatment, health service use, and health outcomes. Telehealth systems combined with health coaching have the potential to improve the quality of health care by increasing access to services. Treatment fidelity is particularly important for behavior change studies; however, fidelity protocols are inadequately administered and reported in the literature.ObjectiveThe aim of this study is to outline all the intervention fidelity strategies and procedures of a telecoaching intervention-artificial intelligence for diabetes management (AI4DM)-which is a randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with type 2 diabetes and permanent impaired mobility. AI4DM aims to create a web-based disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to ensure intervention fidelity in our research.MethodsWe have developed fidelity strategies based on the five fidelity domains outlined by the NIH BCC-focusing on study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. The design of the study is grounded in the social cognitive theory and is intended to ensure that both arms would receive the same amount of attention from the intervention. All providers will receive standardized training to deliver consistent health coaching to the participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within and between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among individuals with low health literacy. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure that participants use cognitive and behavioral skills in real-world settings to engage in health behavior.ResultsEnrollment for AI4DM will begin in October 2021 and end in October 2022. The results of this study will be reported in late 2022.ConclusionsDeveloping and using fidelity protocols in behavior change studies is essential to ensure the internal and external validity of interventions. This study incorporates NIH BCC recommendations into an artificial intelligence embedded telecoaching platform for diabetes management designed for people with physical disabilities. The developed fidelity protocol can provide guidance for other researchers conducting telehealth interventions within behavioral health settings to present more consistent and reproducible research.Trial registrationClinicalTrials.gov NCT04927377; http://clinicaltrials.gov/ct2/show/NCT04927377.International registered report identifier (irrid)PRR1-10.2196/31695.

Dataset Information

Web-Based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression (The eMotion Study): Pilot Randomized Controlled Trial.

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Web-Based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression (The eMotion Study): Pilot Randomized Controlled Trial.

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