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Feasibility of Pairing Behavioral Activation With Exercise for Women With Type 2 Diabetes and Depression: The Get It Study Pilot Randomized Controlled Trial.

ABSTRACT: Major depressive disorder is often comorbid with diabetes and associated with worse glycemic control. Exercise improves glycemic control and depression, and thus could be a parsimonious intervention for patients with comorbid diabetes and major depression. Because patients with diabetes and comorbid depression are often sedentary and lack motivation to exercise, we developed a group exercise intervention that integrates strategies from behavioral activation therapy for depression to increase motivation for and enjoyment of exercise. We conducted a 6-month pilot randomized controlled trial to test the feasibility of the behavioral activation exercise intervention (EX) for women with diabetes and depression. Of the 715 individuals who contacted us about the study, 29 participants were randomized to the EX condition or an enhanced usual care condition (EUC), which represents 4.1% of participants who initially contacted us. Inclusion criteria made recruitment challenging and limits the feasibility of recruiting women with diabetes and depression for a larger trial of the intervention. Retention was 96.5% and 86.2% at 3 and 6months. Participants reported high treatment acceptability; use of behavioral activation strategies and exercise class attendance was acceptable. No condition differences were observed for glycemic control, depressive symptoms, and physical activity, though depressive symptoms and self-reported physical activity improved over time. Compared to participants in the EUC condition, participants in the EX condition reported greater exercise enjoyment and no increase in avoidance behavior over time. Using behavioral activation strategies to increase exercise is feasible in a group exercise setting. However, whether these strategies can be delivered in a less intensive manner to a broader population of sedentary adults, for greater initiation and maintenance of physical activity, deserves further study.

SUBMITTER: Schneider KL

PROVIDER: S-EPMC4863641 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Feasibility of Pairing Behavioral Activation With Exercise for Women With Type 2 Diabetes and Depression: The Get It Study Pilot Randomized Controlled Trial.

Schneider Kristin L KL Panza Emily E Handschin Barbara B Ma Yunsheng Y Busch Andrew M AM Waring Molly E ME Appelhans Bradley M BM Whited Matthew C MC Keeney Jacey J Kern Daniel D Blendea Mihaela M Ockene Ira I Pagoto Sherry L SL

Behavior therapy 20151031 2

Major depressive disorder is often comorbid with diabetes and associated with worse glycemic control. Exercise improves glycemic control and depression, and thus could be a parsimonious intervention for patients with comorbid diabetes and major depression. Because patients with diabetes and comorbid depression are often sedentary and lack motivation to exercise, we developed a group exercise intervention that integrates strategies from behavioral activation therapy for depression to increase mot ...[more]

PMID: 26956652

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Project description:Depression is one of the most common psychological problems affecting individuals with type 1 diabetes, and it is associated with treatment nonadherence and worse clinical outcomes. The research on treating depression or nonadherence in adults with type 1 diabetes is limited. We adapted an evidence-supported treatment, individual cognitive-behavioral therapy for adherence and depression (CBT-AD), for type 1 diabetes and examined its feasibility, acceptability, and potential for an effect. The pilot study included 9 patients with a DSM-IV diagnosis of major depression, dysthymia, or residual depressive symptoms despite treatment with an antidepressant; a diagnosis of type 1 diabetes per patient self-report; and a glycosylated hemoglobin A1c (HbA1c) level of 8.0% or greater. Patients were referred by their diabetes care providers to a behavioral medicine specialty setting and received 10 to 12 sessions of CBT-AD. Main outcome measures included percent of eligible participants who enrolled in the study, session attendance, independently-rated Montgomery-Asberg Depression Rating Scale (MADRS) score, self-reported adherence to diabetes care activities, and adherence to self-monitoring of blood glucose levels. Data were collected from June 27, 2008, through March 31, 2010. There was a clinically meaningful decrease in depression severity (mean [SD] MADRS score decrease from 26.0 [4.73] to 12.3 [7.37], Cohen d = 2.90), demonstrated improvements in diabetes self-care (increase in blood glucose monitoring from 65.0 [26.72] to 82.7 [22.75], Cohen d = -0.66, and a difference in self-reported percent insulin doses in the past 2 weeks from 77.1 [29.84] to 87.1 [23.6], Cohen d = -0.34), and possible improvement in glycemic control (decrease in HbA1c levels from 9.6 [1.32] to 9.0 [1.04], Cohen d = 0.45). These preliminary results provide evidence for the acceptability, feasibility, and potential utility of CBT-AD for patients with type 1 diabetes and depression. clinicaltrials.gov Identifier: NCT01527981.

Project description:BackgroundThe increasing burden of depression and noncommunicable disease (NCD) is a global challenge, especially in low- and middle-income countries, considering the resource constraints and lack of trained human resources in these settings. Effective treatment of depression in people with NCDs has the potential to enhance both the mental and physical well-being of this population. It will also result in the effective use of the available health care resources. Brief psychological therapies, such as behavioral activation (BA), are effective for the treatment of depression. BA has not been adapted in the community health care services of India, and the feasibility of using BA as an intervention for depression in NCD and its effectiveness in these settings have not been systematically evaluated.ObjectiveOur objective is to adapt BA for the Indian NCD context and test the acceptability, feasibility, and implementation of the adapted BA intervention (BEACON intervention package [BIP]). Additionally, we aim to test the feasibility of a randomized controlled trial evaluation of BIP for the treatment of depression compared with enhanced usual care.MethodsFollowing well-established frameworks for intervention adaptation, we first adapted BA (to fit the linguistic, cultural, and resource context) for delivery in India. The intervention was also adapted for potential remote delivery by telephone. In a randomized controlled trial, we will be testing the acceptability, feasibility, and implementation of the adapted BA intervention (BIP). We shall also test if a randomized controlled feasibility trial can be delivered effectively and estimate important parameters (eg, recruitment and retention rates and completeness of follow-up) needed to design a future definitive trial.ResultsFollowing the receipt of approval from all the relevant agencies, the development of the BIP was started on November 28, 2020, and completed on August 18, 2021, and the quantitative data collection was started on August 23, 2021, and completed on December 10, 2021. Process evaluation (qualitative data) collection is ongoing. Both the qualitative and quantitative data analyses are ongoing.ConclusionsThis study may offer insights that could help in closing the gap in the treatment of common mental illness, particularly in nations with limited resources, infrastructure, and systems such as India. To close this gap, BEACON tries to provide BA for depression in NCDs through qualified NCD (BA) counselors integrated within the state-run NCD clinics. The results of this study may aid in understanding whether BA as an intervention is acceptable for the population and how feasible it will be to deliver such interventions for depression in NCD in South Asian countries such as India. The BIP may also be used in the future by Indian community clinics as a brief intervention program.Trial registrationClinical Trials Registry of India CTRI/2020/05/025048; https://tinyurl.com/mpt33jv5.International registered report identifier (irrid)DERR1-10.2196/41127.

Project description:BackgroundGroup Cognitive Behavioural Therapy (CBT) may provide a means of improving mental health among people with depression but few studies have explored its effectiveness. Our aim was to examine the feasibility and acceptability of a randomised controlled trial of a group intervention based on CBT principles for women with depression in primary care.MethodsWomen aged 30 to 55 years were recruited and randomly assigned to either 12 weeks of the group intervention or usual care (control). The group intervention was based on a manual and used CBT and problem solving principles with weekly topics including raising activity levels, spotting and catching negative thoughts, problem solving and relaxation. Women were recruited from deprived areas of Bristol. The groups were run by facilitators with some experience and background in group work and one weeks training in use of the course manual. Assessments of mental health were made using measures including the PHQ-9. Follow-up was at 3 and 6 months after the intervention. Qualitative methods were used to support the design of the intervention and to help understand issues of acceptability and feasibility. Interviews were conducted with all participants at baseline and at 3 and 6 months although detailed qualitative analysis was based on a purposive sample of 20 participants at the 3 time points.ResultsOf the 86 participants assessed for eligibility, 52 were allocated to the intervention arm and 21 to the control group. The intervention was delivered according to the manual despite the limited training of the facilitators. The intervention was received favourably by participants and facilitators, with good attendance at sessions for those who engaged with the intervention. Follow up rates at 3 and 6 months for women in both the intervention and control arms were also good. The trial methodology used was appropriate and feasible.ConclusionsThis study showed that a randomised controlled trial of group CBT for women with depression is feasible and the intervention is acceptable, and may possibly prove to be effective in a larger trial. The cost effectiveness of group CBT for depression should be explored further in a full trial.Trial registrationNCT00663078.

Project description:BackgroundDepression impacts the lives of millions of people worldwide. Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression. Studies evaluating the effectiveness of BA specifically in the context of group therapy programs in a hospital setting for patients with depression are limited. In this study, we report findings from a pilot trial evaluating group BA for major depressive disorder.ObjectiveThe objectives of this pilot trial are to assess the potential of a full trial of BA group therapy in a large-scale tertiary care setting and to provide preliminary information about possible results regarding mood symptoms and quality of life in adults with depression.MethodsUsing a parallel single-cohort pragmatic pilot randomized controlled trial design, we evaluated the potential of conducting a large trial of BA effectiveness among adults with depression. Participants were randomized to the intervention (BA in addition to usual care) or control (support group in addition to usual care) groups and were assessed weekly for 18 consecutive weeks. Participants randomized to intervention underwent 28 2-h group BA therapy visits administered by trained therapists and completed assessments to examine treatment outcomes. Feasibility was measured in terms of enrollment rates (min. 20%), completion rates of study (min. 80%), and completion rates of weekly measurement scales (min. 80%). The reporting of this pilot trial is in accordance with the CONSORT extension for randomized pilot and feasibility trials.ResultsWe randomized 20 individuals of mean age of 48.8 years (standard deviation = 9.7) with a DSM-5 diagnosis of major depressive disorder to intervention (n = 10) or control (n = 10) groups. Based on our feasibility criteria, our recruitment rate was excellent (20/27; 74%), study completion was found to be a moderate (80% of the total participants in both arms completed the study; BA = 100%, control = 60%), and completeness of measurements on a weekly basis was adequate overall (82%; BA = 86%, control = 79%).ConclusionsThe study has demonstrated the potential feasibility to perform a larger scale trial upon modifications to the control group to avoid the low rate of study completion (60%) in this group.Trial registrationClinicalTrials NCT02045771, Registered January 22, 2014.

Project description:BackgroundPhysical 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.ObjectiveThe objectives were to assess the feasibility and acceptability of delivering eMotion to people in the community with symptoms of depression and to explore outcomes.MethodsParticipants 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.ResultsOf 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).ConclusionsIt 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 registrationClinicalTrials.gov NCT03084055; https://clinicaltrials.gov/ct2/show/NCT03084055 (Archived by WebCite at http://www.webcitation.org/6zoyM8UXa).

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 a common mental health problem with significant personal and social consequences. Studies have suggested that cognitive behavioral therapy (CBT) is an effective treatment for depression and anxiety when delivered one-to-one by an expert practitioner, but access to this talking therapy is often limited, and waiting lists can be long. However, a range of low-intensity interventions that can increase access to services are available including guided CBT self-help materials delivered via books, classes, and online packages.ObjectiveThis project aimed to pilot a randomized controlled trial (RCT) of an online CBT-based life skills course with community-based individuals experiencing depression.MethodsIndividuals with symptoms of depression were recruited directly from the community via newspaper advertisements. Participants were remotely randomized to receive either immediate access (IA) or delayed access (DA) to a research version of the Living Life to the Full online CBT-based life skills package (3rd edition) with telephone support provided by nonspecialist, charity-based workers while they used the online intervention. The primary end point was at 3 months postrandomization, at which point, the DA group were offered the intervention. Levels of depression, anxiety, social functioning, and satisfaction were assessed.ResultsThere were effective recruitment, randomization, and uptake, with 19 IA and 17 DA control participants entering the pilot study via newspaper advertisements and 13 of the 19 participants taking up the intervention. Overall, 72% (26/36) were not currently under the care of their general practitioner. The online package was acceptable to participants; the mean satisfaction score on the Client Satisfaction Questionnaire was 21 out of 32 (SD 8.89). At 3 months, data collection was achieved from 78% (28/36) of the participants. The efficacy and retention data were used for a power calculation indicating that 72 participants in total will be required for a future substantive RCT.ConclusionsThe research design successfully tested the recruitment, data collection, and intervention delivery. The pilot study has provided data for the required sample size for the full RCT.Trial registrationISRCTN registry ISRCTN12890709; https://doi.org/10.1186/ISRCTN12890709.International registered report identifier (irrid)RR2-10.1186/s13063-016-1336-y.

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Feasibility of Pairing Behavioral Activation With Exercise for Women With Type 2 Diabetes and Depression: The Get It Study Pilot Randomized Controlled Trial.

Publications

Feasibility of Pairing Behavioral Activation With Exercise for Women With Type 2 Diabetes and Depression: The Get It Study Pilot Randomized Controlled Trial.

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