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Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial.

ABSTRACT: Background:Depression 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. Objective:The 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. Methods:Using 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. Results:We 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%). Conclusions:The 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 registration:ClinicalTrials NCT02045771, Registered January 22, 2014.

SUBMITTER: D'Elia A

PROVIDER: S-EPMC7206724 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial.

D'Elia Alessia A Bawor Monica M Dennis Brittany B BB Bhatt Meha M Litke Kathryn K McCabe Kathleen K Whattam Jeff J Garrick Laura L O'Neill Laura L Simons Scott S Chalmers Sandra S Key Brenda B Goyert Stefanie S Laplante Phillip P Vanstone Meredith M Xie Feng F Guyatt Gordon G Thabane Lehana L Samaan Zainab Z

Pilot and feasibility studies 20200507

<h4>Background</h4>Depression 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.<h4 ...[more]

PMID: 32411381

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Project description:BACKGROUND:Depression is associated with a loss of productivity and noticeable personal, social, and economic decline; it affects more than 350 million people worldwide. Behavioral activation (BA), derived from cognitive behavioral therapy, has drawn increasingly more interest as a means of treatment for major depressive disorder due to its relative cost-effectiveness and efficacy. In this study, we disseminate findings from a feasibility study evaluating barriers to implementing a group BA program for major depressive disorder. The purpose of this feasibility study is to assess both patient and clinician perceptions on components of a group-based behavioral activation (BA) program. In particular, this feasibility study provides in-depth evaluation of the acceptability of BA prior to the design and implementation of a randomized trial to investigate BA effectiveness. Findings from this study directly informed decisions regarding the design and implementation of BA during the pilot trial. Specific components of BA were assessed and modified based on the results of this study. METHODS:This qualitative study was completed through the Mood Disorders Program at St. Joseph's Healthcare Hamilton. The authors of this study used data from two focus group sessions, one consisting of an interdisciplinary group of clinicians working in the Mood Disorders Program, and the other of registered outpatients of the Mood Disorders Program with a confirmed clinical diagnosis of depression. The benefits of offering this program in a group format, mainly social skill development opportunities and the use of technology such as activity tracking device, smart phones, and tablets during the therapy sessions, are a major focus of both the clinician and patient groups. Both groups emphasized the importance of offering sustainable activation. RESULTS:Differences in opinions existed between staff and patient groups regarding the use of technology in the program, though ultimately it was agreed upon that technology could be useful as a therapeutic aid. All participants agreed that behavioral activation was essential to the development of positive habits and routines necessary for recovery from depression. Patients agreed the program looked sustainable and stressed the potential benefit for improving depressive symptoms. CONCLUSIONS:Discussions from clinician and patient-centered focus groups directly informed decisions regarding the design and implementation of BA during the pilot trial. Specific components of BA were assessed and modified based on the results of this study. These findings provide insight for clinicians providing behavioral activation programming, and will serve as a framework for the development of the Out of the Blues program, a group-based BA program to be piloted in the Mood Disorders Program at St. Joseph's Healthcare Hamilton. TRIAL REGISTRATION:Clinical Trials registration number NCT02045771.

Project description:BACKGROUND:Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants' feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. METHODS/DESIGN:Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants' feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. DISCUSSION:The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients' feedback. TRIAL REGISTRATION:Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14-042.

Project description:Rural African Americans are disproportionately exposed to numerous stressors such as poverty that place them at risk for experiencing elevated levels of depressive symptoms. Effective treatments for decreasing depressive symptoms exist, but rural African Americans often fail to receive adequate and timely care. Churches have been used to address physical health outcomes in rural African American communities, but few have focused primarily on addressing mental health outcomes. Our partnership, consisting of faith community leaders and academic researchers, adapted an evidence-based behavioral activation intervention for use with rural African American churches. This 8-session intervention was adapted to include faith-based themes, Scripture, and other aspects of the rural African American faith culture (e.g. bible studies) This manuscript describes a Hybrid-II implementation trial that seeks to test the effectiveness of the culturally adapted evidence-based intervention (Renewed and Empowered for the Journey to Overcome in Christ: REJOICE) and gather preliminary data on the strategies necessary to support the successful implementation of this intervention in 24 rural African American churches. This study employs a randomized one-way crossover cluster design to assess effectiveness in reducing depressive symptoms and gather preliminary data regarding implementation outcomes, specifically fidelity, associated with 2 implementation strategies: training only and training+coaching calls. This project has the potential to generate knowledge that will lead to improvements in the provision of mental health interventions within the rural African American community. Further, the use of the Hybrid-II design has the potential to advance our understanding of strategies that will support the implementation of and sustainability of mental health interventions within rural African American faith communities.Trial registrationNCT02860741. Registered August 5, 2016.

Project description:Up to 50% of patients undergoing hemodialysis suffer from symptoms of depression and/or anxiety. Access to traditional pharmacotherapies and psychotherapies for depression or anxiety in this patient population has been inadequate. The objective of this study was to investigate the feasibility and effectiveness of brief mindfulness meditation intervention for patients on hemodialysis with depression and anxiety symptoms.This study was a randomized, controlled, assessor-blinded trial conducted in an urban hemodialysis unit. Forty-one patients were randomly assigned to intervention (n=21) and treatment-as-usual (n=20) groups. The intervention group received an 8-week individual chairside meditation intervention lasting 10-15 minutes, three times a week during hemodialysis. Feasibility outcomes were primarily assessed: enrollment rates, intervention completion rates, and intervention tolerability. Symptoms of depression and anxiety were measured using the Patient Health Questionnaire (PHQ-9) and the General Anxiety Disorder-7 (GAD-7).Of those deemed eligible for the study, 67% enrolled (41 of 61). Of the participants randomized to the intervention group, 71% completed the study, with meditation being well tolerated (median rating of 8 of 10 in a Likert scale; interquartile range=10-5 of 10). Barriers to intervention delivery included frequent hemodialysis shift changes, interruptions by staff or alarms, space constraints, fluctuating participant medical status, and participant fatigue. Meditation was associated with subjective benefits but no statistically significant effect on depression scores (change in PHQ-9, -3.0±3.9 in the intervention group versus -2.0±4.7 in controls; P=0.45) or anxiety scores (change in GAD-7, -0.9±4.6 versus -0.8±4.8; P=0.91).On the basis of the results of this study, mindfulness meditation appears to be feasible and well tolerated in patients on hemodialysis with anxiety and depression symptoms. The study did not reveal significant effects of the interventions on depression and anxiety scores.This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2017_10_12_CJASNPodcast_17_12_.mp3.

Project description:The incidence of depression is higher in PLWH (people living with HIV) than in the general population. It is of clinical significance to explore effective measures to improve depression in patients. But the available evidence is still quite limited. CBT (cognitive behavioral therapy) is considered to be one of the effective methods to improve depression, medication adherence and quality of life in PLWH. Therefore, this study aimed to systematically evaluate the effect of cognitive behavioral therapy on improving depressive symptoms and increasing adherence to antiretroviral therapy (ART) in people living with HIV (Human Immunodeficiency Virus). The Cochrane Library, Embase, PubMed, and Web of Science databases were searched by computer to collect randomized controlled trials on the effects of cognitive behavioral therapy on improving depression and increasing ART medication adherence in PLWH, and the retrieval time was from the inception of each database to January 10, 2022. Meta-analysis was performed by two researchers using Stata 15.0 software after screening the literature, extracting data and evaluating quality according to inclusion and exclusion criteria. A total of 16 studies with 1,998 patients were included. Meta-analysis results showed that CBT improved depressive symptoms in PLWH (SMD = −0.09, 95% CI [−0.13 to −0.04], P < 0.001) with better long-term (<6 months) depression improvement (SMD = −0.09, 95% CI [−0.15 to −0.02], P = 0.006) than short-term (0–6 months); the difference in improved ART medication adherence in the CBT group compared to the control group was not statistically significant (SMD = 0.04, 95% CI [−0.06 to 0.13], P = 0.490). There may be publication bias due to incomplete inclusion of literature as only published literature was searched. Cognitive behavioral therapy is effective in improving depressive symptoms in people living with HIV, with better long-term (>6 months) results than short-term (0–6 months).

Project description:BackgroundThe effects of exercise frequency and intensity on alleviating depressive symptoms in older adults with insomnia are unclear.PurposeThe purpose of this study was to investigate the influence of different exercise frequencies and intensities on prescribed aerobic-type physical activity (i.e., 75 min of vigorous-intensity exercise or 150 min of moderate-intensity exercise weekly) for reducing depressive symptoms in older adults living with insomnia, as recommended by the WHO.DesignThis study is a randomized, controlled, assessor-blinded trial.SettingThis study is conducted at a single research site in Hong Kong.ParticipantsThis study includes older adults aged 50 years or above with depressive symptoms and insomnia.InterventionParticipants were randomly assigned in a 1:1:1:1:1 ratio to the following groups: attention control (CON), moderate walking once weekly (MOD × 1/week), moderate walking thrice weekly (MOD × 3/week), vigorous walking once weekly (VIG × 1/week), and vigorous walking thrice weekly (VIG × 3/week). The total weekly exercise volumes among the walking groups were matched to the minimum recommended physical activity volume.MeasurementsDepression, anxiety, self-perceived sleep quality, insomnia severity, actigraphy-assessed 7-day sleep data, 7-day sleep diary, cardiorespiratory fitness, adherence, and habitual physical activity were examined at baseline and after 12 weeks of intervention.ResultsBoth MOD × 3/week and VIG × 3/week groups demonstrated reduced depression (Hospital Anxiety and Depression Scale [HADS] - Depression: MOD × 3/wk: -68.6%; VIG × 3/week: -67.4%) and anxiety levels (HADS - Anxiety: MOD × 3/week: -54.3%; VIG × 3/week: -59.8%) compared with CON (both p < 0.01). Self-perceived sleep quality was improved in MOD × 3/week (-31.4% of the Pittsburgh Sleep Quality Index [PSQI]), VIG × 1/week (-34.1% of PSQI), and VIG × 3/week (-38.3% of PSQI), but not in MOD × 1/week, when compared with CON (p < 0.05). No serious adverse events were observed in this study.ConclusionThe effects of walking training on reducing depressive symptoms appeared to be dependent on exercise frequency. Our findings suggest that three sessions of walking per week at either moderate or vigorous-intensity effectively alleviate depressive symptoms in older adults with insomnia. Additional research is needed to further verify the effects of exercise frequency on depression.Clinical trial registration[ClinicalTrials.gov], identifier [NCT04354922].

Dataset Information

Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial.

Publications

Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial.

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