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

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.

Behavioral activation group therapy for reducing depressive symptoms and improving quality of life: a feasibility study.

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.

A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol.

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.

Further application of the care transitions intervention: results of a randomized controlled trial conducted in a fee-for-service setting.

The study objective was to test whether a self-care model for transitional care that has been demonstrated to improve outcomes in Medicare Advantage populations--The Care Transitions Intervention--could also improve outcomes in a Medicare fee-for-service population. Intervention patients were less likely to be readmitted to a hospital in general and for the same condition that prompted their index hospitalization at 30, 90, and 180 days versus control patients. Coaching chronically ill older patients and their caregivers to ensure that their needs are met during care transitions may reduce the rate of subsequent rehospitalization in a Medicare fee-for-service population.

Assessing the quality of transitional care: further applications of the care transitions measure.

BACKGROUND: The Institute of Medicine has identified care transitions as a priority area for performance measurement. OBJECTIVES: To examine the performance of the Care Transitions Measure (CTM) in more diverse populations and to introduce a 3-item CTM. RESEARCH DESIGN: Cross-sectional study with purposive sampling of traditionally underserved populations. Confirmatory factor analyses, internal consistency reliability analyses, and differential item function tests were performed to explore the stability and performance of the 15-item CTM. Regression assessed the ability of the 3-item CTM to predict the 15-item CTM total score. Analysis of variance tests were conducted to explore CTM performance in different populations with respect to health and demographics. SUBJECTS: A total of 225 patients age 18-90 who were hospitalized in the past 12 months and were African American, Hispanic American, or rural-dwelling. MEASURES: CTM-15, CTM-3, age, gender, education, and health status. RESULTS: Mplus confirmatory factor analysis supported the CTM-15 factor structure in more diverse population (Comparative Fit Index [CFI] = 0.954). The 3-item CTM explained 88% of the variance in the 15-item CTM score. Differential item function analysis did not reveal any differential item difficulty by age, gender, education, self-rated health, or group (African American, Hispanic American, and rural-dwelling). CONCLUSIONS: Following endorsement by National Quality Forum, findings support use of the CTM in national public reporting efforts. The 3-item CTM closely approximates the 15-item instrument and may be attractive to purchasers and health care organizations that want to assess quality in this area while minimizing cost and response burden.

The central role of performance measurement in improving the quality of transitional care.

The objectives of this study were: (1) to demonstrate the ability of the Care Transitions Measure (CTM) to identify care deficiencies; (2) to devise and implement a quality improvement approach designed to remedy these deficiencies; (3) to assess the impact of the quality improvement approach on CTM scores; and (4) to test whether the CTM-3 predicts return to the emergency department. The CTM was found to be a sensitive tool able to capture changes in performance. The 3-item CTM was found to significantly predict post-hospital return to the emergency department within the first 30 days (p = 0.004).

The care transitions intervention: results of a randomized controlled trial.

BACKGROUND: Patients with complex care needs who require care across different health care settings are vulnerable to experiencing serious quality problems. A care transitions intervention designed to encourage patients and their caregivers to assert a more active role during care transitions may reduce rehospitalization rates. METHODS: Randomized controlled trial. Between September 1, 2002, and August 31, 2003, patients were identified at the time of hospitalization and were randomized to receive the intervention or usual care. The setting was a large integrated delivery system located in Colorado. Subjects (N = 750) included community-dwelling adults 65 years or older admitted to the study hospital with 1 of 11 selected conditions. Intervention patients received (1) tools to promote cross-site communication, (2) encouragement to take a more active role in their care and to assert their preferences, and (3) continuity across settings and guidance from a "transition coach." Rates of rehospitalization were measured at 30, 90, and 180 days. RESULTS: Intervention patients had lower rehospitalization rates at 30 days (8.3 vs 11.9, P = .048) and at 90 days (16.7 vs 22.5, P = .04) than control subjects. Intervention patients had lower rehospitalization rates for the same condition that precipitated the index hospitalization at 90 days (5.3 vs 9.8, P = .04) and at 180 days (8.6 vs 13.9, P = .046) than controls. The mean hospital costs were lower for intervention patients ($2058) vs controls ($2546) at 180 days (log-transformed P = .049). CONCLUSION: Coaching chronically ill older patients and their caregivers to ensure that their needs are met during care transitions may reduce the rates of subsequent rehospitalization.