Feasibility of a Behavioral Activation Trial

Not Applicable

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT02992158
• Lead Sponsor: University of Pennsylvania

Brief Summary

The goal of this project is to train community mental health therapists in behavioral activation (BA) treatment for major depressive disorder and then to conduct a study examining the feasibility of evaluating the effectiveness of BA in this setting.

Detailed Description

After finalizing a 9-session BA treatment model for major depressive disorder in the Community Mental Health Center (CMHC) setting, the final treatment manual will be used to train clinicians in BA at the CMHC through workshops and training cases.

Upon completion of training and certification of adequate implementation of BA, a total of 80 patients with MDD will be randomly assigned in a 3:1 ratio to 9 sessions of BA or treatment-as-usual (TAU) at the CMHC. Feasibility will be assessed in terms of (1) percent of eligible patients who refuse randomization, (2) percent of patients who complete 9 sessions of BA treatment, (3) percent of BA homework assignments that are completed, (4) percent of monthly assessments obtained, and (5) patient ratings of credibility and alliance in BA treatment. The ability of CMHC therapists to adequately implement BA will be assessed by rating taped sessions on BA adherence and competence scales. In addition to feasibility/acceptability of BA and TAU, this study is designed to test whether theoretically important targets of BA change over the course of BA treatment, and whether such changes are associated with changes in depressive symptoms. The target measures will be assessed at baseline, month 1, month 2, and month 3. To support the potential role of these targets as the mechanisms of change in BA, change in the target variables will be examined in relation to change in depression symptoms. The investigators will also pilot a potential moderator of treatment effects (trait reward processing, as measured at baseline using the Effort-Expenditure for Rewards Task) to include this potential moderator in a subsequent fully-powered study with the long-term goal of identifying the types of patients most responsive to BA.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-14
• Status Verified: 2019-05
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. confirmed diagnosis of MDD based on the SCID for DSM-IV (or DSM-V, if available),
2. ability to read at least at the 4th grade level,
3. willingness to participate in research,
4. willingness to be audio recorded (for both therapists and patient- participants)

Exclusion Criteria

1. current or past psychotic disorder, seizure disorder, or clinically significant organic pathology
2. acute medical problem requiring immediate inpatient treatment,
3. current substance abuse or dependence requiring primary referral to substance abuse program,
4. significant suicidal risk/ideation requiring immediate referral or suicidal gesture within the last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
percent of BA homework assignments that are completed	12 weeks	We will calculate this value based on our records of homework assignment completion (tracked weekly by therapist participants and reported to the research staff).
percent of eligible patients who refuse randomization	assessed at baseline	We will calculate this value based on our records of patient participation in baseline assessments.
percent of patients who complete 9 sessions of BA treatment	12 weeks	We will calculate this value based on our records of patient attendance of therapy sessions (tracked each week by a research assistant).
Opinions About Treatment questionnaire	collected at week 2	This questionnaire measures patient ratings of the credibility of BA treatment.
percent of monthly assessments obtained	12 weeks	We will calculate this value based on our records of patient assessment attendance (tracked by a research assistant).
Brief Alliance Inventory	collected at weeks 2, 4, 6, and 8	This questionnaire measures patient ratings of the therapeutic alliance.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Index (questionnaire)	monthly for 3 months
Effort Expenditure for Rewards Task (EEfRT)	administered once at baseline and once at month 3
Behavior and Symptom Identification Scale (BASIS-24)	monthly for 3 months
Dysfunctional Attitudes Scale	monthly for 3 months
Beck Anxiety Inventory	monthly for three months
Reward Probability Index	monthly for 3 months
Hamilton Rating Scale for Depression	monthly for 3 months
Behavioral Activation for Depression Scale	monthly for 3 months
Inventory of Depressive Symptomatology	monthly for 3 months
Short Form Health Survey (SF-36)	monthly for 3 months

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States