Feasibility of a Behavioral Activation Trial
Status: | Active, not recruiting |
---|---|
Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/20/2018 |
Start Date: | March 2016 |
End Date: | April 2019 |
Feasibility of a Behavioral Activation Trial in Community Mental Health
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.
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.
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.
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.
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
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-662-7993
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