University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT02992158
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
psychotherapy (and potentially medication) as part of treatment-as-usual provided in a community mental health center
Time frame: assessed at baseline
We will calculate this value based on our records of patient participation in baseline assessments.
Time frame: 12 weeks
We will calculate this value based on our records of patient attendance of therapy sessions (tracked each week by a research assistant).
Time frame: 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).
Time frame: 12 weeks
We will calculate this value based on our records of patient assessment attendance (tracked by a research assistant).
Time frame: collected at week 2
This questionnaire measures patient ratings of the credibility of BA treatment.
Time frame: collected at weeks 2, 4, 6, and 8
This questionnaire measures patient ratings of the therapeutic alliance.
Time frame: monthly for 3 months
Time frame: monthly for 3 months
Time frame: monthly for 3 months
Time frame: monthly for 3 months
Time frame: monthly for 3 months
Time frame: monthly for 3 months
Time frame: monthly for 3 months
Time frame: monthly for 3 months
Time frame: monthly for three months
Time frame: administered once at baseline and once at month 3
University of Pennsylvania
Other
Feasibility of a Behavioral Activation Trial in Community Mental Health
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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