Feasibility of a Behavioral Activation Trial

Major Depressive Disorder Clinical Trial

Official title:

Feasibility of a Behavioral Activation Trial in Community Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992158
• Other study ID #: R34MH108818
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 2019

Study information

• Verified date: May 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• behavioral activation

• treatment-as-usual
psychotherapy (and potentially medication) as part of treatment-as-usual provided in a community mental health center

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Merakey Behavioral Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent of eligible patients who refuse randomization	We will calculate this value based on our records of patient participation in baseline assessments.	assessed at baseline
Primary	percent of patients who complete 9 sessions of BA treatment	We will calculate this value based on our records of patient attendance of therapy sessions (tracked each week by a research assistant).	12 weeks
Primary	percent of BA homework assignments that are completed	We will calculate this value based on our records of homework assignment completion (tracked weekly by therapist participants and reported to the research staff).	12 weeks
Primary	percent of monthly assessments obtained	We will calculate this value based on our records of patient assessment attendance (tracked by a research assistant).	12 weeks
Primary	Opinions About Treatment questionnaire	This questionnaire measures patient ratings of the credibility of BA treatment.	collected at week 2
Primary	Brief Alliance Inventory	This questionnaire measures patient ratings of the therapeutic alliance.	collected at weeks 2, 4, 6, and 8
Secondary	Behavioral Activation for Depression Scale		monthly for 3 months
Secondary	Reward Probability Index		monthly for 3 months
Secondary	Hamilton Rating Scale for Depression		monthly for 3 months
Secondary	Short Form Health Survey (SF-36)		monthly for 3 months
Secondary	Inventory of Depressive Symptomatology		monthly for 3 months
Secondary	Behavior and Symptom Identification Scale (BASIS-24)		monthly for 3 months
Secondary	Dysfunctional Attitudes Scale		monthly for 3 months
Secondary	Quality of Life Index (questionnaire)		monthly for 3 months
Secondary	Beck Anxiety Inventory		monthly for three months
Secondary	Effort Expenditure for Rewards Task (EEfRT)		administered once at baseline and once at month 3