Feasibility of a Behavioral Activation Trial

NCT02992158 | Completed DMC

• 1 other identifier: R34MH108818
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• Opinions About Treatment questionnaire

  This questionnaire measures patient ratings of the credibility of BA treatment.

  collected at week 2

• Brief Alliance Inventory

  This questionnaire measures patient ratings of the therapeutic alliance.

  collected at weeks 2, 4, 6, and 8

Secondary Outcomes (10)

• Behavioral Activation for Depression Scale

  monthly for 3 months

• Reward Probability Index

  monthly for 3 months

• Hamilton Rating Scale for Depression

  monthly for 3 months

• Short Form Health Survey (SF-36)

  monthly for 3 months

• Inventory of Depressive Symptomatology

  monthly for 3 months

Study Arms (2)

behavioral activation

EXPERIMENTAL

The core principles of the BA model are: (1) the key to changing how people feel is helping them change what they do, (2) changes in life can lead to depression, and short-term coping strategies may keep people stuck over time, (3) the clues to figuring out what will be antidepressant for a particular client lie in what precedes and follows the client's important behaviors, (4) structure and scheduling of activities should follow a plan, not a mood, (5) change will be easier when starting small, (6) activities that are naturally reinforcing should be emphasized, (7) the therapist should act as a coach, (8) a problem-solving empirical approach should be emphasized with recognition that all results are useful, (9) patients should be encourages to not just talk, do! (10) possible and actual barriers to activation should be examined. Patients can also receive medications in this arm.

Behavioral: behavioral activation

treatment-as-usual

OTHER

Patients will receive psychotherapy (and potentially medications) as part of treatment-as-usual provided in the CMHC setting.

Behavioral: treatment-as-usual

Interventions

behavioral activation BEHAVIORAL

behavioral activation

treatment-as-usual BEHAVIORAL

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

treatment-as-usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Merakey Behavioral Health: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 14, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: March 25, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)