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Feasibility of a Behavioral Activation Trial

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
behavioral activation
treatment-as-usual
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

behavioral activation

treatment-as-usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

percent of eligible patients who refuse randomization
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
We will calculate this value based on our records of patient attendance of therapy sessions (tracked each week by a research assistant).
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).
percent of monthly assessments obtained
We will calculate this value based on our records of patient assessment attendance (tracked by a research assistant).
Opinions About Treatment questionnaire
This questionnaire measures patient ratings of the credibility of BA treatment.
Brief Alliance Inventory
This questionnaire measures patient ratings of the therapeutic alliance.

Secondary Outcome Measures

Behavioral Activation for Depression Scale
Reward Probability Index
Hamilton Rating Scale for Depression
Short Form Health Survey (SF-36)
Inventory of Depressive Symptomatology
Behavior and Symptom Identification Scale (BASIS-24)
Dysfunctional Attitudes Scale
Quality of Life Index (questionnaire)
Beck Anxiety Inventory
Effort Expenditure for Rewards Task (EEfRT)

Full Information

First Posted
December 1, 2016
Last Updated
March 23, 2020
Sponsor
University of Pennsylvania
Collaborators
Merakey Behavioral Health
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1. Study Identification

Unique Protocol Identification Number
NCT02992158
Brief Title
Feasibility of a Behavioral Activation Trial
Official Title
Feasibility of a Behavioral Activation Trial in Community Mental Health
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Merakey Behavioral Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
behavioral activation
Arm Type
Experimental
Arm Description
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.
Arm Title
treatment-as-usual
Arm Type
Other
Arm Description
Patients will receive psychotherapy (and potentially medications) as part of treatment-as-usual provided in the CMHC setting.
Intervention Type
Behavioral
Intervention Name(s)
behavioral activation
Intervention Type
Behavioral
Intervention Name(s)
treatment-as-usual
Intervention Description
psychotherapy (and potentially medication) as part of treatment-as-usual provided in a community mental health center
Primary Outcome Measure Information:
Title
percent of eligible patients who refuse randomization
Description
We will calculate this value based on our records of patient participation in baseline assessments.
Time Frame
assessed at baseline
Title
percent of patients who complete 9 sessions of BA treatment
Description
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
Title
percent of BA homework assignments that are completed
Description
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
Title
percent of monthly assessments obtained
Description
We will calculate this value based on our records of patient assessment attendance (tracked by a research assistant).
Time Frame
12 weeks
Title
Opinions About Treatment questionnaire
Description
This questionnaire measures patient ratings of the credibility of BA treatment.
Time Frame
collected at week 2
Title
Brief Alliance Inventory
Description
This questionnaire measures patient ratings of the therapeutic alliance.
Time Frame
collected at weeks 2, 4, 6, and 8
Secondary Outcome Measure Information:
Title
Behavioral Activation for Depression Scale
Time Frame
monthly for 3 months
Title
Reward Probability Index
Time Frame
monthly for 3 months
Title
Hamilton Rating Scale for Depression
Time Frame
monthly for 3 months
Title
Short Form Health Survey (SF-36)
Time Frame
monthly for 3 months
Title
Inventory of Depressive Symptomatology
Time Frame
monthly for 3 months
Title
Behavior and Symptom Identification Scale (BASIS-24)
Time Frame
monthly for 3 months
Title
Dysfunctional Attitudes Scale
Time Frame
monthly for 3 months
Title
Quality of Life Index (questionnaire)
Time Frame
monthly for 3 months
Title
Beck Anxiety Inventory
Time Frame
monthly for three months
Title
Effort Expenditure for Rewards Task (EEfRT)
Time Frame
administered once at baseline and once at month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared via the Research Domain Criteria Database (RDoCdb), part of the NIMH Data Archive (NDA). All feasibility and outcome data will be shared.

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Feasibility of a Behavioral Activation Trial

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