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Completed

NCT Number: NCT02992158

Feasibility of a Behavioral Activation Trial

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Activation

Behavioral

Treatment-as-usual

Behavioral

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

Primary outcomes

  1. percent of eligible patients who refuse randomization

    Time frame: assessed at baseline

    We will calculate this value based on our records of patient participation in baseline assessments.

  2. percent of patients who complete 9 sessions of BA treatment

    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).

  3. percent of BA homework assignments that are completed

    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).

  4. percent of monthly assessments obtained

    Time frame: 12 weeks

    We will calculate this value based on our records of patient assessment attendance (tracked by a research assistant).

  5. Opinions About Treatment questionnaire

    Time frame: collected at week 2

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

  6. Brief Alliance Inventory

    Time frame: collected at weeks 2, 4, 6, and 8

    This questionnaire measures patient ratings of the therapeutic alliance.

Secondary outcomes

  1. Behavioral Activation for Depression Scale

    Time frame: monthly for 3 months

  2. Reward Probability Index

    Time frame: monthly for 3 months

  3. Hamilton Rating Scale for Depression

    Time frame: monthly for 3 months

  4. Short Form Health Survey (SF-36)

    Time frame: monthly for 3 months

  5. Inventory of Depressive Symptomatology

    Time frame: monthly for 3 months

  6. Behavior and Symptom Identification Scale (BASIS-24)

    Time frame: monthly for 3 months

  7. Dysfunctional Attitudes Scale

    Time frame: monthly for 3 months

  8. Quality of Life Index (questionnaire)

    Time frame: monthly for 3 months

  9. Beck Anxiety Inventory

    Time frame: monthly for three months

  10. Effort Expenditure for Rewards Task (EEfRT)

    Time frame: administered once at baseline and once at month 3

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Merakey Behavioral Health

Registry information

Official study title

Feasibility of a Behavioral Activation Trial in Community Mental Health

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2016
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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