Feasibility of a Behavioral Activation Trial

Feasibility of a Behavioral Activation Trial

 

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 who score 14 or above on the 17-item Hamilton Rating Scale for Depression (HAM-D) 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.

 

Eligibility
 

Ages Eligible for Study:  

18 Years and older   (Adult, Senior)

Sexes Eligible for Study:  

All

Accepts Healthy Volunteers:  

No

Criteria

Inclusion Criteria:

  1. baseline score ≥ 14 on the 17-item HAM-D,
  2. confirmed diagnosis of MDD based on the SCID for DSM-IV (or DSM-V, if available),
  3. ability to read at least at the 4th grade level,
  4. willingness to participate in research,
  5. 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

 

 Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. 

Please refer to this study by its ClinicalTrials.gov identifier: NCT02992158
 

Contacts

Contact: Paul Crits-Christoph, Ph.D.

2156627993

crits@mail.med.upenn.edu

 

Locations

United States, Pennsylvania

University of Pennsylvania

Recruiting

PhiladelphiaPennsylvaniaUnited States, 19104

Contact: Paul Crits-Christoph, Ph.D.    215-662-7993    crits@mail.med.upenn.edu   

Sponsors and Collaborators

University of Pennsylvania

NHS Human Services