This pilot study aims to explore and refine the trial procedures that will be implemented in
a larger-scale clinical trial scheduled to commence in March 2024 (NCT05944926). As part of
this study, 60 patients with moderate to severe depression will be randomized to either
psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or
antidepressant medication.
The pilot study has two primary objectives:
1. Evaluate the feasibility and acceptability of the study
2. Collect essential outcome data in preparation for the larger trial
Phase:
Phase 3
Details
Lead Sponsor:
Harvard Medical School (HMS and HSDM)
Collaborators:
All India Institute of Medical Sciences, Bhopal Brigham and Women's Hospital Centre for Addiction and Mental Health Harvard School of Public Health (HSPH) Massachusetts General Hospital National Institute of Mental Health (NIMH) Sangath Vanderbilt University