OptimizeD Pilot Study

• Status: Completed
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Antidepressive Agents

Criteria

Inclusion Criteria:

• Participants will be adults aged 18 or over of any gender attending one of eight Primary Health Care Centers with a "diagnosis" of moderate to severe depression based on scores of 10 or above on the Patient Health Questionnaire-9 (PHQ-9).

Exclusion Criteria:

• Women who are pregnant or are breastfeeding or lactating

• Patients with a history of psychosis including schizophrenia spectrum disorders or bipolar disorder.

• Participants planning to move out of the study area during the follow-up period.

• Patients over 65 years of age with evidence of cognitive impairment - Patients who do not speak the study or local language (English or Hindi)

• Patients who are undergoing treatment for depression at the time of recruitment