1,500
Participants
Start Date
March 18, 2024
Primary Completion Date
June 30, 2026
Study Completion Date
March 31, 2027
Healthy Activity Program (HAP)
HAP, delivered over 6-8 sessions by non-specialist healthcare workers, has behavioural activation as the core psychological strategy along with other strategies such as problem-solving and activation of social networks.
Antidepressant medication (fluoxetine)
Patients assigned to antidepressant medication will start on fluoxetine 20 mg/day and can be raised to 40 mg/day (the maximum mandated by treatment guidelines for primary care in India) at week 3 or 6 for patients who have yet to remit. Participants who do not tolerate fluoxetine can be switched to escitalopram at week 6 (10mg which can be titrated up to 20 mg).
RECRUITING
Sangath, Bhopal
Sangath
OTHER
All India Institute of Medical Sciences, Bhopal
OTHER
Vanderbilt University
OTHER
Brigham and Women's Hospital
OTHER
Centre for Addiction and Mental Health
OTHER
Massachusetts General Hospital
OTHER
Harvard School of Public Health (HSPH)
OTHER
National Institute of Mental Health (NIMH)
NIH
Harvard Medical School (HMS and HSDM)
OTHER