Actively Recruiting
Improving Outcomes in Depression in Primary Care in a Low Resource Setting
Led by Harvard Medical School (HMS and HSDM) · Updated on 2025-11-05
1500
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
H
Harvard Medical School (HMS and HSDM)
Lead Sponsor
S
Sangath
Collaborating Sponsor
AI-Summary
What this Trial Is About
The OptimizeD study aims to improve outcomes in depression in primary care in India. This study will randomize 1500 patients with moderate to severe depression to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication (fluoxetine). The study has two primary objectives: 1. Use patient characteristics to generate a precision treatment rule based on baseline information for predicting in advance what works best for whom (and which patients are unlikely to respond to either treatment and should be referred to specialist care). 2. Conduct a cost-effectiveness analysis by comparing relative costs and effectiveness between those who were randomly allocated to their optimal treatment with those who were randomly allocated to a non-optimal treatment based on the precision treatment rule.
CONDITIONS
Official Title
Improving Outcomes in Depression in Primary Care in a Low Resource Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 or older of any gender
- Attending selected Primary Health Care Centers
- Diagnosed with moderate to severe depression based on a Patient Health Questionnaire-9 (PHQ-9) score of 10 or above
You will not qualify if you...
- Women who are pregnant or breastfeeding
- History of psychosis, including schizophrenia spectrum disorders or bipolar disorder
- Planning to permanently move out of the study area during follow-up
- Evidence of cognitive impairment
- Do not speak English or Hindi
- Undergoing treatment for depression at recruitment or completed treatment within one month prior
- At imminent risk for suicide
- Another household member already recruited in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sangath
Bhopal, Madhya Pradesh, India, 462016
Actively Recruiting
Research Team
J
Julia R Pozuelo, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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