OptimizeD
Improving Outcomes for Depression in Primary Care in Low Resource Settings
An ongoing project (2022-current).
The Aim of the Study:
OptimizeD, led by Dr. Vikram Patel (Harvard Medical School) and Steven Hollon (Vanderbilt University), aims to improve depression treatment outcomes in primary care in India. As part of the study, we will randomize 1,500 patients with moderate to severe depression to one of two treatments: psychotherapy based on behavioral activation (the Healthy Activity Program, HAP) or antidepressant medication (fluoxetine). The main goal is to develop a precision treatment rule using baseline patient data to predict in advance which individuals will benefit most from each treatment option. The team will also perform a cost-effectiveness analysis to determine if assigning patients to their optimal treatment is more cost-effective than random assignment.
The Background:
OptimizeD will be implemented in the Bhopal district, the capital city of Madhya Pradesh, a state in India. The recruitment sites will comprise 6–10 primary healthcare centers, selected from a larger pool of 21 facilities, to ensure diverse population representation.
The Project Plan:
The project will begin with a Pilot Trial, in which the team will develop and test the baseline assessment and all the trial procedures, including treatment delivery. The team has estimated that a sample of around 40 participants (i.e., 5 participants from approximately 8 health facilities) would provide sufficient information to refine the processes for the main trial.
The Pilot Trial will be followed by the Main Trial, in which 1,509 patients will be randomized to either the group receiving HAP or the group receiving antidepressants and will be treated for three months to achieve remission.
Supporters and Project Duration:
This study is funded by the National Institute of Mental Health, USA, and will run from 2022 to 2026.
For more information, visit: OptimizeD | Sangath
The NIH Clinical Trial Registration can be found here.
Findings:
The Pilot Trial has been completed. Recruitment of 1509 participants was completed on December 31, 2025. The protocol for the main trial was published in BMC Psychiatry (2025). A study on the development of a baseline battery to optimize treatment assignment was published in the Journal of Affective Disorders (2026). Visit the publications section below to learn more.
Next Steps:
The research team plans to complete the data collection for the three-month primary endpoint by March 31, 2026. Data collection for long-term follow-up up to 12 months will be completed by December 31, 2026.
Publications:
- March 2026: Development of a baseline battery to optimize depression treatment assignment in primary care: Balancing breadth and brevity. Journal of Affective Disorders.
- July 2025: Optimizing treatment for depression in primary care using psychotherapy versus antidepressant medication in a low-resource setting: protocol for the OptimizeD randomized controlled trial. BMC Psychiatry.
Investigators and Team Members:
Project Leadership
Principal Investigators:
Vikram Patel, MD, PhD
Paul Farmer Professor and Chair of the
Department of Global Health and Social Medicine,
Harvard Medical School
Steven Hollon, PhD
Gertrude Conaway Vanderbilt Professor of Psychology
Department of Psychology
Vanderbilt University
Site Principal Investigator:
Dr. Anant Bhan, MHSc, MBBS
Site PI, Sangath
Project Leads at Harvard Medical School:
John A. Naslund, PhD
Instructor in Global Health and Social Medicine
Department of Global Health and Social Medicine
Harvard Medical School
Julia R Pozuelo, PhD
Postdoctoral Fellow
Department of Global Health and Social Medicine
Harvard Medical School
Project Lead at AIIMS Bhopal:
Debasis Biswas, MBBS MD, PDC, MAMS,MNASc, FRC Path
Professor and Head of Microbiology, AIIMS
Intervention Coordinators:
Azaz Khan, MA, MSW, PGDHRD
Director of Training and Interventions, Sangath
Tamonud Moduk, MBBS, MD
Assistant Professor, Department of Psychiatry
AIIMS
Dr. Abhijit Rozatkar, MBBS, MD
Additional Professor, Department of Psychiatry
AIIMS
NIMH Program Officer:
Holly Campbell-Rosen, Ph.D.
Center for Global Mental Health Research
National Institute of Mental Health/ NIH
Key Collaborators (in alphabetical order)
Shubham Atal, MBBS, MSc, MD
Associate Professor, Department of Pharmacology
AIIMS
Karmel Choi, PhD
Assistant Professor of Psychology, Department of Psychiatry
Massachusetts General Hospital
Pim Cuijpers, PhD
Professor of Clinical Psychology, Department of Behavioural and Movement Sciences
Vrije Universiteit Amsterdam
Robert DeRubeis, PhD
Professor and Director of Clinical Training, Department of Psychology
University of Pennsylvania
Mohammad Herzallah, PhD
Research Scientist, Center for Molecular and Behavioral Neuroscience
Rutgers University
Ronald Kessler, PhD
McNeil Family Professor of Health Care Policy, Department of Health Care Policy
Harvard Medical School
Chunling Lu, PhD
Assistant Professor, Department of Medicine
Brigham and Women’s Hospital and Harvard Medical School
Daisy Singla, PhD
Assistant Professor, Department of Psychiatry
University of Toronto
Jordan Smoller, MD, SCD
Associate Chief for Research, Department of Psychiatry
Massachusetts General Hospital
Tyler VanderWeele, PhD
John L. Loeb and Frances Lehman Loeb Professor of Epidemiology, Department of Epidemiology
Havard T.H. Chan School of Public Health
Research Team (in alphabetical order)
Umay Kulsum, PhD
Research Scholar
AIIMS
Arvind Kushwah, MSW
Outcome Assessor Coordinator
Sangath
Anuja Lahiri, PhD
Trial Manager, OptimizeD
Sangath
Yashwant Mehra, PhD
Recruitment Supervisor
Sangath
Kathryn O'Neill, MPH
Research Manager, Mental Health For All Lab
Department of Global Health and Social Medicine, Harvard Medical School
Yashika Parashar, MBBS, MMSc
Research Assistant, Mental Health For All Lab
Department of Global Health and Social Medicine, Harvard Medical School
Varun Shende, MPH
Data Manager
Sangath
Akanksha Shukla, MA
HAP coordinator
Sangath
Rahul S.P. Singh, MPH
ADM cum Assistant Research Coordinator
Sangath