OptimizeD

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Improving Outcomes for Depression in Primary Care in Low Resource Settings



The Aim of the Project:
 

OptimizeD, led by Dr. Vikram Patel (Harvard Medical School) and Steven Hollon (Vanderbilt University) strives to discern the optimal treatment modality for individual patients grappling with moderate to severe depression. This will be achieved by determining which patients will do better on antidepressant medication versus behavioral activation psychotherapy (through the Healthy Activity Program), the two recommended treatments for depression in primary care, through a machine learning generated precision treatment rule utilizing baseline patient characteristics.

The Background:

The evident lack of psychiatrists in Madhya Pradesh, along with an increase in the prevalence of mental illnesses post-COVID-19 have broadened the pre-exisitng treatment gap. Lack of financial support, coupled with the higher prevalence of mental illnesses in lower socio-economic populations, along with a high economic burden for the affected families indicate a dire need for the development of cost-effective and accessible methods to provide mental health care to all. OptimizeD aims to provide a bottom-up approach to mental healthcare in Bhopal, Madhya Pradesh, integrating the basic structures of Indian healthcare systems into the delivery of mental health services.


The Project Plan:
 

OptimizeD will be implemented in the Bhopal district of Madhya Pradesh, India, in eight Primary Healthcare Centers (PHCs) ensuring the representation of urban, peri-urban and rural populations. Structured in two stages, this phase three 2-arm parallel randomized controlled trial begins with an initial 'Preparatory Stage' followed by the 'Main Trial'.

Preparatory Stage:


This stage is aimed at optimizing the assessment battery's acceptability and feasibility through a pilot study using both quantitative and qualitative metrics, such as duration, clarity, and cultural acceptability. Additionally, this stage involves training providers on the Healthy Activity Program (HAP) and PHC physicians on the Antidepressant Medication (ADM) protocol.

Main Trial:


1500 patients will be randomized to either HAP or ADM and treated for 3 months to achieve remission. Those who achieve remission enter a 9-month follow-up phase, during which HAP is gradually phased out while ADM continues, as is typical for each treatment. Patients in the HAP arm receive weekly sessions for 3 months and then discontinue, whereas patients in the ADM arm receive medication for the full 12 months. Patients who do not achieve remission or experience subsequent relapse (the return of the treated episode) are referred to specialist care.

Supporters and Project Duration:


This study receives its funding from the National Institute of Mental Health, USA, and spans from 2022 to 2026, underscoring a committed effort towards optimizing depression treatment methodologies.

For more information, visit: OptimizeD | Sangath
The NIH Clinical Trial Registration can be found here.
 

 

Project Leadership

 

Principal Investigators: 
Vikram Patel, MD, PhD 
The Pershing Square Professor of Global Health 
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, Bhopal, Madhya Pradesh, India

 

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 Ruiz 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, Bhopal, Madhya Pradesh, India

 

Intervention Coordinators:
Azaz Khan, MA, MSW, PGDHRD
Director of Training and Interventions
Sangath, Bhopal, Madhya Pradesh, India

 

Tamonud Moduk, MBBS, MD
Assistant Professor, Department of Psychiatry
AIIMS Bhopal, India 

 

Dr. Abhijit Rozatkar, MBBS, MD
Additional Professor, Department of Psychiatry
AIIMS Bhopal, India

 

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)

 

Karmel Choi, PhD
Assistant Professor of Psychology, Department of Psychiatry
Massachusetts General Hospital, USA

 

Pim Cuijpers, PhD
Professor of Clinical Psychology, Department of Behavioural and Movement Sciences
Vrije Universiteit Amsterdam, The Netherlands

 

Robert DeRubeis, PhD
Professor and Director of Clinical Training, Department of Psychology
University of Pennsylvania, USA

 

Mohammad Herzallah, PhD
Research Scientist, Center for Molecular and Behavioral Neuroscience
Rutgers University, USA

 

Ronald Kessler, PhD
McNeil Family Professor of Health Care Policy, Department of Health Care Policy
Harvard Medical School, USA

 

Chunling Lu, PhD 
Assistant Professor, Department of Medicine 
Brigham and Women’s Hospital and Harvard Medical School, USA

 

Daisy Singla, PhD 
Assistant Professor, Department of Psychiatry 
University of Toronto, Canada 

 

Jordan Smoller, MD, SCD
Associate Chief for Research, Department of Psychiatry
Massachusetts General Hospital, USA

 

Tyler VanderWeele, PhD
John L. Loeb and Frances Lehman Loeb Professor of Epidemiology, Department of Epidemiology
Havard T.H. Chan School of Public Health, USA

Research Team (in alphabetical order)

 
Shubham Atal, MBBS, MSc, MD
Associate Professor, Department of Pharmacology
AIIMS Bhopal, India

 

Namdeo Dongare, PhD
Data Manager
Sangath, Bhopal, India
namdeo.dongare@sangath.in
 

Madhurima Ghosh, MSc
Cost Evaluation Coordinator
Sangath, Bhopal, India
madhurima.ghosh@sangath.in
 

Umay Kulsum, PhD
Research Scholar
AIIMS, Bhopal, India

Arvind Kushwah, MSW
Outcome Assessor Coordinator
Sangath, Bhopal, India
arvind.kushwah@sangath.in
 

Anuja Lahiri, PhD
Trial Manager, OptimizeD
Sangath, Bhopal, India

 

Kathryn O'Neill, MPH
Research Manager, Mental Health For All Lab
Department of Global Health and Social Medicine, Harvard Medical School


Yashika Parashar
Research Assistant, Mental Health For All Lab
Department of Global Health and Social Medicine, Harvard Medical School
yashikaparashar@hms.harvard.edu


Rahul S.P. Singh, MPH
ADM cum Assistant Research Coordinator
Sangath, Bhopal, India
rahul.singh@sangath.in