Improving Outcomes in Depression in Primary Care in a Low Resource Setting

Summary

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.

Timeline

Start

2024-03-18

Primary completion

2026-04-10

Completion

2026-12-31

Publications

• Background Weobong B, Weiss HA, McDaid D, Singla DR, Hollon SD, Nadkarni A, Park AL, Bhat B, Katti B, Anand A, Dimidjian S, Araya R, King M, Vijayakumar L, Wilson GT, Velleman R, Kirkwood BR, Fairburn CG, Patel V. Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial. PLoS Med. 2017 Sep 12;14(9):e1002385. doi: 10.1371/journal.pmed.1002385. eCollection 2017 Sep.
• Pozuelo JR, Lahiri A, Singh RSP, Kushwah A, Khanduri M, Shukla A, Khan A, G S, Shende V, Parashar Y, Mehra YK, Bhan A, Kessler RC, Singla DR, Naslund JA, Choi KW, Cuijpers P, DeRubeis R, Herzallah MM, Lu C, Smoller JW, VanderWeele TJ, Rozatkar AR, Modak T, Joel MM, Biswas D, Atal S, Kulsum U, Hollon SD, Patel V. 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. 2025 Jul 30;25(1):744. doi: 10.1186/s12888-025-07030-9.
• Pozuelo JR, Lahiri A, Singh RSP, Kushwah A, Khanduri M, Shukla A, Khan A, G S, Shende V, Parashar Y, Mehra YK, Bhan A, Kessler RC, Singla DR, Naslund JA, Choi K, Cuijpers P, DeRubeis R, Herzallah M, Lu C, Smoller JW, VanderWeele TJ, Rozatkar A, Joel MM, Biswas D, Atal S, Kulsum U, Hollon SD, Patel V. Optimizing Treatment for Depression in Primary Care Using Psychotherapy Versus Antidepressant Medication in a Low-Resource Setting: Protocol for the OptimizeD Randomized Controlled Trial. Res Sq [Preprint]. 2025 May 23:rs.3.rs-6716211. doi: 10.21203/rs.3.rs-6716211/v1.

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Indications