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.

Eligibility

Inclusion Criteria:

* Participants will be adults aged 18 or over of any gender attending one of the selected Primary Health Care Centers with a "diagnosis" of moderate to severe depression based on scores of 10 or above on the Patient Health Questionnaire-9 (PHQ-9).

Exclusion Criteria:

1. Women who are pregnant or are breastfeeding or lactating
2. Patients with a history of psychosis, including schizophrenia spectrum disorders or bipolar disorder.
3. Participants planning to permanently move out of the study area during the follow-up period.
4. Patients with evidence of cognitive impairment.
5. Patients who do not speak either English or Hindi.
6. Patients who are undergoing treatment for depression at the time of recruitment or who completed treatment within one month prior to recruitment
7. Patients at imminent risk for suicide
8. Patients from households in which another member has been recruited into the study

Conditions2

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