A Pilot Study of a Precision Treatment Trial Comparing Psychotherapy and Antidepressants for Depression in Indian Primary Care Settings

BackgroundDepression is commonly treated with either psychotherapy or antidepressants, but patients differ widely in their comparative responses. Identifying the most effective treatment for each individual is crucial to optimizing scarce resources. AimsTo evaluate the feasibility and acceptability of a precision treatment trial comparing psychotherapy based on behavioral activation (the Healthy Activity Program) with antidepressant medication (fluoxetine) in adults with depression in primary care settings in India. MethodsSingle-blind, two-arm randomized pilot trial in eight primary healthcare centers with adults (≥18 years) with moderate-severe depression (PHQ-9≥10). Primary outcomes assessed recruitment, retention, treatment adherence/fidelity, assessment completion, and safety procedures. Secondary outcomes included changes in depressive symptoms, remission, and patient-reported improvement at 3 months.ResultsOf 578 screened individuals, 76/180 eligible (42%) enrolled. Retention was 82% at 3 months. Psychotherapy participants attended 5.6/6-8 sessions, while medication participants consumed 57.9% of prescribed doses. Although assessment completion was high (72-100%), some measures proved burdensome, prompting refinements. Depressive symptoms improved across both arms, with 45.2% achieving remission. However, treatment responses varied substantially within each arm (psychotherapy: –9.1 [SD=6.5]; medication: –7.6 [SD=6.9]), indicating marked individual heterogeneity.ConclusionsThis pilot demonstrated the feasibility and acceptability of implementing a precision treatment trial for depression in Indian primary care and identified refinements to optimize procedures for the main trial. Both treatments improved symptoms, but the heterogeneity observed in each modality supports the potential for and importance of identifying the optimal treatment for each given patient.Trial registration: Registered at ClinicalTrials.gov (NCT06153004) on 22 November 2023.