Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial

摘要

Background Depression and anxiety disorders are common mental disorders worldwide. The MANAS trial aimed to test the eifectiveness of an intervention led by lay health counsellors in primary care settings to improve outcomes of people with these disorders. Methods In this cluster randomised trial, primary care facilities in Goa, India, were assigned (1:1) by computer-generated randomised sequence to intervention or control (enhanced usual care) groups. All adults who screened positive for common mental disorders were eligible. The collaborative stepped-care intervention offered case management and psychosocial interventions, provided by a trained lay health counsellor, supplemented by antidepressant drugs by the primary care physician and supervision by a mental health specialist. The research assessor was masked. The primary outcome was recovery from common mental disorders as defined by the International Statistical Classification of Diseases and Related Health Problems-10th revision (ICD-10) at 6 months. This study is registered with ClinicalTrials.gov, number NCT00446407.