Effectiveness of an intervention led by lay health counsellors for XXXX and @entity148 in primary care in @entity24673 , India (MANAS): a cluster randomised controlled trial.

@entity1 @entity1479 @entity308 @entity24673 @entity146 @entity24962 @entity148 @entity204
BACKGROUND: @entity308 and @entity148 are common @entity146 worldwide. The MANAS trial aimed to test the effectiveness of an intervention led by lay health counsellors in primary care settings to improve outcomes of @entity1 with these disorders. METHODS: In this cluster randomised trial, primary care facilities in @entity24673 , 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 @entity146 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 @entity146 as defined by the International Statistical Classification of Diseases and Related Health Problems-10th revision ( @entity1479 -10) at 6 months. This study is registered with ClinicalTrials.gov, number NCT00446407. FINDINGS: 24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) @entity1 in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. @entity1 with @entity1479 -10-confirmed common @entity146 in the intervention group were more likely to have recovered at 6 months than were those in the control group (n=620 [65  0%] vs 553 [52  9%]; risk ratio 1  22, 95% CI 1  00-1  47; risk difference=12  1%, 95% CI 1  6%-22  5%). The intervention had strong evidence of an effect in public facility attenders (369 [65  9%] vs 267 [42  5%], risk ratio 1  55, 95% CI 1  02-2  35) but no evidence for an effect in private facility attenders (251 [64  1%] vs 286 [65  9%], risk ratio 0  95, 0  74-1  22). There were three @entity204 and four suicide attempts in the collaborative stepped-care group and six @entity204 and six suicide attempts in the enhanced usual care group. None of the @entity204 were from suicide. INTERPRETATION: A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from @entity24962 among @entity1 attending public primary care facilities. FUNDING: The Wellcome Trust.
