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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
Open accessAbstract
Background Depression and anxiety disorders are common mental disorders 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 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.Findings 24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) patients in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. Patients with ICD-10-confirmed common mental disorders 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 deaths and four suicide attempts in the collaborative stepped-care group and six deaths and six suicide attempts in the enhanced usual care group. None of the deaths were from suicide.Interpretation A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from CMD among patients attending public primary care facilities.Funding The Wellcome Trust.
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“The trial population was predominantly female (82%), with mean age 46.3 years (SD 13.3 years).”
§ The effectiveness of a lay health worker led intervention for depressive and anxiety disorders in primary care: the MANAS cluster randomized trial in Goa, India > Results > Study population
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“The MANAS trial is the largest effectiveness trial of a primary-care based intervention to integrate CMD treatments into routine primary care in a developing country.”
§ The effectiveness of a lay health worker led intervention for depressive and anxiety disorders in primary care: the MANAS cluster randomized trial in Goa, India > Abstract > Implications
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“Secondary analyses showed that the intervention had a generally strong and consistent effect in PHC facility attenders but not GP facility attenders for all diagnostic groups apart from depression where no effect was found.”
§ The effectiveness of a lay health worker led intervention for depressive and anxiety disorders in primary care: the MANAS cluster randomized trial in Goa, India > Abstract > Results
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“These process indicators show that, apart from the IPT, the intervention was delivered with high fidelity to the original protocol.”
§ The effectiveness of a lay health worker led intervention for depressive and anxiety disorders in primary care: the MANAS cluster randomized trial in Goa, India > Results > Process indicators (Table 6)
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“There was modest evidence of an effect of the intervention on recovery from ICD-10 cases at six months (proportion recovered: 65.0% vs. 52.9% in CSC and EUC arms respectively; RR=1.22, 95%CI 1.00,1.47). The effect was larger among PHC participants (65.9% vs. 42.5%, RR=1.55, 95%CI 1.02,2.35) but not GP participants (64.1% vs. 65.9%, RR=0.95, 95%CI 0.74, 1.22, p-value for effect-modification=0.001).”
§ The effectiveness of a lay health worker led intervention for depressive and anxiety disorders in primary care: the MANAS cluster randomized trial in Goa, India > Results > Impact of the intervention
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“There was modest evidence of an effect on prevalence of ICD-10 at six months among screen positive cases, with a halving of prevalence in PHCs (RR=0.54, 95%CI 0.34, 0.81) but no effect in GP facilities (p-value for effect-modification=0.003).”
§ The effectiveness of a lay health worker led intervention for depressive and anxiety disorders in primary care: the MANAS cluster randomized trial in Goa, India > Results > Impact of the intervention
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“For each diagnostic group, the mean CIS-R score was lower in the CSC than the EUC arm.”
§ The effectiveness of a lay health worker led intervention for depressive and anxiety disorders in primary care: the MANAS cluster randomized trial in Goa, India > Results > Impact of the intervention
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“Altogether 20,352 patients were screened, of whom 3,816 (18.8%) screened positive for CMD and 3,434 were eligible to participate. Of these, 2,796 (81%) consented to participate and were enrolled”
§ The effectiveness of a lay health worker led intervention for depressive and anxiety disorders in primary care: the MANAS cluster randomized trial in Goa, India > Results > Participant flow
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“Patients with ICD-10 definite CMD in the intervention arm were more likely to have recovered at 6 months (65% vs 53%; risk ratio=1.22, 95%CI 1.00–1.47; risk difference=12%, 95%CI 2%-23%).”
§ The effectiveness of a lay health worker led intervention for depressive and anxiety disorders in primary care: the MANAS cluster randomized trial in Goa, India > Abstract > Results
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“The trial demonstrates that an intervention led by a trained lay counsellor improves recovery from CMD, in particular among those attending primary health care facilities.”
§ The effectiveness of a lay health worker led intervention for depressive and anxiety disorders in primary care: the MANAS cluster randomized trial in Goa, India > Abstract > Implications
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“The exceptions are a collaborative care program involving lay health workers in both primary and private care settings(116), and depression screening studies in which psychiatrists oversaw the antidepressant treatment resulting in reduced suicide rates in both men and women (Table 2).”
From Improving Suicide Prevention Through Evidence-Based Strategies: A Systematic Review (2021) · cites this paper as [116]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“an effective approach to mitigating the shortage is training nonmental health professionals to deliver packages of mental health care in a collaborative, stepped-care, task-sharing approach (Patel et al., 2010; Padmanathan and De Silva, 2013; Raviola et al., 2019).”
From Integrating mental health into primary care in Nigeria: Implementation outcomes and clinical impact of the HAPPINESS intervention (2024) · cites this paper as Patel et al., 2010
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“There have been stepped care initiatives in LMICs; however, these have been limited to providing different levels of non-specialist counselling, psychotherapy and antidepressant medication, depending on the person’s mental health needs.22”
From Evaluating a stepped care model of psychological support for adults affected by adversity: study protocol for a randomised controlled trial in Jordan (2024) · cites this paper as [22]
Experimental — accuracy not yet measuredIn the citing paper
“These results are also supported by previous studies where nurses and other lay community health workers delivered psychosocial interventions effectively.10,43”
From Process evaluation of a district mental healthcare plan in Nepal: a mixed-methods case study (2020) · cites this paper as [43]
In the citing paper
“The sample size was calculated on the prediction of a small to moderate effect size (d = 0.4) on the GHQ-12 at the 3-month follow-up assessment (based on prior interventions in primary care [40]).”
In the citing paper
“it was subsequently successfully adapted and replicated in other LMICs (9, 10).”
From Internet-Based Interventions for the Prevention and Treatment of Mental Disorders in Latin America: A Scoping Review (2019) · cites this paper as [9]
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Metadata
- Authors
- Patel, V., Weiss, H. A., Chowdhary, N., Naik, S., Pednekar, S., Chatterjee, S., De Silva, M. J., Bhat, B., Araya, R., King, M., Simon, G., Verdeli, H., & Kirkwood, B. R.
- Affiliations
- London School of Hygiene & Tropical Medicine (GB)
- Sangath (IN)
- Voluntary Health Association of Goa (IN)
- University of Bristol (GB)
- The Royal Free Hospital (GB)
- Group Health Cooperative (US)
- Columbia University (US)
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2010-12
- Volume
- 376
- Issue
- 9758
- Pages
- 2086-2095
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC4964905
- OpenAlex
- W2100008637
- Cited by
- 752
- References
- 44
- Citations by year
- 2026: 39 · 2025: 39 · 2024: 41 · 2023: 54 · 2022: 56 · 2021: 80 · 2020: 44 · 2019: 60 · 2018: 34 · 2017: 63 · 2016: 45 · 2015: 51 · 2014: 52 · 2013: 37 · 2012: 44
- FWCI
- 40.91
- Type
- journal article
- Language
- en
- Open access
- green
- orcid.org
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Research Portal (King's College London) (submittedVersion, other-oa)
- Bristol Research (University of Bristol) (submittedVersion)
- Funders
- Wellcome Trust (091834, 076783)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Mental Health Treatment and Access
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Social Sciences › Psychology › Clinical Psychology › Psychiatric care and mental health services
- Keywords
- common mental disorders, depression, anxiety disorders, stepped-care intervention, primary care, case management, psychosocial interventions, antidepressants, public vs private health facilities, suicide attempts, community mental health services, Goa
- MeSH terms
- Workforce, Adolescent, Adult, Aged, Allied Health Personnel, Antidepressive Agents, Anxiety Disorders, Cooperative Behavior, Counseling, Depressive Disorder, Female, Fluoxetine, Humans, India, Male, Middle Aged, Patient Education as Topic, Primary Health Care, Psychotherapy, Severity of Illness Index, Suicide, Attempted, Odds Ratio, Treatment Outcome, Outcome Assessment, Health Care, Public Sector, Directive Counseling, Young Adult, General Practice
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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