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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- Finding
The trial population was predominantly female and had a mean age of 46.3 years.
“The trial population was predominantly female (82%), with mean age 46.3 years (SD 13.3 years).”
Quote in the paperNot yet classified - Finding
The trial is described as the largest effectiveness trial of a primary-care based intervention to integrate CMD treatments into routine primary care in a developing country.
“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.”
Quote in the paperNot yet classified - Finding
The intervention had a generally strong and consistent effect in PHC attenders but not in GP attenders for most diagnostic groups apart from depression.
“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.”
Quote in the paperNot yet classified - Finding
The intervention was delivered with high fidelity to the original protocol except for IPT.
“These process indicators show that, apart from the IPT, the intervention was delivered with high fidelity to the original protocol.”
Quote in the paperNot yet classified - Finding
There was modest evidence that the intervention improved six-month recovery from ICD-10 cases overall, with a larger effect in PHCs than in GP facilities.
“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).”
Quote in the paperNot yet classified
- Finding
Among screen-positive cases, the intervention halved the prevalence of ICD-10 in PHCs at six months, with no effect in GP facilities.
“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).”
Quote in the paperNot yet classified - Finding
For each diagnostic group, mean CIS-R symptom scores were lower in the CSC arm than in the EUC arm.
“For each diagnostic group, the mean CIS-R score was lower in the CSC than the EUC arm.”
Quote in the paperNot yet classified - Finding
Of 20,352 screened patients, 3,816 screened positive for CMD and 2,796 consented and were enrolled.
“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”
Quote in the paperNot yet classified - Finding
At six months, patients with ICD-10 definite CMD in the intervention arm were more likely to have recovered than those in the control arm.
“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%).”
Quote in the paperNot yet classified - Finding
The trial demonstrates that an intervention led by a trained lay counsellor improves recovery from common mental disorders, particularly among people attending primary health care facilities.
“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.”
Quote in the paperNot yet classified - Method
The trial's primary analysis compared the proportion of ICD-10 cases at baseline who recovered at six months.
“the primary analysis was the difference across arms in the proportion of ICD-10 cases at baseline who recover at six months.”
Quote in the paperNot yet classified0 of 1 sources checked- cites [37]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Method
The lay health counsellor acted as case manager for everyone who screened positive for CMD and was responsible for delivering all non-drug treatments.
“The LHC acted as a case-manager for all who screened positive for CMD and took overall responsibility for delivering the intervention for all non-drug treatments, in close collaboration with the primary care physician and the clinical specialist.”
Quote in the paperNot yet classified - Method
The objective was to evaluate the effectiveness of a lay health counsellor led collaborative stepped care intervention on recovery from common mental disorders in public and private primary care settings.
“To evaluate the effectiveness of a LHC led collaborative stepped care (CSC) intervention on recovery from CMD in public (government) Primary Health Centre (PHC) and private General Practitioner (GP) health care settings”
Quote in the paperNot yet classified - Method
Twenty-four primary care facilities were randomly allocated to collaborative stepped care or enhanced usual care.
“Twenty-four primary care facilities, with an equal proportion of public Primary Health Centres (PHC) and private General Practitioners (GP) practices, were randomly allocated within pre-defined strata, to intervention (collaborative stepped care, CSC) or control (enhanced usual care, EUC) groups.”
Quote in the paperNot yet classified - Method
The CSC intervention combined case management and psychosocial interventions by a trained Lay Health Counsellor, antidepressant medication by the primary care physician, and supervision by a visiting mental health specialist.
“The CSC arm provided case management and psychosocial interventions, delivered by a trained Lay Health Counsellor, antidepressant medication by the primary care physician and supervision by a visiting mental health specialist.”
Quote in the paperNot yet classified - Method
The study used a cluster randomized trial design with primary care facility as the unit of randomisation.
“Cluster randomised trial with primary care facility as unit of randomisation.”
Quote in the paperNot yet classified - Method
The locally recruited lay health counsellor had no health background and completed a structured two month training course.
“The locally-recruited LHC had non-health backgrounds and underwent a structured two month training course”
Quote in the paperNot yet classified - Method
The trial was conducted in Goa, India, through collaboration between Sangath, LSHTM, the Government of Goa's health services, the Voluntary Health Association of Goa, and private general practitioners.
“Manas was implemented by Sangath, a Goan community mental health non-governmental organization, in collaboration with the London School of Hygiene & Tropical Medicine (LSHTM), the Government of Goa’s Directorate of Health Services, the Voluntary Health Association of Goa and private general practitioners.”
Quote in the paperNot yet classified - Background
The MANAS trial was implemented to test whether a lay health worker led intervention improves outcomes for people with common mental disorders in primary health care settings in Goa, India.
“The MANAS trial was implemented to test the effectiveness of a lay health worker led intervention in primary health care settings to improve outcomes of people with CMD in Goa, India.”
Quote in the paperNot yet classified - Method
The trial was run in two consecutive phases from April 2007 to September 2009, with 12 PHCs in phase 1 and 12 GP facilities in phase 2.
“The trial was conducted in two consecutive phases from April 2007 to September 2009. Phase 1 involved 12 PHCs, while Phase 2 was conducted in 12 GP facilities.”
Quote in the paperNot yet classified - Background
Most people with common mental disorders seek care in primary care settings, where recognition is poor.
“The majority of persons with CMD seek healthcare in primary care settings[1] where recognition is poor, with fewer than one third of clinically significant cases detected[11].”
Quote in the paperNot yet classified0 of 2 sources checked - Method
Adults attending a facility were screened for common mental disorders with the General Health Questionnaire, and those scoring above five were eligible for participation.
“All adults presenting at a facility were screened for CMD with the General Health Questionnaire and those scoring above a cut-off point of five were regarded as eligible for participation in the trial.”
Quote in the paperNot yet classified - Background
Depressive and anxiety disorders are the leading neuropsychiatric cause of the global burden of disease.
“Depressive and anxiety disorders are the leading neuropsychiatric cause of the global burden of disease[1],”
Quote in the paperNot yet classified0 of 1 sources checked- cites [1] Patel, 2003, Poverty and common mental disorders in developing countries, Bull World Health Organ source
Not checked in the free run.
- Method
The primary outcome was recovery from ICD-10 defined common mental disorder six months after recruitment.
“The primary outcome was recovery from ICD-10 defined CMD six months after recruitment.”
Quote in the paperNot yet classified - Background
The intervention was based on a stepped-care approach that reserved more resource-intensive interventions for patients who were severely ill or not responding to simpler interventions.
“the intervention is based on the stepped-care approach used in a Chilean trial [17] which emphasizes that while simple interventions such as psycho-education may be provided to all patients, more resource-intensive interventions may be reserved for participants who are severely ill or not responding to the simpler interventions.”
Quote in the paperNot yet classified0 of 1 sources checked- cites [17] Lewin, 2005, Lay health workers in primary and community health care, Cochrane Database Syst Rev source
Not checked in the free run.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
A collaborative care program involving lay health workers in primary and private care settings reduced suicide rates, and depression screening studies with psychiatrist-overseen antidepressant treatment reduced suicide rates in both men and women.
“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]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredTraining nonmental health professionals to deliver mental health care in a collaborative, stepped-care, task-sharing approach is an effective approach to mitigating the shortage of mental health specialists.
“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 <i>HAPPINESS</i> intervention (2024) · cites this paper as Patel et al., 2010
The Background describes task shifting as a way to address specialist shortages, and The Interventions describes trained lay counsellors delivering care within a collaborative, stepped-care team. The Results and Discussion report improved recovery chiefly in public primary health centres, with no effect in private GP facilities or among patients with depression. The claim overgeneralizes the intervention's effectiveness, and the trial did not directly measure a reduction in the specialist shortage. (LLM, conf=0.87)
Experimental — accuracy not yet measuredThere have been stepped care initiatives in LMICs, but these have been limited to providing different levels of non-specialist counselling, psychotherapy and antidepressant medication, depending on the person's mental health needs.
“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]
The Background and Design and Methods (The Interventions; page unavailable) describe stepped care in Goa, with lay-counsellor psychoeducation, psychotherapy and antidepressants allocated according to severity or response. But the claim’s “limited to” wording omits psychiatric consultation: the intervention also referred some patients to a visiting clinical specialist, including those at high suicide risk or unresponsive to earlier treatment. (LLM, conf=0.88)
Experimental — accuracy not yet measuredPrevious studies where nurses and other lay community health workers delivered psychosocial interventions effectively support these results.
“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]
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.
“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]).”
The Latin American task-shifted treatment model was subsequently successfully adapted and replicated in other low-middle income countries.
“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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Chronic diseases and injuries in India
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Improving access to psychological treatments: lessons from developing countries
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Addressing critical gaps in the treatment of eating disorders
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“Models of task-sharing mental health interventions are varied, such as utilizing primary care providers to detect or provide care for mental health concerns within a broader healthcare system [6–8]; training and supervising community/lay health workers to administer psychotherapy for common mental disorders [6, 9]; an…”
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Global Mental Health: From Science to Action
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Economic evaluation of a task-shifting intervention for common mental disorders in India
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Self-citationDepression and associated factors in older adults in South Africa
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“Was an adequate sensitivity analysis performed? global mental health included although two of these reported on the same randomized controlled trial on MANAS in India (Patel et al. 2010b, 2011), and three were based on different perspectives of the community mental health programme in Ghana (Agyapong et al. 2015a, b,…”
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MEASURING DEPRESSION AND ANXIETY IN SUB-SAHARAN AFRICA
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Self-citationArt therapy as an adjuvant treatment for depression in elderly women: a randomized controlled trial
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- 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
- Social Sciences › Psychology › Social Psychology › 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
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