Cited by 752Mental Health Treatment and AccessHealth Policy Implementation SciencePsychiatric care and mental health services

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

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Patel, Vikram, Weiss, Helen A, Chowdhary, Neerja, Naik, Smita, Pednekar, Sulochana, Chatterjee, Sudipto, De Silva, Mary J, Bhat, Bhargav +5 more·2010·The Lancet

Abstract

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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Crossref · 10.1016/s0140-6736(10)61508-5

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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

Claims other papers make about this one

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  • 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 measured
  • Training 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 measured
  • There 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 measured
  • Previous 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”
  • 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]).”

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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)
Venue
The Lancet
Publisher
Elsevier BV
Published
2010-12
Volume
376
Issue
9758
Pages
2086-2095
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
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
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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