TY - JOUR
KW - Adult
KW - Humans
KW - India
KW - Mental Disorders/diagnosis/therapy
KW - Mental Health
KW - Randomized Controlled Trials as Topic
KW - Rural Population
KW - Social Stigma
KW - Anti-stigma campaign
KW - Cluster randomised controlled trial
KW - common mental disorders
KW - Electronic decision support systems
KW - implementation
KW - Primary healthcare worker
KW - SMART Mental Health
AU - M. Daniel
AU - P. K. Maulik
AU - S. Kallakuri
AU - A. Kaur
AU - S. Devarapalli
AU - A. Mukherjee
AU - A. Bhattacharya
AU - L. Billot
AU - G. Thornicroft
AU - D. Praveen
AU - U. Raman
AU - R. Sagar
AU - S. Kant
AU - B. Essue
AU - S. Chatterjee
AU - S. Saxena
AU - A. Patel
AU - D. Peiris
A1 - 
AB - BACKGROUND: Around 1 in 7 people in India are impacted by mental illness. The treatment gap for people with mental disorders is as high as 75-95%. Health care systems, especially in rural regions in India, face substantial challenges to address these gaps in care, and innovative strategies are needed. METHODS: We hypothesise that an intervention involving an anti-stigma campaign and a mobile-technology-based electronic decision support system will result in reduced stigma and improved mental health for adults at high risk of common mental disorders. It will be implemented as a parallel-group cluster randomised, controlled trial in 44 primary health centre clusters servicing 133 villages in rural Andhra Pradesh and Haryana. Adults aged ≥ 18 years will be screened for depression, anxiety and suicide based on Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorders (GAD-7) scores. Two evaluation cohorts will be derived-a high-risk cohort with elevated PHQ-9, GAD-7 or suicide risk and a non-high-risk cohort comprising an equal number of people not at elevated risk based on these scores. Outcome analyses will be conducted blinded to intervention allocation. EXPECTED OUTCOMES: The primary study outcome is the difference in mean behaviour scores at 12 months in the combined 'high-risk' and 'non-high-risk' cohort and the mean difference in PHQ-9 scores at 12 months in the 'high-risk' cohort. Secondary outcomes include depression and anxiety remission rates in the high-risk cohort at 6 and 12 months, the proportion of high-risk individuals who have visited a doctor at least once in the previous 12 months, and change from baseline in mean stigma, mental health knowledge and attitude scores in the combined non-high-risk and high-risk cohort. Trial outcomes will be accompanied by detailed economic and process evaluations. SIGNIFICANCE: The findings are likely to inform policy on a low-cost scalable solution to destigmatise common mental disorders and reduce the treatment gap for under-served populations in low-and middle-income country settings. TRIAL REGISTRATION: Clinical Trial Registry India CTRI/2018/08/015355 . Registered on 16 August 2018.
AD - The George Institute for Global Health, New Delhi, India.; The George Institute for Global Health, New Delhi, India. pmaulik@georgeinstitute.org.in.; University of New South Wales, Sydney, Australia. pmaulik@georgeinstitute.org.in.; Prasanna School of Public Health, Manipal, India. pmaulik@georgeinstitute.org.in.; The George Institute for Global Health, Oxford, UK. pmaulik@georgeinstitute.org.in.; The George Institute for Global Health, Hyderabad, India.; The George Institute for Global Health, New Delhi, India.; The George Institute for Global Health, Hyderabad, India.; The George Institute for Global Health, New Delhi, India.; The George Institute for Global Health, New Delhi, India.; The George Institute for Global Health, University of New South Wales, Sydney, Australia.; Centre for Global Mental Health and Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.; University of New South Wales, Sydney, Australia.; Prasanna School of Public Health, Manipal, India.; The George Institute for Global Health, Hyderabad, India.; University of Hyderabad, Hyderabad, India.; All India Institute of Medical Sciences, New Delhi, India.; All India Institute of Medical Sciences, New Delhi, India.; Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.; The George Institute for Global Health, New Delhi, India.; University of New South Wales, Sydney, Australia.; Prasanna School of Public Health, Manipal, India.; Harvard T H Chan School of Public Health, Boston, USA.; The George Institute for Global Health, University of New South Wales, Sydney, Australia.; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
BT - Trials
C5 - Healthcare Disparities; Measures
CP - 1
DO - 10.1186/s13063-021-05136-5
IS - 1
JF - Trials
LA - eng
M1 - Journal Article
N2 - BACKGROUND: Around 1 in 7 people in India are impacted by mental illness. The treatment gap for people with mental disorders is as high as 75-95%. Health care systems, especially in rural regions in India, face substantial challenges to address these gaps in care, and innovative strategies are needed. METHODS: We hypothesise that an intervention involving an anti-stigma campaign and a mobile-technology-based electronic decision support system will result in reduced stigma and improved mental health for adults at high risk of common mental disorders. It will be implemented as a parallel-group cluster randomised, controlled trial in 44 primary health centre clusters servicing 133 villages in rural Andhra Pradesh and Haryana. Adults aged ≥ 18 years will be screened for depression, anxiety and suicide based on Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorders (GAD-7) scores. Two evaluation cohorts will be derived-a high-risk cohort with elevated PHQ-9, GAD-7 or suicide risk and a non-high-risk cohort comprising an equal number of people not at elevated risk based on these scores. Outcome analyses will be conducted blinded to intervention allocation. EXPECTED OUTCOMES: The primary study outcome is the difference in mean behaviour scores at 12 months in the combined 'high-risk' and 'non-high-risk' cohort and the mean difference in PHQ-9 scores at 12 months in the 'high-risk' cohort. Secondary outcomes include depression and anxiety remission rates in the high-risk cohort at 6 and 12 months, the proportion of high-risk individuals who have visited a doctor at least once in the previous 12 months, and change from baseline in mean stigma, mental health knowledge and attitude scores in the combined non-high-risk and high-risk cohort. Trial outcomes will be accompanied by detailed economic and process evaluations. SIGNIFICANCE: The findings are likely to inform policy on a low-cost scalable solution to destigmatise common mental disorders and reduce the treatment gap for under-served populations in low-and middle-income country settings. TRIAL REGISTRATION: Clinical Trial Registry India CTRI/2018/08/015355 . Registered on 16 August 2018.
PY - 2021
SN - 1745-6215; 1745-6215
SP - 179
T1 - An integrated community and primary healthcare worker intervention to reduce stigma and improve management of common mental disorders in rural India: Protocol for the SMART Mental Health programme
T2 - Trials
TI - An integrated community and primary healthcare worker intervention to reduce stigma and improve management of common mental disorders in rural India: Protocol for the SMART Mental Health programme
U1 - Healthcare Disparities; Measures
U2 - 33653406
U3 - 10.1186/s13063-021-05136-5
VL - 22
VO - 1745-6215; 1745-6215
Y1 - 2021
Y2 - Mar 2
ER -