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Now published in The Lancet

Delivering the Thinking Healthy Programme for Perinatal Depression Through Peers: An Individually- Randomised Controlled Trial in India

61 Pages Posted: 12 Sep 2018

See all articles by Daniela C. Fuhr

Daniela C. Fuhr

London School of Hygiene & Tropical Medicine - Department of Health Services Research and Policy

Benedict Weobong

London School of Hygiene & Tropical Medicine; Sangath Centre

Anisha Lazarus

Sangath Centre

Fiona Vanobberghen

London School of Hygiene & Tropical Medicine - MRC Tropical Epidemiology Group (TEG)

Helen A. Weiss

London School of Hygiene & Tropical Medicine - MRC Tropical Epidemiology Group (TEG)

Daisy R. Singla

Sinai Health Network

Hanani Tabana

University of the Western Cape - Faculty of Community and Health

Ejma Afonso

Sangath Centre

Aveena De Sa

Sangath Centre

Ethel D'Souza

Sangath Centre

Akankasha Joshi

Sangath Centre

Pryia Korgaonkar

Sangath Centre

Revathi Krishna

Sangath Centre

LeShawndra N. Price

Government of the United States of America - National Institute of Mental Health; Government of the United States of America - National Heart, Lung and Blood Institute

Atif Rahman

University of Liverpool - Institute of Psychology, Health and Society

Vikram Patel

Harvard University - Business School (HBS)

More...

Abstract

Background: The Thinking Healthy Programme (THP) is a psychological intervention recommended for the treatment of perinatal depression. We assessed the effectiveness and cost-effectiveness of THP delivered by peers (THPP) in Goa, India.

Methods: In this single-blind, individually-randomised controlled trial, we recruited pregnant women aged =18 years attending antenatal clinics, who scored =10 on the Patient Health Questionnaire (PHQ-9). Participants were randomly allocated (1:1) to THPP plus enhanced usual care (EUC), or to EUC alone in randomly-sized blocks, stratified by area of residence. Allocation was concealed using sequentially-numbered opaque envelopes. Primary outcomes were severity of depressive symptoms (PHQ-9 score) and remission (PHQ-9 score <5) 6 months post-birth assessed by researchers masked to the treatment allocation. Analyses were by intention to treat, adjusting for covariates defined a priori or that showed imbalance at baseline.

Findings: 280 women were enrolled between 24th October 2014 and 22nd June 2016 (140 per group). At 6 months, 122 (87%) and 129 (92%) women in the THPP plus EUC, and EUC alone groups, respectively, contributed primary outcome data. There was evidence of higher prevalence of remission at 6 months in the THPP plus EUC versus EUC alone group (n=89 (73%) versus n=77 (60%), respectively; prevalence ratio (PR)=1·21; 95% confidence interval (CI) 1·01 to 1·45, p=0·04), but weaker evidence for lower symptom severity (mean 3·5, standard deviation (SD) 4·5 versus 4·5 (SD=5·1), respectively; standardised mean difference (SMD)=-0·18; 95% CI -0·43 to 0·07, p=0·16). Repeated measures analyses over the duration of the trial (measured at 3 and 6 months post-birth) showed beneficial effects on symptom severity (SMD -0·37, 95% CI -0·88 to -0·24, p=0·01), remission (PR=1·21, 95% CI 1·01 to 1·41, p=0·02), WHO-Disability Assessment Schedule (WHO-DAS) scores (SMD=-0·32, 95% CI -0·76 to -0·21, p=0·02) and Multidimensional Scale of Perceived Social Support (MSPSS) scores (SMD=0·51, 95% CI 0·43 to 1·20, p=0·02). However, no effects were observed on child outcomes at 6 months. The incremental societal cost per unit improvement on PHQ-9 was -US$-29·64 (95% CI-32·88 to -26·41) at 3 months, and -US$93·53 (95% CI -180·21 to -6·84) for the whole duration of the trial, with a 87% likelihood of being cost-saving in the study setting. There was no evidence of differences in serious adverse events by group, except stigmatisation was more often reported in the EUC alone (9%) versus the THPP plus EUC group (4%; p=0·08).

Interpretation: THPP had a moderate effect on symptom severity and remission from perinatal depression over the 6 month post-natal period. THPP is relatively cheap to deliver and pays for itself through reduced health care, time and productivity costs.

Clinical Trial Number: The trial is registered with ClinicalTrials.gov (NCT02104232).

Funding Statement: NIMH (National Institute of Mental Health)

Declaration of Interests: Authors declare no competing interests.

Ethics Approval Statement: The trial protocols have been granted ethical approval from the respective sites, the Institutional Review Board of Human Development Research Foundation (Pakistan), Institutional Review Board of Sangath (Goa, India), Indian Council of Medical Research, Observational/Interventions Research Ethics Committee of LSHTM, UK, and the Committee of Research Ethics at University of Liverpool, UK. Lastly, both trial protocols have ethical approval granted by the Global Mental Health DSMB of NIMH, USA.

Keywords: Perinatal Depression, Low-Intensity Psychological Treatment, Task-Sharing, India

Suggested Citation

Fuhr, Daniela C. and Weobong, Benedict and Lazarus, Anisha and Vanobberghen, Fiona and Weiss, Helen A. and Singla, Daisy R. and Tabana, Hanani and Afonso, Ejma and De Sa, Aveena and D'Souza, Ethel and Joshi, Akankasha and Korgaonkar, Pryia and Krishna, Revathi and Price, LeShawndra N. and Rahman, Atif and Patel, Vikram, Delivering the Thinking Healthy Programme for Perinatal Depression Through Peers: An Individually- Randomised Controlled Trial in India (July 16, 2018). Available at SSRN: https://ssrn.com/abstract=3223943 or http://dx.doi.org/10.2139/ssrn.3223943

Daniela C. Fuhr

London School of Hygiene & Tropical Medicine - Department of Health Services Research and Policy

London
United Kingdom

Benedict Weobong

London School of Hygiene & Tropical Medicine

Keppel Street
London, WC1E 7HT
United Kingdom

Sangath Centre

India

Anisha Lazarus

Sangath Centre

India

Fiona Vanobberghen

London School of Hygiene & Tropical Medicine - MRC Tropical Epidemiology Group (TEG)

London
United Kingdom

Helen A. Weiss

London School of Hygiene & Tropical Medicine - MRC Tropical Epidemiology Group (TEG)

London
United Kingdom

Daisy R. Singla

Sinai Health Network ( email )

Toronto
Canada

Hanani Tabana

University of the Western Cape - Faculty of Community and Health

Cape Town
South Africa

Ejma Afonso

Sangath Centre

India

Aveena De Sa

Sangath Centre

India

Ethel D'Souza

Sangath Centre

India

Akankasha Joshi

Sangath Centre

India

Pryia Korgaonkar

Sangath Centre

India

Revathi Krishna

Sangath Centre

India

LeShawndra N. Price

Government of the United States of America - National Institute of Mental Health

6001 Executive Boulevard, Rm. 7117, MSC 9629
Bethesda, MA 20892
United States

Government of the United States of America - National Heart, Lung and Blood Institute

73 Mr. Wayte Avenue
Bethesda, MD 01702
United States

Atif Rahman

University of Liverpool - Institute of Psychology, Health and Society ( email )

Liverpool
United Kingdom

Vikram Patel (Contact Author)

Harvard University - Business School (HBS) ( email )

Soldiers Field Road
Morgan 270C
Boston, MA 02163
United States