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Delivering the Thinking Healthy Programme for Perinatal Depression Through Peers: An Individually- Randomised Controlled Trial in India
61 Pages Posted: 12 Sep 2018
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: Suggested Citation