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 sequentiallynumbered 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. The trial is registered with ClinicalTrials.gov (NCT02104232).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 3·47, standard deviation (SD) 4·49 versus 4·48 (SD=5·11), 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). . 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$93·53 (95% CI -180·21 to -6·84) for the whole duration of the trial, with a 87% likelihood of being costsaving in the study setting. The mean cost of providing THPP was US$ 1·36 per beneficiary (95% CI 1·32 to 1·39). 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.
Funding: NIMH
