Delivering the Thinking Healthy Programme for perinatal depression through volunteer peers: a cluster randomised controlled trial in Pakistan (original) (raw)

Background: The Thinking Healthy Programme (THP), endorsed by WHO, is an evidence-based intervention for perinatal depression. We adapted THP for delivery by volunteer peers (THPP)-lay women from the community-and assessed its effectiveness and cost-effectiveness in Rawalpindi, Pakistan. Methods: In this cluster randomised controlled trial, 40 village-clusters were equally randomised to intervention (THPP plus Enhanced Usual Care (EUC)) or to EUC-alone. Consenting pregnant women aged ≥18 years who scored >10 on the nine-item Patient Health Questionnaire (PHQ-9) were eligible. Follow-up visits were at 3 and 6 months post childbirth. Primary outcomes were depressive symptoms score and remission at 6 months post-childbirth. Secondary outcomes included recovery from depression, levels of disability and perceived social support and child outcomes. All assessors were masked, and analyses were modified intention-to-treat. The trial was registered with ClinicalTrials.gov (NCT02111915). Findings: Of the 570 women enrolled between 15 th October 2014 and 25 th February 2016, 227/283 (80%) and 226/287 (79%) women in the THPP plus EUC and EUC-alone groups, respectively, contributed primary outcome data. Compared to women in the EUC-alone group, those in the THPP plus EUC group at 6 months had lower PHQ-9 scores and better proportions of remission, but neither reached statistical significance (standardised mean difference, SMD=-0•13, 95% CI-0•31 to 0•06, p=0•07; 49% vs 45%; Prevalence Ratio PR=1•12, 95% CI 0•95 to 1•29, p=0.14 respectively). Repeated measures analyses over the 6 months post childbirth showed beneficial intervention effects on both PHQ-9 scores (SMD=-0•22, 95%CI-0•35 to-0•09, p=<0•001) and remission (PR=1•15 95% CI 1•02 to 1•28, p=0•02), disability scores (SMD=-0•12, 95% CI-0•25 to 0•01, p=0•03) and perceived social support scores (SMD=0•16, 95%CI 0•03 to 0•29, p=0•01). THPP was associated with slightly higher costs than EUC-alone but significantly better outcome, thereby rendering it a cost-effective intervention; total societal cost per unit improvement on PHQ-9 was US$ 2•65 (95% CI 1•82 to 3•49) at 3 months post childbirth, US$ 1•17 (95% CI-0•53 to 2•88) for the 3-6-month post-childbirth period and US$ 15•50 (95% CI 9•59 to 21•61) over the study period as a whole. There was no evidence of differences in serious adverse events by group. Interpretation: THPP showed moderate effects on symptom severity and remission from perinatal depression over the 6-month postnatal period among women caring for infants and was also costeffective. Our intervention delivered by lay peers can be a potential step towards using an untapped human resource to address the treatment gap of perinatal depression.