Delivering the Thinking Healthy Programme for Perinatal Depression Through Volunteer Peers: A Cluster Randomised Controlled Trial in Pakistan

Abstract

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 15th October 2014 and 25th February 2016, 227/283 (80%) and 226/287 (79%) women in the THPP plus EUC and EUC-alone groups, respectively, contributed primary outcome data. Overall, 90 (16%) woman had at least one serious adverse event, evenly distributed between groups. Compared to women in the EUC-alone group, those in the THPP plus EUC group had significantly lower PHQ-9 scores at 3 months (standardised mean difference, SMD=-0.30, 95% CI -0.48 to -0.11, p=<0.001) although not at 6 months (SMD=-0.13, 95% CI -0.31 to 0.06, p=0.07) and higher probability of remission at 3 months (50% vs 44%; prevalence ratio, PR=1.18 95% CI 1.06 to 1.29, p=0.002) although not at 6 months (49% vs 45%; PR=1.12, 95% CI 0.95 to 1.29, p=0.14). Repeated measures analyses over the 6 months post childbirth showed 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). There was evidence for sustained effects of the intervention, with higher prevalence of recovery (proportion not depressed at both 3 and 6 months) (35% vs 26%, p=0.002) and response I (≥50% reduction in symptoms from baseline) (53% vs 40%, p=0.003). However, no effects were observed on child outcomes. 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. Interpretation: THPP showed moderate to strong effects on symptom severity and remission at 3 months postnatal in women caring for infants and was cost-effective. Intervention benefits waned by 6 months, possibly due to spontaneous remission of participants in the EUC group, a common occurrence in depression trials. Informed Consent: Both trials will obtain informed written consent at screening and baseline, followed by re-affirmation of consent at the 3- and 6-month postnatal follow-ups. Informed written consent will be obtained by trained research teams, who will ensure it is taken appropriately. A copy of the information sheets and consent forms will be left with the participants. A record of age, depression score and reasons for refusal will be maintained for those who do not consent. Separate consent will be taken, by trained research teams, for participation in the qualitative sub-study and for the audio recording of intervention sessions to monitor therapy quality. Refusals at all stages will be documented. Trial registration: Pakistan Trial: ClinicalTrials.gov Identifier: NCT02111915 (9 April 2014) India Trial: ClinicalTrials.gov Identifier: NCT02104232 (1 April 2014) Funding: National Institute of Mental Health, USA, through 1U19MH095687 Declaration of Interests: Authors declare no competing interests. Ethics Approval Statement: Ethical approval was obtained from the Institutional Review Boards (IRBs) at the University of Liverpool, the London School of Hygiene and Tropical Medicine (LSHTM), and the Human Development Research Foundation (the trial-implementing institution in Pakistan).