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Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial

Nature Medicine volume 30, pages 675–682 (2024)Cite this article

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Abstract

Anxiety experienced by women during pregnancy is highly prevalent, especially in resource-poor settings and strongly predicts postnatal common mental disorders (CMDs), anxiety and depression. We evaluated the effectiveness of an anxiety-focused early prenatal intervention on preventing postnatal CMDs. This study was a phase 3, two-arm, single-blind, randomized controlled trial conducted in Pakistan with women who were ≤22 weeks pregnant and had at least mild anxiety without clinical depression. Participants were randomized to the Happy Mother–Healthy Baby program, based on cognitive behavioral therapy, consisting of six one-on-one intervention sessions in pregnancy delivered by non-specialist providers, or to enhanced care alone. The primary outcome was major depression, generalized anxiety disorder or both at 6 weeks after delivery. Overall, 755 women completed postnatal assessments (380 (50.3%), intervention arm; 375 (49.7%) enhanced-care arm). The primary outcomes were met. Examined jointly, we found 81% reduced odds of having either a major depressive episode (MDE) or moderate-to-severe anxiety for women randomized to the intervention (adjusted odds ratio (aOR) = 0.19, 95% CI 0.14–0.28). Overall, 12% of women in the intervention group developed MDE at 6 weeks postpartum, versus 41% in the control group. We found reductions of 81% and 74% in the odds of postnatal MDE (aOR = 0.19, 95% CI 0.13–0.28) and of moderate-to-severe anxiety (aOR = 0.26, 95% CI 0.17–0.40), respectively. The Happy Mother–Healthy Baby program early prenatal intervention focusing on anxiety symptoms reduced postpartum CMDs. ClinicalTrials.gov identifier NCT03880032.

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Fig. 1: Consort diagram.
Fig. 2: Changes in CMDs, anxiety and depression, due to the HMHB program.

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Data availability

All our data and relevant codebooks have been submitted to the US NIMH Data Archive for public access, which can be accessed at https://nda.nih.gov/.

Code availability

Data structures, variables, variables names and relevant codebooks used for the statistical analyses have been uploaded to the NIMH Data Archive and are freely available to the public for use at https://nda.nih.gov/.

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Acknowledgements

We extend our heartfelt gratitude to the study participants and obstetric staff at the Department of Obstetrics and Gynaecology at Rawalpindi Medical University. Additionally, we are deeply indebted to M. Umar, R. Chaudhri and A. Tamizuddin Nizami of Rawalpindi Medical University for their unwavering support, both administrative and clinical, spanning the entire trajectory of our research from inception to completion. This study was supported by the NIMH at the US National Institutes of Health (grant no. RO1 MH111859, to P.J.S.). The NIMH had no role in the conduct of this research.

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Author notes

  1. These authors contributed equally: Pamela J. Surkan, Abid Malik.

Authors and Affiliations

  1. Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

    Pamela J. Surkan, Jamie Perin & Armaan Rowther

  2. Human Development Research Foundation, Near Government Rural Health Centre Mandra, Rawalpindi, Pakistan

    Abid Malik, Najia Atif & Ahmed Zaidi

  3. Department of Public Mental Health, Health Services Academy, Islamabad, Pakistan

    Abid Malik

  4. Department of Psychiatry, Los Angeles County Harbor-UCLA Medical Center, Los Angeles, CA, USA

    Armaan Rowther

  5. Department of Primary Care and Mental Health, Institute of Population Health, University of Liverpool, Liverpool, United Kingdom

    Atif Rahman

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Contributions

P.J.S. conceptualized the study, drafted the original manuscript, contributed to the interpretation of results and was the study’s principal investigator. A.M. supervised the implementation of the study including data collection and all field activities, reviewed the manuscript and contributed to the interpretation of the results. J.P. performed the statistical analysis, drafted the results, reviewed the manuscript and contributed to the interpretation of the results. N.A. led the development of the HMHB intervention, supervised its delivery, reviewed the manuscript and contributed to the interpretation of the results. A. Rowther contributed to the writing and editing of the manuscript. A.Z. managed the data, cleaned and curated the data and constructed the flow chart. A. Rahman conceptualized the study, assisted in supervision of the team, edited the manuscript and contributed to the interpretation of the results. All authors approved the final manuscript.

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Correspondence to Pamela J. Surkan.

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Surkan, P.J., Malik, A., Perin, J. et al. Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial. Nat Med 30, 675–682 (2024). https://doi.org/10.1038/s41591-024-02809-x

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