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Treating comorbid post-traumatic stress and depression in perinatal populations: findings from a pragmatic randomized controlled trial

Nature Mental Health (2025)Cite this article

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Abstract

Post-traumatic stress (PTS) is highly comorbid with depression but understudied among perinatal populations. Here, using Scaling Up Maternal Mental healthcare by Increasing access to Treatment Trial (NCT04153864) data on trauma, we examined (1) the prevalence and correlates of baseline PTS symptoms among perinatal patients with comorbid depressive symptoms, (2) the potential impact of an eight-session behavioral activation (BA) on PTS symptoms at 3 months post-randomization and (3) the potential moderators of PTS symptoms. We included 1,102 participants who received ≥1 BA session and completed the six-item Post-Traumatic Stress Disorder Checklist Checklist (PCL-6). At baseline, 69.78% of the patients met the clinical thresholds for PTS symptom criteria (PCL-6 ≥14) and relevant correlates included socioeconomic (lower income and education, and higher unemployment) and clinical (greater psychotropic medication use and symptoms of depressive and anxiety) variables. The PTS scores decreased significantly from baseline to 3 months (PCL-6 decreased from 18.17 to 14.68, P < 0.0001) and were moderated by baseline PTS severity, and not by baseline depressive symptoms, race/ethnicity or perinatal period. Thus, BA may be an effective treatment option for comorbid PTS symptoms, regardless of sociodemographic characteristics.

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Fig. 1: Comparing PTS (PCL-6) symptom scores between baseline and 3-months post-randomization.
Fig. 2: Moderator analysis showing change in PTS symptom scores moderated by PTS baseline severity, race and ethnicity, and perinatal period (N = 1,050).

Data availability

The data that support the findings of this study were not publicly available at the time of publication owing to the study’s long-term data collection. At 2 years after publication, all individual participant de-identified data will be shared with researchers who submit a written proposal to summittrial@sinaihealth.ca. The data will be available indefinitely. This timeline allows the study team to collect long-term study outcomes and analyze and potentially publish the results of the aims involving sustained outcomes at 12 months post-randomization as indicated in our detailed Statistical Analysis Plan. Researchers requesting data will receive a response from the study team within three business days.

Code availability

At 2 years after publication, the analytic code will be shared with researchers who submit a formal written proposal to summittrial@sinaihealth.ca. The code will be available indefinitely. This timeline allows the study team to analyze and potentially publish the results of the secondary aims involving sustained outcomes at 12 months post-randomization as indicated in our detailed Statistical Analysis Plan. Researchers requesting the code will receive a response from the study team within 3 business days.

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Acknowledgments

The SUMMIT trial was supported by a Patient-Centered Outcomes Research Institute (PCORI) Pragmatic Clinical Study Award (award no. PCS-2018C1-10621) awarded to D.R.S. We thank the patients and treatment providers who participated in this trial, members of the independent data and safety management board (S. Goodman (chair), R. Gibbons, C.E. Monk and T. Oberlander), our dedicated stakeholders (A. Beck, J. Burkhard, J. Charlebois, W. Davis, S. Dimidjian, A. Griffen, B. Gunyon-Meyer, R. Lamba, W. Lopez, S. Lye, R. Maunder, F. Meffe, M. Sabini, M. Sermer, S. Sockalingham, P. Tomasi, K. Tully, L. Wiesenfeld and C. Zlobin), and all research staff involved in the trial. PCORI had no role in the writing of this paper or the decision to submit it for publication. No author on this paper was paid to write this paper by a pharmaceutical company or other for-profit agency.

Author information

Author notes

  1. These authors contributed equally: Richard K. Silver, Simone N. Vigod.

  2. These authors jointly supervised this work: Samantha Meltzer-Brody, Vikram Patel.

Authors and Affiliations

  1. Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada

    Daisy R. Singla, Siying Li, Sandeep Shelly & Andrea S. Lawson

  2. Lunenfeld-Tanenbaum Research Institute, Sinai Health, Toronto, Ontario, Canada

    Daisy R. Singla, Tara S. Berenbaum, Aditya Anand & Paula Ravitz

  3. Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada

    Daisy R. Singla, Simone N. Vigod, Lucy C. Barker & Paula Ravitz

  4. Department of Psychiatry, Sinai Health, Toronto, Ontario, Canada

    Daisy R. Singla & Paula Ravitz

  5. Department of Obstetrics and Gynecology, Endeavor Health (formerly Northshore University HealthSystem), Evanston, IL, USA

    Richard K. Silver

  6. Department of Obstetrics and Gynecology, University of Chicago Pritzker School of Medicine, Chicago, IL, USA

    Richard K. Silver

  7. Department of Psychiatry, Women’s College Hospital, Toronto, Ontario, Canada

    Simone N. Vigod & Lucy C. Barker

  8. Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada

    Alex Kiss

  9. Department of Psychology, Vanderbilt University, Nashville, TN, USA

    Steven D. Hollon

  10. Department of Psychiatry, School of Medicine, University of North Carolina, Chapel Hill, NC, USA

    Bradley N. Gaynes, Crystal E. Schiller & Samantha Meltzer-Brody

  11. Department of Epidemiology, Gillings School of Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

    Bradley N. Gaynes

  12. Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA

    Vikram Patel

  13. Department of Global Health and Population, Harvard Chan School of Public Health, Boston, MA, USA

    Vikram Patel

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  1. Daisy R. Singla
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  2. Tara S. Berenbaum
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  3. Richard K. Silver
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  4. Simone N. Vigod
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  5. Siying Li
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  6. Aditya Anand
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  7. Sandeep Shelly
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  8. Alex Kiss
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  9. Andrea S. Lawson
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  10. Lucy C. Barker
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  11. Steven D. Hollon
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  14. Crystal E. Schiller
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D.R.S. conceptualized the study and designed the methodology, with significant contributions from V.P. and S.M.-B. D.R.S. and A.S.L. carried out funding acquisition. T.S.B., S.L., A.A. and S.S. performed data curation and cleaned the data. A.K., S.L., A.A. and S.S. conducted the formal analysis. D.R.S., S.M.-B., R.K.S., S.N.V., T.S.B. and A.S.L. managed and coordinated responsibility for the research activity planning and execution. D.R.S., S.M.-B., R.K.S. and S.N.V. provided oversight and leadership for the research activity planning and execution, with oversight from T.S.B. P.R. and C.E.S. oversaw the delivery of the clinical intervention. A.K., T.S.B., S.L., A.A. and S.S. verified the raw study data and had full access to the data. A.K. was responsible for the replication/reproducibility of results and other research outputs. D.R.S., A.S.L. and T.S.B. wrote the original draft of this paper, with inputs from V.P. S.M.-B., V.P., R.K.S., S.N.V., L.C.B., S.D.H., B.N.G., P.R. and C.E.S. reviewed and edited the subsequent drafts. All listed authors read and approved the final paper. D.R.S. and T.S.B. had final responsibility for the decision to submit for publication.

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Correspondence to Daisy R. Singla.

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Competing interests

The authors declare no competing interests. B.N.G reports compensation for authorship/reviewer for UpToDate chapters on depression; S.M.-B. receives research funding to UNC for pharmacologic clinical trials from Sage Therapeutics, Electromedical Products International and Sirtsei Pharmaceuticals. She also is a clinical advisor and professional corporation owner for Modern Health; S.N.V. reports royalties from UptoDate Inc for authorship of materials on depression and pregnancy.

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Nature Mental Health thanks Fiona L. Challacombe, L. G. Ward and Martha Zimmermann for their contribution to the peer review of this work.

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Singla, D.R., Berenbaum, T.S., Silver, R.K. et al. Treating comorbid post-traumatic stress and depression in perinatal populations: findings from a pragmatic randomized controlled trial. Nat. Mental Health (2025). https://doi.org/10.1038/s44220-025-00509-0

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