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Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

Study acronym: TAPS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. 2 versions Re-verified since May 28, 2025, no change to tracked fieldsv10-v11
  2. Primary and study completion dates: Jul 2027 to Jul 31, 2027v9
  3. Primary and study completion dates: Jul 31, 2027 to Jul 2027
    • Eligibility criteria expanded, about 3 words
    • Study title expanded, about 1 word
    v8
  4. Primary and study completion dates: Sep 2027 to Jul 31, 2027
    • Study title expanded, about 2 words
    v7
  5. Study site revisedv6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2023 to Mar 1, 2023
    v5
  2. Start date: Feb 2023 to Mar 2023v4
  3. Start date: Dec 2022 to Feb 2023v3
  4. Secondary endpoints: 9 to 8v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Boston University
68 trials monitored
See 6 trials at risk
PTSD
889 trials monitored
See 54 trials at risk
The majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive mental health treatment despite the documented associations between PTSD and adverse pregnancy outcomes; this is likely due to workforce shortages, lack of data on the effectiveness of existing evidence-based treatment for PTSD in usual care obstetrics settings, and patient-level barriers to engagement such as stigma. The proposed study is a randomized controlled trial, which will examine the effectiveness of a brief evidence-based treatment for PTSD (i.e., Written Exposure Therapy) during pregnancy and the non-inferiority of delivery of this treatment by community health workers vs. delivery by mental health clinicians.
Trial Details
NCT Number NCT05486793
Lead Sponsor Boston University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 PTSD
Related terms Stress Disorders, Post-Traumatic
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov