Early Support for Post-Traumatic Stress Disorder After Difficult Childbirth: Writing and Breathing Interventions
NCT ID: NCT07342530
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2026-02-28
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Postpartum Standard of Care
Participants will follow their current standard of care.
No interventions assigned to this group
Written Exposure Therapy (WET)
Participants will complete 5 writing sessions focused on their childbirth experience. One 50-minute session will be held in the hospital before discharge, followed by four 50-minute sessions by secure video once a week. Sessions are delivered by a trained study therapist under licensed clinician supervision.
Written Exposure Therapy (WET)
Participants will complete 5 writing sessions focused on their childbirth experience. One 50-minute session will be held in the hospital before discharge, followed by four 50-minute sessions by secure video once a week. Sessions are delivered by a trained study therapist under licensed clinician supervision.
Capnometry-Guided Breathing Intervention (CGRI)
Participants will complete one 45-minute in-hospital training session using the device, which includes a tablet and breathing sensor. They will then practice guided breathing at home twice daily for about 17 minutes each time for 4 weeks, with weekly phone check-ins from study staff.
Capnometry-Guided Breathing Intervention (CGRI)
Participants will complete one 45-minute in-hospital training session using the device, which includes a tablet and breathing sensor. They will then practice guided breathing at home twice daily for about 17 minutes each time for 4 weeks, with weekly phone check-ins from study staff.
Interventions
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Written Exposure Therapy (WET)
Participants will complete 5 writing sessions focused on their childbirth experience. One 50-minute session will be held in the hospital before discharge, followed by four 50-minute sessions by secure video once a week. Sessions are delivered by a trained study therapist under licensed clinician supervision.
Capnometry-Guided Breathing Intervention (CGRI)
Participants will complete one 45-minute in-hospital training session using the device, which includes a tablet and breathing sensor. They will then practice guided breathing at home twice daily for about 17 minutes each time for 4 weeks, with weekly phone check-ins from study staff.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Delivered a live infant within 5 days
* Severe maternal morbidity or infant admitted to NICU
* PCL-5 ≥28
* English-speaking
* Able to consent and participate
Exclusion Criteria
* Current suicidal crisis
* Current suicidal intent or plan
* Cognitive impairment preventing participation
18 Years
FEMALE
No
Sponsors
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University of Arkansas
OTHER
National Center for Complementary and Integrative Health (NCCIH)
NIH
Stanford University
OTHER
Responsible Party
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Pervez Sultan
Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)
Principal Investigators
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Pervez Sultan
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Debra Kaysen
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Stanford University
Palo Alto, California, United States
Countries
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Other Identifiers
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80498
Identifier Type: -
Identifier Source: org_study_id
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