Early Support for Post-Traumatic Stress Disorder After Difficult Childbirth: Writing and Breathing Interventions

NCT ID: NCT07342530

Last Updated: 2026-01-15

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-12-31

Brief Summary

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The purpose of this study is to examine two early interventions, Written Exposure Therapy and Capnometry Guided Breathing, to reduce post-traumatic stress disorder (PTSD) symptoms in women after childbirth as compared to usual care.

Detailed Description

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Conditions

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Written Exposure Therapy Breathing Techniques PTSD (Childbirth-Related) Postpartum Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Postpartum Standard of Care

Participants will follow their current standard of care.

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

Written Exposure Therapy (WET)

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Capnometry-Guided Breathing Intervention (CGRI)

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

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.

Intervention Type DEVICE

Other Intervention Names

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Freespira

Eligibility Criteria

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Inclusion Criteria

* Age ≥18
* 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

* Active psychosis or mania
* Current suicidal crisis
* Current suicidal intent or plan
* Cognitive impairment preventing participation
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Pervez Sultan

Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01AT013866-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

80498

Identifier Type: -

Identifier Source: org_study_id

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