Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy

NCT07342530 | Recruiting DMC FDA Device

• 2 other identifiers: 80498R01AT013866-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Percentage of participants initiating assigned treatment

  Proportion of participants who begin their assigned intervention (≥1 session for WET; completion of initial training for CGRI)

  Baseline (up to 2 weeks)

• Percentage of participants completing Written Exposure Therapy (WET)

  Baseline to Week 6

• Percentage adherence to Written Exposure Therapy (WET)

  Baseline to Week 6

• Percentage of participants completing Capnometry Guided Respiratory Intervention (CGRI)

  Baseline to Week 6

• Percentage adherence to Capnometry Guided Respiratory Intervention (CGRI)

  Baseline to Week 6

• Participant Satisfaction Scale Score using Client Satisfaction Questionnaire (CSQ-8)

  Participant satisfaction measured using the CSQ-8 questionaire, an 8-item scale. (Scale score 8 - 32. Higher scores represent greater satisfaction with treatment.)

  Week 5

• Treatment credibility using the Opinion About Treatment (OAT) form

  Participant perceptions of treatment credibility will be measured using the OAT form. (Scale score 3 - 27. Higher scores represent greater perceived credibility of the intervention.)

  Week 5

Secondary Outcomes (15)

• Change from baseline in PTSD Checklist for DSM-5 (PCL-5) Scale Score

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 12

• Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) Scale Score

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 12

• Change from baseline in Whole Person Health Index (WPHI) Scale Score

  Baseline, Week 3, Week 6, Week 12

• Change from baseline in Generalized Anxiety Disorder Questionaire (GAD-7)

  Baseline, Week 3, Week 6, Week 12

• Change from baseline in Maternal-infant bonding (MIBS) Scale Score

  Baseline, Week 3, Week 6, Week 12

Study Arms (3)

Postpartum Standard of Care

NO INTERVENTION

Participants will follow their current standard of care.

Written Exposure Therapy (WET)

EXPERIMENTAL

Participants will complete 5 writing sessions. 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.

Behavioral: Written Exposure Therapy (WET)

Capnometry-Guided Breathing Intervention (CGRI)

EXPERIMENTAL

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.

Device: Capnometry-Guided Breathing Intervention (CGRI)

Interventions

Written Exposure Therapy (WET) BEHAVIORAL

Participants will complete 5 writing sessions. 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)

Capnometry-Guided Breathing Intervention (CGRI) 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.

Also known as: Freespira

Capnometry-Guided Breathing Intervention (CGRI)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active psychosis or mania
• Current suicidal crisis
• Current suicidal intent or plan
• Cognitive impairment preventing participation

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Stanford University: lead
• University of Arkansas: collaborator

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

NOT YET RECRUITING

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Pervez Sultan

  Stanford University

  PRINCIPAL INVESTIGATOR

• Debra Kaysen

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 15, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Wish whom? Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For what types of analysis? For individual participant data meta-analysis By what mechanism will data be made available? Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided).

Locations

US (2)