Recruiting

Written Exposure Therapy & Capnometry Guided Breathing

Sponsor:

Stanford University

Code:

NCT07342530

Conditions

Written Exposure Therapy

Breathing Techniques

PTSD (Childbirth-Related)

Postpartum Care

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Written Exposure Therapy (WET)

Capnometry-Guided Breathing Intervention (CGRI)

Study Details

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

Study ID

NCT07342530

Start date

Mar 9, 2026

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Postpartum Standard of Care

Participants will follow their current standard of care.

experimental: Written Exposure Therapy (WET)

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.

experimental: 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

Written Exposure Therapy (WET)

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.

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.

Primary outcome measure

  • Percentage of participants initiating assigned treatment [ Time Frame: Baseline (up to 2 weeks) ]
  • Percentage of participants completing Written Exposure Therapy (WET) [ Time Frame: Baseline to Week 6 ]
  • Percentage adherence to Written Exposure Therapy (WET) [ Time Frame: Baseline to Week 6 ]
  • Percentage of participants completing Capnometry Guided Respiratory Intervention (CGRI) [ Time Frame: Baseline to Week 6 ]
  • Percentage adherence to Capnometry Guided Respiratory Intervention (CGRI) [ Time Frame: Baseline to Week 6 ]
  • Participant Satisfaction Scale Score using Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Week 5 ]
  • Treatment credibility using the Opinion About Treatment (OAT) form [ Time Frame: Week 5 ]

Central Contacts and Locations

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Aleesha J Jethwa

650-723-5439ajethwa1@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Apr 24, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-04-24.