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

Stanford University

Status: Not yet enrolling

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

Treatments: Device: Capnometry-Guided Breathing Intervention (CGRI); Behavioral: Written Exposure Therapy (WET)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07342530

80498

R01AT013866-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

Postpartum Standard of Care

No Intervention group

Description:

Participants will follow their current standard of care.

Written Exposure Therapy (WET)

Experimental group

Description:

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.

Treatment:

Behavioral: Written Exposure Therapy (WET)

Capnometry-Guided Breathing Intervention (CGRI)

Experimental group

Description:

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.

Treatment:

Device: Capnometry-Guided Breathing Intervention (CGRI)