NCT07342530 · Stanford University
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
What this study is 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
DEVICE
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 measures
Percentage of participants initiating assigned treatment
Time frame: Baseline (up to 2 weeks)
Proportion of participants who begin their assigned intervention (≥1 session for WET; completion of initial training for CGRI)
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
Participant satisfaction measured using the CSQ-8 questionaire, an 8-item scale. (Scale score 8 - 32. Higher scores represent greater satisfaction with treatment.)
Treatment credibility using the Opinion About Treatment (OAT) form
Time frame: Week 5
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.)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Delivered a live infant within 5 days
- Severe maternal morbidity or infant admitted to NICU
- 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
Where
- Little Rock, Arkansas
- Palo Alto, California
Collaborators
University of Arkansas, National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2026 · Source of record for eligibility and locations