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NCT07342530

Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy - Phase 1

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary endpoint(s) modified, enrollment reduced 86%.

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Record History

All 6 versions: 5 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 70 → 10 participants Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Primary completion moved earlier from Dec 2027 to Jan 2027
    • Study completion moved earlier from Dec 2027 to Mar 2027
    • Trial arms changed: 3 → 2
    • Secondary endpoints: 15 to 7
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 3 words
  2. Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 12 of 15 entries
    • Site contacts updated at 1 of 2 sites
  3. Recruitment opened
    • Start date changed from estimate of Feb 2026 to Mar 9, 2026
    • Site details revised at 2 of 2 sites
    v4
  4. Study title shortened, about 1 wordv2
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percentage of participants initiating assigned treatment
Timeframe: Baseline (up to 2 weeks)
Percentage of participants completing Written Exposure Therapy (WET)
Timeframe: Baseline to Week 6
Percentage adherence to Written Exposure Therapy (WET)
Timeframe: Baseline to Week 6
Percentage of participants completing Capnometry Guided Respiratory Intervention (CGRI)
Timeframe: Baseline to Week 6
Percentage adherence to Capnometry Guided Respiratory Intervention (CGRI)
Timeframe: Baseline to Week 6

Secondary (7)

Change from baseline in PTSD Checklist for DSM-5 (PCL-5) Scale Score
Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) Scale Score
Change from baseline in Whole Person Health Index (WPHI) Scale Score
Change from baseline in Generalized Anxiety Disorder Questionaire (GAD-7)
Change from baseline in Maternal-infant bonding (MIBS) Scale Score
Show 2 moreShow less
Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score
Change from baseline in Breastfeeding Self-Efficacy Scale-Short Form (BFSES-SF)

Arms and interventions

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.

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.

Behavioral: Written Exposure Therapy (WET)

Devices: Capnometry-Guided Breathing Intervention (CGRI)

Sites

2 sites in 1 country