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Recruiting NCT07342530

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

No phase Interventional Written Exposure Therapy Breathing Techniques PTSD (Childbirth-Related) Postpartum Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Written Exposure Therapy (WET), Capnometry-Guided Breathing Intervention (CGRI).
Who it may be relevant to
Registry conditions: Written Exposure Therapy, Breathing Techniques, PTSD (Childbirth-Related), Postpartum Care. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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)]
  • 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]
Secondary outcome measures (12)
  • Change from baseline in PTSD Checklist for DSM-5 (PCL-5) Scale Score [Time frame: 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 [Time frame: 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 [Time frame: Baseline, Week 3, Week 6, Week 12]
  • Change from baseline in Generalized Anxiety Disorder Questionaire (GAD-7) [Time frame: Baseline, Week 3, Week 6, Week 12]
  • Change from baseline in Maternal-infant bonding (MIBS) Scale Score [Time frame: Baseline, Week 3, Week 6, Week 12]
  • Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score [Time frame: Baseline, Week 3, Week 6, Week 12]
  • Change from baseline in Breastfeeding Self-Efficacy Scale-Short Form (BFSES-SF) [Time frame: Baseline, Week 3, Week 6, Week 12]
  • Percentage of participants completing hair sample collection at Baseline and Week 6 [Time frame: Baseline, Week 6]
  • Change in hair cortisol concentration between Baseline and Week 6 [Time frame: Baseline, Week 6]
  • Change in hair cortisone concentration between Baseline and Week 6 [Time frame: Baseline, Week 6]
  • Change in hair testosterone concentration between Baseline and Week 6 [Time frame: Baseline, Week 6]
  • Change in hair progesterone concentration between Baseline and Week 6 [Time frame: Baseline, Week 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University of Arkansas for Medical Sciences — Little Rock
  • Stanford University — Palo Alto

Identifiers

NCT: NCT07342530 · 80498 · R01AT013866-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗