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NCT Number: NCT07342530

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

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.

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Key information

Conditions

Written Exposure Therapy Breathing Techniques Mental Disorders PTSD (Childbirth-Related) Postpartum Care Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Written Exposure Therapy (WET)

Behavioral

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)

Device

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.

Other names: Freespira

Primary outcomes

  1. 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)

  2. Percentage of participants completing Written Exposure Therapy (WET)

    Time frame: Baseline to Week 6

  3. Percentage adherence to Written Exposure Therapy (WET)

    Time frame: Baseline to Week 6

  4. Percentage of participants completing Capnometry Guided Respiratory Intervention (CGRI)

    Time frame: Baseline to Week 6

  5. Percentage adherence to Capnometry Guided Respiratory Intervention (CGRI)

    Time frame: Baseline to Week 6

  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.)

  7. 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.)

Secondary outcomes

  1. 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 in PTSD symptoms during past week measured by the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report measure. (Score range 0 - 80, higher scores indicating greater severity of PTSD symptoms.).

  2. 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

    Participants complete the EPDS questionnaire, a 10-item scale assessing postpartum depressive symptoms over the past 7 days. (Score range 0 - 30, higher scores represents greater symptom severity.)

  3. Change from baseline in Whole Person Health Index (WPHI) Scale Score

    Time frame: Baseline, Week 3, Week 6, Week 12

    Participants complete WHPI questionaire, a 9 item scale assessing global health and functioning. (Score range 9 - 81, higher scores represent better health).

  4. Change from baseline in Generalized Anxiety Disorder Questionaire (GAD-7)

    Time frame: Baseline, Week 3, Week 6, Week 12

    Participants complete the GAD-7, a 7-item scale assessing anxiety symptoms over 2 weeks. (Score range 0 - 21, higher scores represent greater anxiety severity.)

  5. Change from baseline in Maternal-infant bonding (MIBS) Scale Score

    Time frame: Baseline, Week 3, Week 6, Week 12

    Participants complete the MIBS questionaire, an 8 item measure of bonding difficulties over the past few weeks (Score range 0 - 24, higher scores represent greater bonding impairment).

  6. Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score

    Time frame: Baseline, Week 3, Week 6, Week 12

    Participants complete the STORK questionnaire, a 47-item scale assessing postpartum recovery over the past 7 days. (Score range 0 - 188, higher score represents a greater degree of recovery)

  7. Change from baseline in Breastfeeding Self-Efficacy Scale-Short Form (BFSES-SF)

    Time frame: Baseline, Week 3, Week 6, Week 12

    Participants complete the BFSES-SF, a 14-item measure of breastfeeding self-efficacy (Score range 14 - 70, higher scores indicate greater breastfeeding confidence.)

  8. Percentage of participants completing hair sample collection at Baseline and Week 6

    Time frame: Baseline, Week 6

    Participants have hair samples collected at baseline and at Week 6 post treatment.

  9. Change in hair cortisol concentration between Baseline and Week 6

    Time frame: Baseline, Week 6

    Participants have hair samples collected at baseline and at Week 6 post treatment. Hair steroid concentrations reflect average systemic hormone exposure over the preceding weeks. Change in hair cortisol concentration from Baseline to Week 6

  10. Change in hair cortisone concentration between Baseline and Week 6

    Time frame: Baseline, Week 6

    Participants have hair samples collected at baseline and at Week 6 post treatment. Hair steroid concentrations reflect average systemic hormone exposure over the preceding weeks. Change in hair cortisone concentration from Baseline to Week 6

  11. Change in hair testosterone concentration between Baseline and Week 6

    Time frame: Baseline, Week 6

    Participants have hair samples collected at baseline and at Week 6 post treatment. Hair steroid concentrations reflect average systemic hormone exposure over the preceding weeks. Change in hair testosterone concentration from Baseline to Week 6

  12. Change in hair progesterone concentration between Baseline and Week 6

    Time frame: Baseline, Week 6

    Participants have hair samples collected at baseline and at Week 6 post treatment. Hair steroid concentrations reflect average systemic hormone exposure over the preceding weeks. Change in hair progesterone concentration from Baseline to Week 6

  13. Change in hair corticosterone concentration between Baseline and Week 6

    Time frame: Baseline, Week 6

    Participants have hair samples collected at baseline and at Week 6 post treatment. Hair steroid concentrations reflect average systemic hormone exposure over the preceding weeks. Change in hair corticosterone concentration from Baseline to Week 6

  14. Change in hair dehydroepiandrosterone (DHEA) concentration between Baseline and Week 6

    Time frame: Baseline, Week 6

    Participants have hair samples collected at baseline and at Week 6 post treatment. Hair steroid concentrations reflect average systemic hormone exposure over the preceding weeks. Change in hair dehydroepiandrosterone (DHEA) concentration values from Baseline to Week 6

  15. Change in hair androstenedione concentration between Baseline and Week 6

    Time frame: Baseline, Week 6

    Participants have hair samples collected at baseline and at Week 6 post treatment. Hair steroid concentrations reflect average systemic hormone exposure over the preceding weeks. Change in hair androstenedione concentration from Baseline to Week 6

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • University of Arkansas

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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