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

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Care; Written Exposure Therapy; PTSD (Childbirth-Related); Breathing Techniques
• Intervention / Treatment: Device: Capnometry-Guided Breathing Intervention (CGRI); Behavioral: Written Exposure Therapy (WET)

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Not yet recruiting
      • University of Arkansas for Medical Sciences
      • Contact: Heather Moody; Phone Number: 501-526-4333; Email: HLMoody@uams.edu
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Aleesha J Jethwa; Phone Number: 650-723-5439; Email: ajethwa1@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Postpartum Standard of Care; Participants will follow their current standard of care.
Experimental: 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.	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.; Other Names: Freespira
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants initiating assigned treatment	Proportion of participants who begin their assigned intervention (≥1 session for WET; completion of initial training for CGRI)	Baseline (up to 2 weeks)
Percentage of participants completing Written Exposure Therapy (WET)		Baseline to Week 6
Percentage adherence to Written Exposure Therapy (WET)		Baseline to Week 6
Percentage of participants completing Capnometry Guided Respiratory Intervention (CGRI)		Baseline to Week 6
Percentage adherence to Capnometry Guided Respiratory Intervention (CGRI)		Baseline to Week 6
Participant Satisfaction Scale Score using Client Satisfaction Questionnaire (CSQ-8)	Participant satisfaction measured using the CSQ-8 questionaire, an 8-item scale. (Scale score 8 - 32. Higher scores represent greater satisfaction with treatment.)	Week 5
Treatment credibility using the Opinion About Treatment (OAT) form	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.)	Week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in PTSD Checklist for DSM-5 (PCL-5) Scale Score	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.).	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	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.)	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	Participants complete WHPI questionaire, a 9 item scale assessing global health and functioning. (Score range 9 - 81, higher scores represent better health).	Baseline, Week 3, Week 6, Week 12
Change from baseline in Generalized Anxiety Disorder Questionaire (GAD-7)	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.)	Baseline, Week 3, Week 6, Week 12
Change from baseline in Maternal-infant bonding (MIBS) Scale Score	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).	Baseline, Week 3, Week 6, Week 12
Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score	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)	Baseline, Week 3, Week 6, Week 12
Change from baseline in Breastfeeding Self-Efficacy Scale-Short Form (BFSES-SF)	Participants complete the BFSES-SF, a 14-item measure of breastfeeding self-efficacy (Score range 14 - 70, higher scores indicate greater breastfeeding confidence.)	Baseline, Week 3, Week 6, Week 12
Percentage of participants completing hair sample collection at Baseline and Week 6	Participants have hair samples collected at baseline and at Week 6 post treatment.	Baseline, Week 6
Change in hair cortisol concentration between Baseline and 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	Baseline, Week 6
Change in hair cortisone concentration between Baseline and 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	Baseline, Week 6
Change in hair testosterone concentration between Baseline and 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	Baseline, Week 6
Change in hair progesterone concentration between Baseline and 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	Baseline, Week 6
Change in hair corticosterone concentration between Baseline and 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	Baseline, Week 6
Change in hair dehydroepiandrosterone (DHEA) concentration between Baseline and 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	Baseline, Week 6
Change in hair androstenedione concentration between Baseline and 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	Baseline, Week 6

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); University of Arkansas
• Investigators: Principal Investigator: Pervez Sultan, Stanford University; Principal Investigator: Debra Kaysen, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 80498; R01AT013866-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Wish whom? Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For what types of analysis? For individual participant data meta-analysis By what mechanism will data be made available? Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No