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Written Exposure TherapyNCT07342530

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

A study testing Written Exposure Therapy (WET) and Capnometry-Guided Breathing Intervention (CGRI) in people with Written Exposure Therapy and Breathing Techniques, run by Stanford University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Written Exposure Therapy (WET) and Capnometry-Guided Breathing Intervention (CGRI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesUnited States
Study dates
9 Mar 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Active psychosis or mania
  • Current suicidal crisis
  • Current suicidal intent or plan
  • Cognitive impairment preventing participation

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Heather Moody, 501-526-4333, HLMoody@uams.edu

    Not yet recruiting

  • Stanford University

    Palo Alto, California, 94304

    Guillermina Ferrea, +44 7541 485299, gferrea@stanford.edu

    Aleesha Jethwa, +44 7857 907762, Ajethwa1@stanford.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Written Exposure Therapy (WET), Capnometry-Guided Breathing Intervention (CGRI)
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Written Exposure Therapy (WET)Behavioural

    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

    Also called Freespira

    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.

Study groups in NCT07342530
Study groupRoleWhat they receive
Postpartum Standard of CareNo interventionParticipants will follow their current standard of care.
Written Exposure Therapy (WET)ExperimentalParticipants 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.
Receives: Behavioral: Written Exposure Therapy (WET)
Capnometry-Guided Breathing Intervention (CGRI)ExperimentalParticipants 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.
Receives: Device: Capnometry-Guided Breathing Intervention (CGRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants initiating assigned treatment

    Proportion of participants who begin their assigned intervention (≥1 session for WET; completion of initial training for CGRI)

    Measured: Baseline (up to 2 weeks)

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

    Measured: Baseline to Week 6

  3. Percentage adherence to Written Exposure Therapy (WET)

    Measured: Baseline to Week 6

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

    Measured: Baseline to Week 6

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

    Measured: Baseline to Week 6

  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.)

    Measured: Week 5

  7. 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.)

    Measured: Week 5

Secondary outcomes (15)

  1. 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.).

    Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 12

  2. 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.)

    Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 12

  3. 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).

    Measured: Baseline, Week 3, Week 6, Week 12

  4. 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.)

    Measured: Baseline, Week 3, Week 6, Week 12

  5. 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).

    Measured: Baseline, Week 3, Week 6, Week 12

  6. 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)

    Measured: Baseline, Week 3, Week 6, Week 12

  7. 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.)

    Measured: Baseline, Week 3, Week 6, Week 12

  8. 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.

    Measured: Baseline, Week 6

  9. 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

    Measured: Baseline, Week 6

  10. 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

    Measured: Baseline, Week 6

  11. 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

    Measured: Baseline, Week 6

  12. 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

    Measured: Baseline, Week 6

  13. 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

    Measured: Baseline, Week 6

  14. 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

    Measured: Baseline, Week 6

  15. 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

    Measured: Baseline, Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start9 Mar 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07342530
Sponsor's protocol ID
80498
Other IDs
R01AT013866-01
Status last verified
Oct 2026
First submitted
9 Jan 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Questions about this trial

What is this clinical trial studying?

A study testing Written Exposure Therapy (WET) and Capnometry-Guided Breathing Intervention (CGRI) in people with Written Exposure Therapy and Breathing Techniques, run by Stanford University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants initiating assigned treatment (time frame: Baseline (up to 2 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07342530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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