Breathing Techniques, Postpartum Care, PTSD (Childbirth-Related), Written Exposure Therapy
Conditions
Brief 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.
Interventions
BEHAVIORALWritten 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.
DEVICECapnometry-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.
Sponsors
Stanford University
University of Arkansas
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants initiating assigned treatment | Baseline (up to 2 weeks) | Proportion of participants who begin their assigned intervention (≥1 session for WET; completion of initial training for CGRI) |
| 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) | 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.) |
| Treatment credibility using the Opinion About Treatment (OAT) form | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in PTSD Checklist for DSM-5 (PCL-5) Scale Score | 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.). |
| Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) Scale Score | 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.) |
| Change from baseline in Whole Person Health Index (WPHI) Scale Score | 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). |
| Change from baseline in Generalized Anxiety Disorder Questionaire (GAD-7) | 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.) |
| Change from baseline in Maternal-infant bonding (MIBS) Scale Score | 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). |
| Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score | 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) |
| Change from baseline in Breastfeeding Self-Efficacy Scale-Short Form (BFSES-SF) | 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.) |
| Percentage of participants completing hair sample collection at Baseline and Week 6 | Baseline, Week 6 | Participants have hair samples collected at baseline and at Week 6 post treatment. |
| Change in hair cortisol concentration between Baseline and Week 6 | 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 |
| Change in hair cortisone concentration between Baseline and Week 6 | 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 |
| Change in hair testosterone concentration between Baseline and Week 6 | 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 |
| Change in hair progesterone concentration between Baseline and Week 6 | 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 |
| Change in hair corticosterone concentration between Baseline and Week 6 | 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 |
| Change in hair dehydroepiandrosterone (DHEA) concentration between Baseline and Week 6 | 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 |
| Change in hair androstenedione concentration between Baseline and Week 6 | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPervez Sultan
Stanford University
PRINCIPAL_INVESTIGATORDebra Kaysen
Stanford University
Outcome results
None listed