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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT013866-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Arkansas | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postpartum Standard of Care | No Intervention | Participants will follow their current standard of care. | |
| Written Exposure Therapy (WET) | Experimental | 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. |
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| Capnometry-Guided Breathing Intervention (CGRI) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Pervez Sultan | Stanford University | Principal Investigator |
| Debra Kaysen | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Not yet recruiting | Little Rock | Arkansas | 72205 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication.
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).
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| 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. |
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| 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 |
| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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