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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Participants will complete 5 writing sessions focused on their childbirth experience. 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.
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.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Stanford University
Palo Alto, California, United States
Percentage of participants initiating assigned treatment
Proportion of participants who begin their assigned intervention (≥1 session for WET; completion of initial training for CGRI)
Time frame: Baseline (up to 2 weeks)
Percentage of participants completing Written Exposure Therapy (WET)
Time frame: Baseline to Week 6
Percentage adherence to Written Exposure Therapy (WET)
Time frame: Baseline to Week 6
Percentage of participants completing Capnometry Guided Respiratory Intervention (CGRI)
Time frame: Baseline to Week 6
Percentage adherence to Capnometry Guided Respiratory Intervention (CGRI)
Time frame: 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.)
Time frame: 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.)
Time frame: Week 5
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.).
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Time frame: 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.)
Time frame: 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).
Time frame: 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.)
Time frame: 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).
Time frame: 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)
Time frame: 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.)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 6