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. 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
NOT_YET_RECRUITINGStanford University
Palo Alto, California, United States
RECRUITINGPercentage 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