Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18
Delivered a live infant within 5 days
Severe maternal morbidity or infant admitted to NICU
PCL-5 ≥28
Disqualifiers
Active psychosis or mania
Current suicidal crisis
Current suicidal intent or plan
Cognitive impairment preventing participation
Trial design
Design model
Parallel
Treatments tested in this trial
Written Exposure Therapy (WET)
BehavioralParticipants 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)
DeviceParticipants 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.
Treatment groups
70 Participants
are divided into 3 treatment groupsGroup A: Postpartum Standard of CareNo intervention 0 interventions
Group B: Written Exposure Therapy (WET)Experimental treatment 1 intervention
Group C: Capnometry-Guided Breathing Intervention (CGRI)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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)
Time frame
Baseline (up to 2 weeks)2
Percentage of participants completing Written Exposure Therapy (WET)
Time frame
Baseline to Week 63
Percentage adherence to Written Exposure Therapy (WET)
Time frame
Baseline to Week 64
Percentage of participants completing Capnometry Guided Respiratory Intervention (CGRI)
Time frame
Baseline to Week 6Secondary outcomes
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.).
Time frame
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 122
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 123
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 124
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 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
University of Arkansas
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov