An interventional study of Prolonged exposure therapy + incentives for therapy session attendance in Posttraumatic Stress Disorder and Pregnancy, sponsored by University of Vermont. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by University of Vermont · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients. The main question it aims to answer is:
Does PE+ decrease PTSD symptoms?
All participants will receive PE+ to see if their PTSD symptoms at the end of the trial are less than at the beginning.
Participants will:
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 30 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University of Vermont is the lead sponsor of 221 studies on the registry; 27 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Prolonged exposure therapy + incentives for therapy session attendance
Prolonged exposure therapy plus incentives for therapy session attendance
Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated
Change in posttraumatic stress disorder symptom severity as measured by Clinician Administered PTSD Scale (CAPS-5) for clinician-rated posttraumatic stress symptoms. The CAPS-5 is a 30-item structured interview. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 PTSD symptoms, each with severity scores ranging from 0-4. The overall total severity score for CAPS-5 ranges from 0-80, with lower scores representing better outcomes (less severe PTSD).
Time frame: From baseline to the 12-week assessment
Acceptability of prolonged exposure therapy + incentives for therapy session attendance
Change in treatment acceptability as measured by the Treatment Acceptability/Adherence Scale (TAAS). The TAAS is a 10-item scale, each with a range of 1-7 and some of which are reverse-scored. The total TAAS score is calculated by summing the score for the 10 TAAS items and the overall TAAS score ranges from 10-70, with higher scores representing better outcomes (greater treatment acceptability).
Time frame: From baseline to the 12-week assessment
Change in posttraumatic stress disorder symptom severity - self-reported
Change in posttraumatic stress disorder symptom severity as measured by PTSD Checklist for DSM-5 (PCL-5) for self-reported posttraumatic stress symptoms. The PCL-5 is a 20-item self-report measure that assesses the 20 symptoms of PTSD. The rating scale is 0-4 for each symptom/item, and overall scores range from 0-80, with lower scores representing better outcomes (less severe PTSD).
Time frame: From baseline to the 12-week assessment
Mean change in subjective units of distress
The mean change in subjective units of distress scale (SUDS) ratings from before each imaginal exposure exercise to the peak (highest) level of distress reported during the exercise measured with a single item (range: 0-100).
Time frame: Within 1-hour
Mean percent change in heart rate
The mean percent change in heart rate from before each imaginal exposure exercise to peak (highest) heart rate during the exercise
Time frame: Within 1-hour
Change in self-reported posttraumatic stress disorder symptom severity between PE sessions
The percentage of participants who have a reliable exacerbation in PTSD symptoms between sessions
Time frame: In the 1 week
Prolonged exposure therapy discontinuation
The percentage of participants who complete \<8 prolonged exposure therapy sessions
Time frame: From baseline to the 12-week assessment
Neonatal birth weight
Neonatal birth weight in grams
Time frame: Delivery
Gestational age at delivery
Gestational age at delivery in weeks
Time frame: Delivery
Maternal delivery complications
The percentage of participants who experience delivery complications (i.e., abruption/bleeding, hypertensive disorders, and preterm premature rupture of membranes or preterm labor)
Time frame: Delivery
Plan to share: Undecided
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Stress Disorders, Post-Traumatic →