Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- University of Vermont
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated
- Status
- Not yet recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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:
- Receive individual PE+ therapy for 1 hour weekly for 12 weeks.
- Receive financial incentives for attending each PE+ session.
- Attend assessment visits every 4 weeks for the 12 weeks of the trial.
- Allow research staff to collect some information about their labor and delivery from their medical records after their babies are born.
Investigators
Kelly Peck
Professor
University of Vermont
Eligibility Criteria
Inclusion Criteria
- •\>18 years old
- •Gestational age ≤ 25 weeks
- •Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5
- •Participants receiving psychotropic medications must be maintained on a stable dose for \>14 days prior to enrollment.
Exclusion Criteria
- •Under 18 years old
- •Gestational age \> 25 weeks
- •No current diagnosis of PTSD
- •Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview
- •Enrolled in another ongoing evidence-based treatment for PTSD.
Outcomes
Primary Outcomes
Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated
Time Frame: From baseline to the 12-week assessment
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).
Acceptability of prolonged exposure therapy + incentives for therapy session attendance
Time Frame: From baseline to the 12-week assessment
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).
Secondary Outcomes
- Change in posttraumatic stress disorder symptom severity - self-reported(From baseline to the 12-week assessment)
- Mean change in subjective units of distress(Within 1-hour)
- Mean percent change in heart rate(Within 1-hour)
- Change in self-reported posttraumatic stress disorder symptom severity between PE sessions(In the 1 week)
- Prolonged exposure therapy discontinuation(From baseline to the 12-week assessment)
- Neonatal birth weight(Delivery)
- Gestational age at delivery(Delivery)
- Maternal delivery complications(Delivery)