Posttraumatic Stress Disorder, Pregnancy
Conditions
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.
Interventions
BEHAVIORALProlonged exposure therapy + incentives for therapy session attendance
Prolonged exposure therapy plus incentives for therapy session attendance
Sponsors
University of Vermont
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * \>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
* Male * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in posttraumatic stress disorder symptom severity - self-reported | From baseline to the 12-week assessment | 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). |
| Mean change in subjective units of distress | Within 1-hour | 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). |
| Mean percent change in heart rate | Within 1-hour | The mean percent change in heart rate from before each imaginal exposure exercise to peak (highest) heart rate during the exercise |
| Change in self-reported posttraumatic stress disorder symptom severity between PE sessions | In the 1 week | The percentage of participants who have a reliable exacerbation in PTSD symptoms between sessions |
| Prolonged exposure therapy discontinuation | From baseline to the 12-week assessment | The percentage of participants who complete \<8 prolonged exposure therapy sessions |
| Neonatal birth weight | Delivery | Neonatal birth weight in grams |
| Gestational age at delivery | Delivery | Gestational age at delivery in weeks |
| Maternal delivery complications | Delivery | The percentage of participants who experience delivery complications (i.e., abruption/bleeding, hypertensive disorders, and preterm premature rupture of membranes or preterm labor) |
Countries
United States
Contacts
CONTACTKelly Peck, PhD
Outcome results
None listed