Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Vermont
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Male
Under 18 years old
Gestational age > 25 weeks
No current diagnosis of PTSD
Trial design
Design model
Single group
Treatments tested in this trial
Prolonged exposure therapy + incentives for therapy session attendance
BehavioralProlonged exposure therapy plus incentives for therapy session attendance
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Prolonged exposure therapy + incentives for therapy session attendanceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 assessment2
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 assessmentSecondary outcomes
1
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 assessment2
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-hour3
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-hour4
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 weekSponsors and contacts
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Source ClinicalTrials.gov