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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged exposure therapy + incentives for therapy session attendance | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged exposure therapy + incentives for therapy session attendance | Behavioral | Prolonged exposure therapy plus incentives for therapy session attendance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | From baseline to the 12-week assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly Peck, PhD | Contact | 802-656-9610 | kelly.peck@uvm.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont | Recruiting | Burlington | Vermont | 05401 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| 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). | 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 | 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 | In the 1 week |
| Prolonged exposure therapy discontinuation | The percentage of participants who complete <8 prolonged exposure therapy sessions | From baseline to the 12-week assessment |
| Neonatal birth weight | Neonatal birth weight in grams | Delivery |
| Gestational age at delivery | Gestational age at delivery in weeks | 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) | Delivery |