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Behavioral Intervention
Prolonged Exposure Therapy for Post-Traumatic Stress Disorder
N/A
Waitlist Available
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5
Female
Must not have
No current diagnosis of PTSD
Male
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if a treatment called prolonged exposure + incentives (PE+) can help pregnant individuals with PTSD and opioid use disorder. Participants will receive PE+ therapy for 1 hour weekly for
Who is the study for?
This trial is for pregnant individuals who are undergoing treatment for opioid use disorder and also have PTSD. They must be willing to attend weekly therapy sessions for 12 weeks and allow access to their medical records post-delivery.
What is being tested?
The study tests whether prolonged exposure therapy, combined with financial incentives for attendance, can reduce PTSD symptoms in the participants over the course of the trial.
What are the potential side effects?
While not explicitly stated, potential side effects may include emotional distress or increased anxiety due to revisiting traumatic events during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PTSD according to the DSM-5.
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I am female.
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I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a current diagnosis of PTSD.
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I am male.
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I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to the 12-week assessment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to the 12-week assessment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of prolonged exposure therapy + incentives for therapy session attendance
Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated
Secondary study objectives
Change in opioid craving
Change in posttraumatic stress disorder symptom severity - self-reported
Change in self-reported posttraumatic stress disorder symptom severity between PE sessions
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prolonged exposure therapy + incentives for therapy session attendanceExperimental Treatment1 Intervention
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Who is running the clinical trial?
University of VermontLead Sponsor
277 Previous Clinical Trials
3,744,084 Total Patients Enrolled
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