Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant People Receiving Medications for Opioid Use Disorder

Not Applicable

Not yet recruiting

• Conditions: Posttraumatic Stress Disorder; Opioid Use Disorder; Pregnancy

• Registration Number: NCT06670079
• Lead Sponsor: University of Vermont

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 people who are already receiving treatment for opioid use disorder. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01
• Study Start: 2025-03-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Female
• >18 years old
• Gestational age ≤ 25 weeks
• Maintained on a stable methadone or buprenorphine dose for >14 days prior to the study
• 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.

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Exclusion Criteria

• Male
• Under 18 years old
• Gestational age > 25 weeks
• Not receiving medication for opioid use disorder
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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 percent change heart rate reactivity	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 opioid craving	Within 1-hour	Craving ratings will be assessed using a single item measure (range: 0-100) of craving for opioids. The mean change in craving will be assessed from before each imaginal exposure exercise to the end of the session
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)

Trial Locations

Locations (1)

University of Vermont; 🇺🇸 Burlington, Vermont, United States