Clinical trial NCT06670079: Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients Receiving Medications for Opioid Use Disorder
Official title: Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients Receiving Medications for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Opioid Use Disorder
Pregnancy
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated
timeFrame: From baseline to the 12-week assessment
measure: Acceptability of prolonged exposure therapy + incentives for therapy session attendance
timeFrame: From baseline to the 12-week assessment
Secondary outcomes:
measure: Change in posttraumatic stress disorder symptom severity - self-reported
timeFrame: From baseline to the 12-week assessment
measure: Mean change in subjective units of distress
timeFrame: Within 1-hour
measure: Mean percent change heart rate reactivity
timeFrame: Within 1-hour
measure: Change in opioid craving
timeFrame: Within 1-hour
measure: Change in self-reported posttraumatic stress disorder symptom severity between PE sessions
timeFrame: In the 1 week
measure: Prolonged exposure therapy discontinuation
timeFrame: From baseline to the 12-week assessment
measure: Neonatal birth weight
timeFrame: Delivery
measure: Gestational age at delivery
timeFrame: Delivery
measure: Maternal delivery complications
timeFrame: Delivery
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References: