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Search / Trial NCT06670079

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

Launched by UNIVERSITY OF VERMONT · Oct 31, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called prolonged exposure therapy plus incentives (PE+) to see if it can help pregnant people who have posttraumatic stress disorder (PTSD) and are receiving medication for opioid use disorder. The main goal is to find out if this therapy can reduce PTSD symptoms in these individuals. All participants will receive therapy sessions for one hour each week for 12 weeks and will also get financial incentives for attending these sessions. Additionally, they will have check-in visits every four weeks throughout the trial and will allow researchers to access some information about their labor and delivery after their babies are born.

To participate in this trial, you need to be a female over 18 years old who is less than 25 weeks pregnant and has been on a stable dose of methadone or buprenorphine for at least two weeks. You must also have a current diagnosis of PTSD. However, individuals who are male, under 18, more than 25 weeks pregnant, not receiving medication for opioid use disorder, or currently experiencing certain mental health issues will not be eligible. This trial is not yet recruiting participants, but it offers a supportive opportunity for individuals facing these challenges during pregnancy.

Gender

FEMALE

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.

About University Of Vermont

The University of Vermont (UVM) is a leading academic institution known for its commitment to advancing healthcare through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, UVM leverages its diverse expertise in medicine, public health, and biomedical sciences to conduct cutting-edge clinical studies. The university aims to translate scientific findings into effective treatments and interventions, ultimately improving patient outcomes and contributing to the broader medical community. UVM's research facilities and access to a wide patient population support its mission to foster a culture of inquiry and excellence in clinical research.

Locations

Burlington, Vermont, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported