RecruitingNot ApplicableNCT06288711

Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD


Sponsor

University of Vermont

Enrollment

135 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • \>18 years old
  • Maintained on a stable methadone or buprenorphine dose for \>1 month 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 \>1 month prior to enrollment.

Exclusion Criteria5

  • Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview
  • Cognitive impairment as evidenced by scores \<22 on the Videoconference-based Mini Mental Status Examination (MMSE; Folstein, et al., 1975)
  • Enrolled in another ongoing evidence-based treatment for PTSD.
  • Pregnancy as verified by pregnancy test
  • No access to cellular service

Interventions

BEHAVIORALProlonged exposure therapy

Twelve weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by therapists trained in prolonged exposure therapy.

BEHAVIORALFinancial incentives

Financial incentives contingent upon completion of prolonged exposure therapy sessions

BEHAVIORALTreatment as usual

Continued standard buprenorphine or methadone maintenance treatment from current treatment provider.


Locations(1)

University of Vemont

Burlington, Vermont, United States

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NCT06288711


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