Clinical trial NCT06288711: Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD
Official title: Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Posttraumatic Stress Disorder
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-03-01
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Nearly 90% of individuals with opioid use disorder (OUD) report lifetime trauma exposure and 33% meet criteria for posttraumatic stress disorder (PTSD). Patients with co-occurring PTSD and OUD are at significantly greater risk for poor substance use and mental health outcomes vs. those with OUD alone. Although Prolonged Exposure (PE) therapy is a first-line treatment for PTSD, its efficacy is commonly undermined by poor attendance.

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. In this randomized trial, adults with PTSD (N = 135) who are currently maintained on MOUD will be randomly assigned to one of three conditions: (a) Treatment as usual (TAU), (b) Prolonged exposure therapy (PE), or (c) Prolonged exposure therapy + attendance-contingent financial incentives (PE+). Participants randomized to the TAU condition will continue to receive standard MOUD treatment from their current treatment provider and complete remotely-administered assessments of PTSD symptoms, psychosocial functioning and drug use with an evaluator trained in the administration of all study measures and blinded to treatment condition at intake, monthly during the 12-week intervention, and at 3- and 6-months post-study, but will not receive PTSD treatment. In addition to receiving continued MOUD treatment from their current provider and completing assessments as above, participants assigned to PE will also receive telemedicine-delivered PE consisting of 12 weekly, individual sessions with trained master's- or doctoral-level therapists. PE sessions consist of imaginal exposure (i.e., revisiting and recounting traumatic memories) and processing the memory (i.e., discussing thoughts and feelings related to revisiting the memory). Participants also complete homework assignments consisting of repeated listening to a recording of the imaginal exposure and repeated in vivo exposure to safe situations that have previously avoided because of trauma-related distress. Participants assigned to the PE+ condition will receive the procedures noted above for the PE condition plus attendance-contingent financial incentives delivered immediately following completion of telemedicine-delivered PE sessions via a digital payment delivery platform.

Eligibility criteria: Inclusion Criteria:

* \>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 Criteria:

* 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

Primary outcomes:
measure: Prolonged exposure therapy session attendance
timeFrame: From baseline to week 12
measure: Prolonged exposure therapy completion
timeFrame: From baseline to week 12
measure: Change in posttraumatic stress disorder symptom severity - clinician rated
timeFrame: From baseline to week 12
Secondary outcomes:
measure: Change in non-prescribed drug use - objective
timeFrame: From baseline to week 12 and 3, 6 months post-study
measure: Change in non-prescribed drug use - self-reported
timeFrame: From baseline to week 12 and 3, 6 months post-study
measure: Change in opioid craving
timeFrame: From baseline to week 12
measure: Medications for opioid use disorder treatment retention
timeFrame: From baseline to week 12 and 3, 6 months post-study
measure: Prolonged exposure therapy acceptability
timeFrame: From baseline to week 12
measure: Satisfaction with prolonged exposure therapy delivered via telemedicine
timeFrame: From baseline to week 12
measure: Prolonged exposure therapy homework adherence
timeFrame: From baseline to week 12
measure: Change in posttraumatic stress disorder symptom severity - self-reported
timeFrame: From baseline to week 12
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vemont
state: Vermont
Study officials:
References: