Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Vermont
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
>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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Prolonged exposure therapy
BehavioralTwelve weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by therapists trained in prolonged exposure therapy.
Financial incentives
BehavioralFinancial incentives contingent upon completion of prolonged exposure therapy sessions
Treatment as usual
BehavioralContinued standard buprenorphine or methadone maintenance treatment from current treatment provider.
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: Treatment as usual (TAU)Active comparator 1 intervention
Group B: Prolonged exposure therapy (PE)Experimental treatment 2 interventions
Group C: Prolonged exposure therapy + attendance contingent financial incentives (PE+)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Prolonged exposure therapy session attendance
Percentage of scheduled prolonged exposure therapy sessions attended
Time frame
From baseline to week 122
Prolonged exposure therapy completion
Percentage of participants completing eight or more prolonged exposure therapy sessions
Time frame
From baseline to week 123
Change in posttraumatic stress disorder symptom severity - clinician rated
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).
Time frame
From baseline to week 12Secondary outcomes
1
Change in non-prescribed drug use - objective
Change in non-prescribed drug use will be measured by the overall percentage of urine drug screens verified to be positive for non-prescribed opioids (e.g., heroin, methadone, buprenorphine, oxycodone, fentanyl) and non-opioid drugs (e.g., cocaine, amphetamines, benzodiazepines) during the treatment period.
Time frame
From baseline to week 12 and 3, 6 months post-study2
Change in non-prescribed drug use - self-reported
Time Line Follow Back (TLFB) to measure non-prescribed drug use.
Time frame
From baseline to week 12 and 3, 6 months post-study3
Change in opioid craving
Single item measure (range: 0-100) of craving for opioids.
Time frame
From baseline to week 124
Medications for opioid use disorder treatment retention
Percentage of participants retained in medications for opioid use disorder treatment
Time frame
From baseline to week 12 and 3, 6 months post-studySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Vermont
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov