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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288711
• Other study ID #: CHRBSS #STUDY00002538
• Secondary ID: R01DA057308
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: November 30, 2027

Study information

• Verified date: May 2024
• Source: University of Vermont
• Contact: Kelly Peck, Ph.D.
• Phone: 8026569610
• Email: Kelly.Peck[@]uvm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: November 30, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Prolonged exposure therapy
Twelve weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by therapists trained in prolonged exposure therapy.
• Financial incentives
Financial incentives contingent upon completion of prolonged exposure therapy sessions
• Treatment as usual
Continued standard buprenorphine or methadone maintenance treatment from current treatment provider.

Locations

Country	Name	City	State
United States	University of Vemont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged exposure therapy session attendance	Percentage of scheduled prolonged exposure therapy sessions attended	From baseline to week 12
Primary	Prolonged exposure therapy completion	Percentage of participants completing eight or more prolonged exposure therapy sessions	From baseline to week 12
Primary	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).	From baseline to week 12
Secondary	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.	From baseline to week 12 and 3, 6 months post-study
Secondary	Change in non-prescribed drug use - self-reported	Time Line Follow Back (TLFB) to measure non-prescribed drug use.	From baseline to week 12 and 3, 6 months post-study
Secondary	Change in opioid craving	Single item measure (range: 0-100) of craving for opioids.	From baseline to week 12
Secondary	Medications for opioid use disorder treatment retention	Percentage of participants retained in medications for opioid use disorder treatment	From baseline to week 12 and 3, 6 months post-study
Secondary	Prolonged exposure therapy acceptability	Treatment Acceptability/Adherence Scale to measure treatment acceptability	From baseline to week 12
Secondary	Satisfaction with prolonged exposure therapy delivered via telemedicine	Telemedicine Satisfaction Questionnaire to measure satisfaction with treatment delivered via telemedicine	From baseline to week 12
Secondary	Prolonged exposure therapy homework adherence	Homework adherence questionnaire to measure prolonged exposure therapy homework adherence	From baseline to week 12
Secondary	Change in posttraumatic stress disorder symptom severity - self-reported	Change in posttraumatic stress disorder symptom severity as measured by PTSD Checklist for DSM-5 (PCL-5) for self-reported posttraumatic stress symptoms. The PCL-5 is a 20-item self-report measure that assesses the 20 symptoms of PTSD. The rating scale is 0-4 for each symptom/item, and overall scores range from 0-80, with lower scores representing better outcomes (less severe PTSD).	From baseline to week 12