Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288711
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-23
Brief Title:
Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 masters- or doctoral-level therapists PE sessions consist of imaginal exposure ie revisiting and recounting traumatic memories and processing the memory ie 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
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 masters- or doctoral-level therapists PE sessions consist of imaginal exposure ie revisiting and recounting traumatic memories and processing the memory ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA057308 | NIH | None | httpsreporternihgovquickSearchR01DA057308 |