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临床试验/NCT06288711
NCT06288711招募中不适用

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

University of Vermont2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2024年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
135
试验地点
2
主要终点
Prolonged exposure therapy completion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >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.

排除标准

  • 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

研究组 & 干预措施

Prolonged exposure therapy (PE)

Experimental

In addition to receiving standard buprenorphine- or methadone-maintenance treatment from their current provider and completing scheduled assessments as described above, PE participants will also receive 12 individual sessions of prolonged exposure therapy scheduled weekly over the 12-week treatment period and delivered via a secure and university-supported telemedicine platform. Beginning in study week 1, PE participants will complete weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by doctoral or master's level therapists trained in prolonged exposure therapy.

干预措施: Prolonged exposure therapy (Behavioral)

Prolonged exposure therapy + attendance contingent financial incentives (PE+)

Experimental

Participants assigned to the PE+ condition will receive the procedures noted above for the PE group plus financial incentives delivered contingent upon completion of PE sessions.

干预措施: Prolonged exposure therapy (Behavioral)

Prolonged exposure therapy + attendance contingent financial incentives (PE+)

Experimental

Participants assigned to the PE+ condition will receive the procedures noted above for the PE group plus financial incentives delivered contingent upon completion of PE sessions.

干预措施: Financial incentives (Behavioral)

Treatment as usual (TAU)

Active Comparator

Participants randomized to TAU will continue to receive standard buprenorphine or methadone maintenance treatment from their current treatment provider and complete follow-up assessments as described above. However, they will not receive posttraumatic stress disorder treatment. Staff will mail participants an emergency naloxone kit containing two naloxone doses with simple instructions, a list of resources and contact information for mental health providers and other relevant resources in their community and assistance contacting any resources of interest.

干预措施: Treatment as usual (Behavioral)

Prolonged exposure therapy (PE)

Experimental

In addition to receiving standard buprenorphine- or methadone-maintenance treatment from their current provider and completing scheduled assessments as described above, PE participants will also receive 12 individual sessions of prolonged exposure therapy scheduled weekly over the 12-week treatment period and delivered via a secure and university-supported telemedicine platform. Beginning in study week 1, PE participants will complete weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by doctoral or master's level therapists trained in prolonged exposure therapy.

干预措施: Treatment as usual (Behavioral)

Prolonged exposure therapy + attendance contingent financial incentives (PE+)

Experimental

Participants assigned to the PE+ condition will receive the procedures noted above for the PE group plus financial incentives delivered contingent upon completion of PE sessions.

干预措施: Treatment as usual (Behavioral)

结局指标

主要结局

Prolonged exposure therapy completion

时间窗: From baseline to week 12

Percentage of participants completing eight or more prolonged exposure therapy sessions

Prolonged exposure therapy session attendance

时间窗: From baseline to week 12

Percentage of scheduled prolonged exposure therapy sessions attended

Change in posttraumatic stress disorder symptom severity - clinician rated

时间窗: From baseline to week 12

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).

次要结局

  • Change in non-prescribed drug use - self-reported(From baseline to week 12 and 3, 6 months post-study)
  • Prolonged exposure therapy acceptability(From baseline to week 12)
  • Prolonged exposure therapy homework adherence(From baseline to week 12)
  • Change in opioid craving(From baseline to week 12)
  • Satisfaction with prolonged exposure therapy delivered via telemedicine(From baseline to week 12)
  • Change in non-prescribed drug use - objective(From baseline to week 12 and 3, 6 months post-study)
  • Medications for opioid use disorder treatment retention(From baseline to week 12 and 3, 6 months post-study)
  • Change in posttraumatic stress disorder symptom severity - self-reported(From baseline to week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelly Peck

Assistant Professor

University of Vermont

研究点 (2)

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