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临床试验/NCT01693978
NCT01693978已完成不适用

Incentivizing Adherence to Prolonged Exposure With Substance Users

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
Prolonged Exposure session attendance

研究概览

简要总结

The aim of this research is to assess whether Contingency Management is effective in improving treatment adherence in substance use disordered (SUD) patients with comorbid PTSD. Although Prolonged Exposure therapy (PE) is the gold standard treatment for PTSD, the few studies of this treatment in substance users have shown poor adherence. Contingency Management is a well-established approach that could be used to enhance adherence to PE. From a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction Treatment Services, an intent-to-treat sample of 62 patients with co-occurring current PTSD will be offered PE. Half of the 62 participants will be randomly assigned to a Prolonged Exposure with Contingency Management (PE+CM) condition that provides monetary-based incentives for attending the PE therapy sessions. The comparison condition will be assigned to a Prolonged Exposure (PE) condition without the attendance incentives intervention. The PE sessions will be scheduled once per week for 12 weeks, with a 12-week follow-up. Groups will be compared primarily on adherence to the PE schedule, improvement in PTSD symptoms, and rates of drug use (urine specimens, self-reported use). The study's three primary aims are to 1) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to increase adherence in SUD patients in a methadone treatment program; 2) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD symptoms in SUD patients; and 3) Evaluate the effect of PE for PTSD on rates of drug use in SUD patients.

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
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •for Phase I (evaluation):
  • •positive screen for PTSD, as determined by score on the MPSS-R
  • •methadone maintenance for at least 4 weeks (to help ensure initial stabilization on methadone)
  • •at least 18 years of age
  • •Inclusion criteria for Phase 2 (treatment):
  • •confirmation of current PTSD based on the Clinician-Administered PTSD Scale
  • •no psychiatric contraindications to PE (e.g., current suicidal/homicidal intent)
  • •clear memory for the traumatic event (e.g., flashbacks or re-experiencing the event)
  • •interest in receiving PE
  • •agree to sign release of information for any current psychiatric treatment providers outside of ATS
  • •agree to delay taking daily methadone dose on exposure therapy days until after session
  • •no history of prior exposure-based therapy for PTSD
  • •agree to audiotaping of therapy sessions

排除标准

  • •pregnancy
  • •acute medical problem that requires immediate and intense medical management (e.g., AIDS defining illness; active tuberculosis)
  • •presence of a formal thought disorder, delusions, hallucinations, or imminent risk of harm to self or others

研究组 & 干预措施

Reinforced Prolonged Exposure (RPE)

Experimental

All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks. RPE participants will receive voucher-based reinforcement contingent on attendance to scheduled Prolonged Exposure therapy sessions.

干预措施: Voucher-Based Reinforcement (Behavioral)

Reinforced Prolonged Exposure (RPE)

Experimental

All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks. RPE participants will receive voucher-based reinforcement contingent on attendance to scheduled Prolonged Exposure therapy sessions.

干预措施: Prolonged Exposure Therapy (Behavioral)

Standard Prolonged Exposure (SPE)

Active Comparator

All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks.

干预措施: Prolonged Exposure Therapy (Behavioral)

结局指标

主要结局

Prolonged Exposure session attendance

时间窗: 12 weeks

PE session attendance will be measured as the percent of participants completing a full course of PE and as a repeating dichotomous variable (weekly assessments of attended vs. unattended sessions).

次要结局

  • Drug use(12 weeks)
  • PTSD symptoms(24 weeks)

研究者

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

Jessica Peirce

Assistant Professor

Johns Hopkins University

研究点 (1)

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