Incentivizing Adherence to Prolonged Exposure With Substance Users
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)
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)
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)
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
Jessica Peirce
Assistant Professor
Johns Hopkins University
