Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Adherence (% of sessions attended)
研究概览
简要总结
The purpose of this pilot trial is to determine the feasibility of integrating exercise and psychotherapy that is specifically targeted to reducing and managing pain into residential drug treatment programs. The investigators will evaluate the feasibility (adherence) of integrating 'assisted' rate cycling, voluntary rate cycling and psychotherapy for pain (I-STOP) in participants with an opioid use disorder (OUD) and pain enrolled in residential drug treatment programs. The investigators will also explore the potential effects of 'assisted' rate cycling, voluntary rate cycling and I-STOP on pain, cravings, depression, anxiety, weight and sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old
- •Must be enrolled in a Residential Drug Treatment Program at a collaborating drug treatment center
- •Must be diagnosed with an Opioid Use Disorder (OUD; ICD-10 F11.20) or a Poly-substance Drug Use that includes an opioid component (ICD-10,F19.xx) and self-reported pain or a pain condition describing a non-cancer related chronic pain disorder
- •Must be approved to exercise in the study by the drug treatment center Medical Director, physician or other relevant clinical staff or primary care physician (PCP)
排除标准
- •Any substantive contraindications to exercise
结局指标
主要结局
Adherence (% of sessions attended)
时间窗: through study completion, an average of 8 weeks
Percentage of exercise and psychotherapy sessions attended
次要结局
- Change in weight(baseline/pre-intervention and immediately after the intervention)
- The investigators will evaluate potential changes in drug cravings using self-report visual analog scale (VAS)(baseline/pre-intervention and immediately after the intervention)
- Change in cravings assessed by standardized questionnaire (Desires for Drug Questionnaire)(baseline/pre-intervention and immediately after the intervention)
- Change in pain(baseline/pre-intervention and immediately after the intervention)
- Change in depression(baseline/pre-intervention and immediately after the intervention)
- Change in sleep(baseline/pre-intervention and immediately after the intervention)
- Change in Anxiety(baseline/pre-intervention and immediately after the intervention)
研究者
Nora Nock
Associate Professor
Case Western Reserve University