Stepped Care for Patients to Optimize Whole Recovery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 204
- 试验地点
- 3
- 主要终点
- Change in pain interference using The Pain, Enjoyment of Life and General Activity (PEG) Scale
研究概览
简要总结
This is a prospective, randomized clinical trial of 204 patients with opioid use disorder (OUD) and chronic pain (CP) to test the effectiveness of treatment as usual compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce pain interference (Aim 1) and decrease illicit opioid use, alcohol use, anxiety, depression, and stress, and improve sleep (Aim 2). Eligible participants will begin medications for opioid use disorder (MOUD) and will be randomized to receive SC-POWR (i.e., cognitive behavioral therapy (CBT), MOUD, and onsite groups for exercise [Wii Fit, Tai Chi] and stress reduction [relaxation training, auricular acupuncture] for 24 weeks. Participants will be followed for another 24 weeks to evaluate durability of treatment response on pain interference illicit opioid use, alcohol use, anxiety, depression, stress, sleep, and retention in MOUD (Aim 3).
详细描述
Participants who meet criteria for CP and OUD (N=204) will be initiated onto MOUD and randomized to 24 weeks of either treatment as usual (TAU) or 24 weeks of SC-POWR. SC-POWR patients will be "stepped up" according to a priori criteria. Patients randomized to SC-POWR will receive a behavioral intervention consisting of 12 Cognitive Behavioral Therapy (CBT) sessions over a 24-week period involving improvements in substance use and pain since baseline. Following 24 weeks of SC-POWR, patients are offered once monthly peer-support groups.
This study receives support from and included in the HEAL Initiative (https://heal.nih.gov/).
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
- 否
入选标准
- •Seeking treatment at APT Foundation
- •Receiving medications for opioid use disorder (MOUD provided by APT)
- •Have high impact chronic pain (>= 3 months duration of pain occurring most days which limits life or work activities and/or leads to inability to work)
- •Meet DSM-5 criteria for moderate to severe OUD
- •In the past 2 months, has an opioid-positive urine test or self-reports opioid use
- •Understand English
- •Able to provide informed consent
排除标准
- •Have pending surgery or invasive pain management procedure
- •Acutely psychotic, suicidal, or homicidal
- •Psychiatric instability (e.g., recent suicide attempt)
- •Have a contraindication to exercise (e.g. complete heart block)
- •Have a pending or planned relocation or pending incarceration
研究组 & 干预措施
Treatment as Usual
Treatment as usual for opioid use disorder
SC-POWR
Treatment as usual for opioid use disorder with the addition of CBT with possible stepped care to exercise and stress reduction
干预措施: SC-POWR (Behavioral)
结局指标
主要结局
Change in pain interference using The Pain, Enjoyment of Life and General Activity (PEG) Scale
时间窗: Baseline, weekly for 24 weeks, weeks 36 and 48
Pain interference is measured using the PEG scale, a 3-item scale with each item scored from 0-10. Total scores are achieved by averaging the 3 items. Total sore range from 0-10. Higher scores indicate more pain and interference.
次要结局
- Change in alcohol use(Baseline, weekly for 24 weeks, weeks 36 and 48)
- Change in Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)(Baseline, weekly for 24 weeks, weeks 36 and 48)
- Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)(Baseline, monthly for 24 weeks, weeks 36 and 48)
- Change in pain intensity assessed using the Brief Pain Inventory (BPI)(Baseline, weekly for 24 weeks, weeks 36 and 48)
- Change in sleep(Baseline, weekly for 24 weeks, weeks 36 and 48)
- Change in stress assessed using the Perceived Stress Scale (PSS)(Baseline, monthly for 24 weeks, weeks 36 and 48)
- Change in composite illicit opioid use(Baseline, weekly for 24 weeks, weeks 36 and 48)