Improving Pain and Functioning Using an Integrative Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- PROMIS Pain Interference 6b
研究概览
简要总结
Chronic pain is common in individuals with opioid use disorder (OUD) and the first-line treatment, Medication for OUD (MOUD), does not address the considerable functional impairments associated with chronic pain. Veterans with OUD and chronic pain could benefit from integrated, behavioral treatment for chronic pain and addiction, but VHA MOUD clinics often lack the resources to offer these services. The proposed study will examine the effectiveness of an evidence-based digital chronic pain and addiction treatment that Veterans can do from home, which can provide a flexible option for Veterans to engage in treatment from home and the Veterans Health Administration (VHA) a means to provide care without placing trained clinicians at each facility.
详细描述
The Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) is a 9-week, web-based treatment supplemented with daily digital surveys that inform personalized weekly feedback messages for people with chronic pain and OUD receiving MOUD. IMPACT is an integration of two previously tested technology-based interventions developed in a prior NIH-funded trial. Typically, VHA pain treatment resources are greater than civilian healthcare settings; therefore, the comparator group (enhanced treatment as usual or ETAU) in the current trial is a necessary step to rigorously test IMPACT specifically within Veteran Health Administration (VHA) clinical care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an ICD-11 opioid use disorder (OUD) diagnosis in the VHA electronic health record (EHR)
- •receipt of buprenorphine from outpatient addiction clinic with stable (i.e., unchanged in 2 weeks or since last injection) dose confirmed by the prescribing clinician. Both oral and injectable buprenorphine formulations will be eligible with dose stabilization required to isolate chronic pain from withdrawal-related pain associated with non-therapeutic dose
- •presence of musculoskeletal pain that is bothersome or high-impact per the Graded Pain Scale - Revised
- •access to a web-connected device to complete daily surveys and connect to Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) treatment site
- •ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at least one block
排除标准
- •dementia-related electronic health record (EHR) diagnosis
- •participant-reported vision or hearing impairments that would preclude use of the Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) system
- •legal actions that would make study completion unlikely
- •current or past 12 month engagement in CBT for chronic pain treatment
- •planned surgical intervention for pain
- •physical or mental health conditions that would interfere with ability to meaningful engage in Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) and Medication for OUD (MOUD) treatment (e.g., uncontrolled bipolar disorder, active suicidal ideation, receipt of hospice or end-of-life palliative care)
研究组 & 干预措施
IMPACT
Data from Veteran participants randomized to digital intervention (IMPACT)
干预措施: Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) (Behavioral)
ETAU
Data from Veteran participants randomized to ETAU (no access to IMPACT)
干预措施: Enhanced Treatment as Usual (ETAU) (Behavioral)
结局指标
主要结局
PROMIS Pain Interference 6b
时间窗: 3-months post-randomization
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to less pain interference).
次要结局
- PROMIS Pain Interference 6b(6- and 9-months post randomization)
- Veterans Rand 12-Item Health Survey (VR-12)(3-months post-randomization)
- Activity Measure for Post-Acute Care (AM-PAC)(3-months post-randomization)
- PROMIS Sleep Disturbance 6a and Duration(3-months post randomization)
- Buprenorphine retention(3-months post randomization)
- Buprenorphine adherence(3-months post randomization)
- Non-prescribed opiate use(3-months post randomization)