Development of a Behavioral Intervention for Chronic Pain in Individuals With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants
研究概览
简要总结
Due to its specific pathophysiology and impact on health outcomes, the Institute of Medicine has described chronic pain as a complex chronic disease and a "national public health crisis." The unique neurobiological basis and psychosocial context of chronic pain in HIV-infected patients underscores the importance of developing and testing a behavioral intervention specifically tailored to this population. This study will pilot test a newly-developed behavioral intervention for chronic pain tailored to individuals with HIV.
详细描述
Chronic pain is a chronic condition with a unique neurobiologic basis, which has a substantial impact on physical and emotional function. Chronic pain in HIV-infected patients is common, and associated with serious health consequences, including up to 10 times greater odds of impaired physical function. Many pharmacologic therapies, including opioids, often do not lead to improved pain and function, and carry significant risk. Evidence-based behavioral interventions are among the most effective and safe non-pharmacologic chronic pain treatments investigated in the general medical population. Therefore, behavioral interventions to improve pain, physical, and emotional function in HIV-infected patients are needed. There is much to be learned from existing interventions. However, the success of a behavioral intervention is heavily influenced by how well it is tailored to the target population's biological, psychological, and social environment. Therefore, in this study investigators will conduct a two-arm pilot randomized controlled trial of a recently-developed behavioral intervention compared to routine HIV and pain care, to determine feasibility, acceptability, and preliminary impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Enrolled in the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort
- •Age ≥ 18 years
- •Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate pain for at least 3 months)
- •Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all three times is 4 or greater)
排除标准
- •Do not speak or understand English
- •Are planning a new pain treatment like surgery
- •Cannot attend the group sessions.
研究组 & 干预措施
Intervention
The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain. The participants will complete an outcome assessment within 30 days of the last group session.
干预措施: Intervention (Behavioral)
Control
The control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group. The participants will complete an outcome assessment within 30 days of the last group session.
干预措施: Control (Behavioral)
结局指标
主要结局
Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants
时间窗: From baseline throughout the entire 16 week intervention period
Participants are expected to attend 6 one-on-one sessions and 6 group sessions. Maximum sessions if all attended per participant would be 12 sessions.
次要结局
- Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month(From the conclusion of the intervention through 30 days (Intervention Group). From the last group session through 30 days (Control Group).)
研究者
Jessica Merlin
MD, MBA
University of Pittsburgh