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临床试验/NCT03692611
NCT03692611已完成不适用

Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV

University of Pittsburgh4 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2019年8月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
278
试验地点
4
主要终点
Brief Pain Inventory (BPI) Total Score

研究概览

简要总结

Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.

详细描述

Behavioral interventions for chronic pain among people living with HIV (PLWH) are an understudied area, with great potential to improve pain and function. Chronic pain is an important comorbidity that affects between 30% and 85% of PLWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve virologic suppression. What is not known is how to optimally address chronic pain in this population. Opioids are a commonly used treatment for chronic pain, particularly in PLWH. Opioid prescribing for chronic pain often does not result in substantial improvement in outcomes and contributes to the growing epidemic of opioid addiction and overdose. In contrast, behavioral interventions are among the most effective and safest treatments for chronic pain in the general population. Pain Self-Management (PSM) is a Social Cognitive Theory (SCT)-based behavioral approach that involves pain-related skill acquisition and goal setting. PSM interventions have been promoted by the 2016 Department of Health and Human Services National Pain Strategy (DHHS NPS) as an effective, scalable approach to chronic pain management. Especially given the current opioid crisis, the DHHS NPS underscored the urgent need to develop and test PSM interventions tailored to the unique needs of vulnerable populations, particularly PLWH, that can be implemented and disseminated nationwide. Until an effective and scalable PSM intervention for chronic pain in PLWH is developed, reducing the burden of chronic pain safely and effectively in this population will not be possible. The overall objective of this proposal is to evaluate a novel theory-based PSM intervention, "Skills TO Manage Pain" (STOMP), developed for and tailored to PLWH. The investigators will accomplish the overall objective with the following primary specific aim: 1) Evaluate the efficacy of STOMP, a theory-based intervention tailored to improving chronic pain in PLWH. Given the investigators' rigorous intervention development process and promising pilot trial results, the working hypothesis is that STOMP will decrease pain and improve function in PLWH. Investigators also propose the following secondary aims: 2) Conduct exploratory analyses of the impact of STOMP on HIV outcomes associated with chronic pain (i.e. retention in care, virologic suppression), and 3) Investigate proximal outcomes as potential mediators of STOMP's impact on chronic pain. This approach is innovative because it incorporates novel peer co-led group sessions that were created based on the investigators' formative intervention development work, includes patients with comorbidities (e.g., depressive symptoms, addiction history) common among PLWH but typically excluded from chronic pain studies, and investigates the impact of a chronic pain intervention on disease-specific HIV outcomes in addition to pain and function. The proposed research will be significant because if successful, it will pave the way for future dissemination and implementation studies that have the potential to dramatically change chronic pain treatment for PLWH.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled in CNICS
  • Age ≥ 18 years
  • English-speaking
  • 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 items is 4 or greater)
  • Ability and willingness to attend the group sessions at the date/time specified
  • No plans for major surgery during the study period that would interfere with study procedures.

排除标准

  • Do not speak or understand English
  • Are planning a new pain treatment like surgery
  • Cannot attend the group sessions
  • Had previously participated in the pilot study (STOMP)
  • Unwilling to provide informed consent

研究组 & 干预措施

Skills to Manage Pain (STOMP)

Experimental

The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.

干预措施: Skills TO Manage Pain (STOMP) (Behavioral)

comparison group

Active Comparator

The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.

干预措施: Comparison group (Behavioral)

结局指标

主要结局

Brief Pain Inventory (BPI) Total Score

时间窗: Immediately postintervention and 3-month follow-up (postintervention)

The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.

次要结局

  • The Pain, Enjoyment and General Activity (PEG) Scale(Immediately postintervention and 3-month follow-up (postintervention))
  • The Pain Self-Efficacy Questionnaire (PSEQ)(Immediately postintervention and 3-month follow-up (postintervention))
  • The Patient Health Questionnaire-8 (PHQ-8)(Immediately postintervention and 3-month follow-up (postintervention))
  • The Pain Catastrophizing Scale (PCS)(Immediately postintervention and 3-month follow-up (postintervention))
  • Brief Pain Inventory (BPI) Functional Interference Subscore(Immediately postintervention and 3-month follow-up (postintervention))
  • Brief Pain Inventory (BPI) Pain Severity Subscore(Immediately postintervention and 3-month follow-up (postintervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Merlin

Visiting Associate Professor

University of Pittsburgh

研究点 (4)

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