A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Change in Current Pain Intensity on an 11 point scale
研究概览
简要总结
This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. Half the participants will receive the intervention, and half the participants will receive usual care with education. Intervention subjects are hypothesized to have significantly less pain-related disability versus usual care subjects after 24 weeks.
详细描述
This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. The investigators propose that emotion regulation is the mechanism of change through which PATH-Pain improves pain and pain-related disability (outcomes). This pilot study will provide initial evidence of the: a) feasibility and acceptability of PATH-Pain; b) effects of PATH-Pain on emotion regulation (mechanism of change) and outcomes (pain and pain-related disability); and c) mediating effect of emotion regulation (mechanism of change) on outcomes (pain and pain-related disability). The investigators will randomize 120 older adults (60 years or older) with chronic non-cancer related pain and negative emotions to PATH-Pain vs. Usual Care with Education (UCE). PATH-Pain will be administered by licensed mental health clinicians. Research assessments will be conducted at the Wright Center at study entry (baseline), and at 5, 10 (end of treatment), and 24 weeks.
Additionally, 20 providers of patients will be interviewed for feedback regarding the intervention.
Edits were made in November 2024 to better align with the study protocol regarding timing and measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The co-investigators performing assessments will be blind to the participant's arm.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Current Pain Intensity on an 11 point scale
时间窗: Baseline, 10 weeks
Pain intensity is an 11 item scale with a range of 0-11 with a higher score indicating higher pain.
Change in Pain-related disability (RMDQ)
时间窗: Baseline, 10 weeks
Pain-related disability as measured by the Roland-Morris Disability Questionnaire (RMDQ). This measure has a range of 0-24, with a higher score indicating higher disability.
次要结局
- Change in Emotion Regulation Mediation (ERQ)(Baseline, 10 and 24 weeks)
- Client Satisfaction Questionnaire (CSQ)(24 weeks)
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)(Baseline, 10 and 24 weeks)