Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 367
- 试验地点
- 4
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
This study compares the efficacy of three group interventions for people with co-morbid osteoarthritis (OA) and insomnia to help them manage their OA symptoms. The investigators hypothesize that a combination cognitive-behavioral treatment will produce significantly greater initial and long-term improvements in OA symptoms than will the other two treatments.
详细描述
This study is only for members of the Group Health Cooperative (GHC) of Puget Sound who have both osteoarthritis pain and insomnia. The first part of the study involves filling out a mailed survey. Based on the results of the survey some respondents will be eligible for the second part of the study. Our goal in the second part is to test three different treatments for managing OA symptoms. The programs teach about things people with arthritis can do to improve the quality of their lives. All three programs deal with pain, sleep, mood and activity-but each has a slightly different focus. Participants will be randomly assigned to one of the three programs. Each program is made up of six weekly group sessions that last about 90-120 minutes. The programs will be co-led by licensed therapists and each will include 8-12 members. Study participants will also take part in a series of visits at their homes over the next 18 months. At each visit the investigators will ask them to do a few other study activities, such as keep a 7-day diary of their sleep and fill out a survey about their arthritis pain. With their permission the investigators will also ask them to let us collect some information from their GHC medical records.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continuously enrolled in Group Health one year prior to sample pull
- •Primary care clinic at selected clinics
- •Not in "No Contact File"
- •Diagnosis 715xx (Osteoarthritis) in prior three years
排除标准
- •Not continuously enrolled in Group Health for at least one year
- •Medical record information indicates a diagnosis of:
- •rheumatoid arthritis
- •obstructive sleep apnea
- •periodic leg movement disorder
- •restless leg syndrome
- •sleep-wake cycle disturbance
- •rapid eye movement (REM) behavior disorder
- •dementia or receiving cholinesterase inhibitors
- •Parkinson's disease or other neurodegenerative disease known to directly impact sleep
- •cancer in the past year and receiving chemotherapy or radiation therapy in the past year
- •inpatient treatment for congestive heart failure within the previous 6 months
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: 18 months post baseline assessment
A 7-item self-report screening measure that rates severity of sleep problems, interference with daily functioning, and participant distress over symptoms. Rated on a scale from 0 (no problems) to 4 (very much a problem).
Global Pain Severity-Graded Chronic Pain Scale
时间窗: 9 months post baseline assessment
The Global Pain Severity Scale derived from the Graded Chronic Pain Scale consists of three 0-10 pain intensity ratings (pain right now, average pain, and worst pain in the prior month) and three 0-10 pain interference ratings (interference with daily activities, recreational, social and family activites, and ability to work including housework).
Global Pain Severity- Graded Chronic Pain Scale
时间窗: 18 months post baseline assessment
The Global Pain Severity Scale derived from the Graded Chronic Pain Scale consists of three 0-10 pain intensity ratings (pain right now, average pain, and worst pain in the prior month) and three 0-10 pain interference ratings (interference with daily activities, recreational, social and family activites, and ability to work including housework).
次要结局
未报告次要终点
研究者
Michael Vitiello
Professor
University of Washington