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临床试验/NCT02946957
NCT02946957Unknown不适用

Efficacy of Scalable CBT for Insomnia in Older Adults With Osteoarthritis Pain

University of Washington2 个研究点 分布在 1 个国家目标入组 327 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
327
试验地点
2
主要终点
Insomnia Severity Index (ISI)

研究概览

简要总结

Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also experience significant sleep disturbance. This randomized trial will determine whether a telephone-based cognitive behavioral treatment targeting insomnia in older adults with chronic severe OA-related insomnia and pain results in substantially greater reductions in insomnia severity and in related improvements in pain, fatigue, mood, quality of life and healthcare costs compared to telephone-delivered education (attention control) about insomnia. The trial will test an intervention that if demonstrated to have long term efficacy is scalable and has the potential for wide-scale deployment in healthcare systems.

详细描述

Twenty-five percent of older adults experience significant osteoarthritis (OA)-related comorbid sleep disturbance. Insomnia is associated with substantial negative effects on function, mood, and medical resource utilization. Cognitive behavioral therapy for insomnia (CBT-I) is evidence based and has been shown to be efficacious in populations with a variety of comorbid conditions including OA-related chronic pain. However, in-person CBT interventions are unlikely to be widely deployable in healthcare systems. Telephone delivery has the advantage of giving patients access to personalized, efficacious CBT-I interventions from home, increasing generalizability, and outreach to minority, rural, and other underserved populations. Older (60+ yrs) primary care patients across Washington State will be screened for severe persistent OA-related insomnia and pain. Two hundred and seventy patients will be randomized to either CBT-I or an education only attention control (EOC). Each treatment will consist of six 20-30 minute telephone-based sessions over an eight week period. Pre-treatment, post-treatment (2 months and 12 month) assessments will include measures of sleep, pain, fatigue, mood, and quality of life. A cost effectiveness evaluation of the intervention will also be conducted. The proposed research will determine if telephone CBT-I improves OA insomnia and associated outcomes in a state-wide primary care population of older adults, and inform policy decisions about widespread dissemination of telephone CBT-I in this and related patient populations.

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

入选标准

  • Age 60+ with one or more health care visits for OA in the prior 3 years
  • Score of ≥6 on 4-item ISI at first screening and ≥11 on full ISI at second screening
  • Score of ≥9 on two items from the Brief Pain Inventory (BPI) asking about average pain intensity in the past 2 weeks (0-10 scale) and activity interference due to pain (0-10 scale) at first and second screening

排除标准

  • Not continuously enrolled at Group Health Cooperative for at least one year
  • Prior diagnosis of a primary sleep disorder: sleep apnea with an AHI/RDI score of 15+ or current use of a CPAP machine; periodic leg movement disorder; restless leg syndrome; sleep-wake cycle disturbance; or rapid eye movement behavior disorder
  • Diagnosis in the medical record of: rheumatoid arthritis, terminal disease, being considered for major surgery, active chemotherapy or radiation for cancer, or inpatient treatment for congestive heart failure within the previous 6 months
  • Diagnosis of dementia, use of acetylcholinesterase inhibitor and/or memantine for cognitive impairment, or cognitive impairment (>6 on the Short Orientation-Memory-Concentration Test)
  • Hearing or speech impairment sufficient to preclude participation in a telephone intervention

结局指标

主要结局

Insomnia Severity Index (ISI)

时间窗: 12 months post baseline

A 7-item questionnaire that is a global measure of perceived insomnia severity. Items use a 5-point scale for total scores of 0-28, with \>15 considered moderate severity.

次要结局

  • Insomnia Severity Index (ISI)(2 months post baseline)
  • Pittsburgh Sleep Quality Index (PSQI)(12 months post baseline)
  • Brief Pain Inventory-short form (BPI-sf)(12 months post baseline)
  • Flinders Fatigue Scale (FFS)(12 months post baseline)
  • Patient Health Questionnaire (PHQ-8)(12 months post baseline)
  • Sleep Hygiene Index (SHI)(12 months post baseline)
  • EuroQoL 5D (EQ-5D)(12 months post baseline)
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC)(12 months post baseline)
  • Use of sleep and pain medications(Baseline through 24 months)
  • Outpatient visits(Baseline through 24 months)
  • Health care costs(Baseline through 24 months)

研究者

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

Michael Vitiello

Professor, Psychiatry and Behavioral Sciences

University of Washington

研究点 (2)

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