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临床试验/NCT05033418
NCT05033418已完成不适用

Dual Treatment of Chronic Pain and Insomnia Within an Interdisciplinary Pain Rehabilitation Program

Mary Free Bed Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2019年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
2
主要终点
Insomnia severity

研究概览

简要总结

This study is to evaluate a group-based cognitive behavioral therapy for insomnia (CBT-I) intervention delivered in an interdisciplinary pain rehabilitation program (IPRP) compared to usual care.

详细描述

Dual Treatment of Chronic Pain and Insomnia within an Interdisciplinary Pain Rehabilitation Program

The aim of this project is to develop a dual treatment model for chronic pain and insomnia by combining evidence-based approaches for each condition, addressing an important gap in the research on and treatment of chronic pain.

Insomnia is frequently comorbid among patients with chronic pain. Estimates suggest that 50-80% of patients receiving treatment for chronic pain also report significant insomnia. Patients with comorbid insomnia and chronic pain are at higher risk of negative outcomes compared to individuals without insomnia. More specifically, studies have found that higher levels of insomnia are associated with increased difficulty in reducing opioid use, higher pain intensity, greater functional limitations, lower self-efficacy, higher pain catastrophizing, and more depressive symptoms compared to patients with less severe insomnia. Importantly, for patients with clinically significant insomnia symptoms, insomnia often does not improve to a meaningful extent as a result of chronic pain treatment alone. Accordingly, there is a significant need for dual treatment models that address both chronic pain and insomnia.

Cognitive-Behavioral Therapy for Insomnia (CBT-I) CBT-I is viewed as the "gold standard" treatment for clinical insomnia. In this treatment model, insomnia is viewed as originating from varying precipitating events (e.g., illness, life changes, pain symptoms), but maintained through sleep-related behaviors that increase sleep-related arousal, fragment sleep, and condition an association between bed/nighttime and wakefulness. Accordingly, CBT-I uses conditioning principles to decrease pre-sleep arousal and recondition a pattern of rapid, consolidated sleep. The key components of this intervention are sleep restriction therapy (SRT), which limits time in bed initially to the duration of actual sleep per night, and stimulus control (SC), which involves modification of factors that associate bed/nighttime with wakefulness (e.g., time awake in bed, wakeful activities in bed).

Several randomized controlled trials (RCTs) have been conducted to evaluate this treatment among patients with insomnia and a variety of comorbid chronic pain conditions.8 When compared to usual care or a waiting list control group, patients assigned to receive CBT-I have reported significantly better improvements in insomnia symptoms. In addition, results indicate that the effects of CBT-I delivered to patients with chronic pain have been maintained or improved over time.

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
None

入排标准

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

入选标准

  • enrolled in the IPRP
  • has chronic pain
  • Insomnia Severity Index (ISI) score of 8 or greater
  • English-speaking
  • able to provide informed consent
  • 18 years of age or older

排除标准

  • non-English-speaking
  • unable to provide informed consent
  • less than 18 years of age
  • ISI score less than 8
  • not concurrently enrolled in the IPRP

结局指标

主要结局

Insomnia severity

时间窗: pre- and post-CBT-I intervention (group intervention weeks 1 and 4); pre- and post-IPRP intervention (IPRP weeks 0 and 10)

Insomnia Severity Index (ISI), a 7-item self-report measure was administered to assess insomnia symptoms at up to 4 time points: 1) IPRP admission (both groups), 2) IPRP discharge (10 weeks later; both groups); 3) CBT-I intervention week 1 (IPRP+CBT-I group only) and CBT-I intervention week 4 (IPRP+CBT-I group only)

次要结局

  • Pain severity(pre- and post-IPRP intervention (weeks 0 and 10))
  • Depressed mood(pre- and post-IPRP intervention (weeks 0 and 10))
  • Pain interference(pre- and post-IPRP intervention (weeks 0 and 10))

研究者

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

Julia Craner Cooper

Psychologist

Mary Free Bed Rehabilitation Hospital

研究点 (2)

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