Internet Administered CBT for Insomnia Comorbid With Chronic Pain Compared to Applied Relaxation Techniques - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
Cognitive behavioural therapy (CBT), that is designed to be short, concise and user friendly is compared to applied relaxation techniques as treatment for insomnia comorbid with chronic pain. Both treatments are administered via internet and participants are randomized to ether treatment arm.
详细描述
Internet treatment with therapist support means that measurements are collected through the Internet. Participants are recruited from a specialized pain clinic for chronic pain. All patients with sleep complaints (Insomnia Severity Index > 14) at their first visit through 2016-01-01 to 2017-07-31 are asked for participation via mail. Volunteers sign informed consent and undergo a online screening. If matching the inclusion criteria, they are contacted for a telephone interview. Subjects are assessed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criterion for insomnia disorder, M.I.N.I. (screening for psychiatric comorbidity) and the other inclusion/exclusion criteria. The treatment, that is designed to be short, concise and user friendly as it is meant to be usable as an adjunct treatment to other main interventions for chronic pain. The treatment lasts for five weeks and focuses on the most potent CBT technics for insomnia; sleep restriction and stimulus control.
Randomization is conducted by university staff not otherwise involved in this study. Participants have equal chance to be allocated to ether CBT or applied relaxation techniques (active controls). The relaxation treatment lasts for the same amount of time (five weeks) and is designed to require similar weekly effort. Both groups fill in sleep diaries every week and weekly feedback is provided by master students supervised by clinical psychologists.
The overall hypothesis is that CBT leads to greater symptom reduction (according to the Insomnia Severity Index) compared to applied relaxation techniques.
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 (Participant)
盲法说明
Participants in both the experiment condition and the active control group were told that they received one of two active treatments in a comparative study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insomnia severity index (ISI) score > 14
- •Chronic pain
排除标准
- •Shift worker or employed as a driver, operator of dangerous equipment and such
- •Sleep apnea, restless legs syndrome, narcolepsy, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- •Bipolar disorder, psychotic disorders, ongoing substance abuse
- •Having received CBT for insomnia during the latest year
- •Pregnancy
- •Severe somatic disorder (such as ongoing cancer, severe neurological condition, insufficiently treated cardiac condition)
- •Impaired movement to such a degree that going to bed or getting out of bed requires assistance
- •Not being able read or wright in Swedish
- •Not having an internet-connected computer, cellular phone or tablet
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Change from baseline insomnia severity (ISI) at 6 months
Measures degree of insomnia. Range 0-28 where a higher value indicates worse sleep.
次要结局
- Pain intensity (NRS)(Change from baseline pain intensity (NRS) at 6 months)
- Patient Health Questionnaire (PHQ-9)(Change from baseline health (PHQ-9) at 6 months)
- Pain Disability Index (PDI)(Change from baseline disability (PDI) at 6 months)
- Sleep diary(Daily during treatment (five weeks).)
- The Karolinska Sleepiness Scale (KSS)(Change from baseline sleepiness (KSS) at 5 weeks)
- Generalised Anxiety Disorder 7-item scale (GAD-7)(Change from baseline anxiety (GAD-7) at 6 months)
研究者
Bjorn Gerdle
Professor
Linkoeping University