Metacognitive Behavioral Therapy Integrated in Sleep Treatment for Comorbid Insomnia in Patients with Persistent Pain: a Randomized Controlled Semi-Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Actigraphy insomnia indicators (SOL, WASO and EMA in minutes)
研究概览
简要总结
Background: The prevalence of comorbid insomnia is 8-10 times higher in patients with chronic pain than in the general population. Insomnia adds a considerable burden as it worsens the quality of life, restoration and repair, mental health and pain symptoms. Since pain and sleep problems are mutually reinforcing, improvements in sleep may have beneficial effects on pain. Unfortunately, the customary use of sleep medication (TAU: treatment-as-usual) often yields short-lived plus side effects. The "Sleep-Well" intervention examines if a group-based intervention program focusing on sleep literacy, sleep restriction, stimulus control and metacognitive therapy modules may perform better than TAU in improving patients' insomnia and sleep quality.
Eligible patients: Investigators target adult patients referred to the University Hospital of North Norway (Tromsø) for a diagnostic evaluation of their pain condition. Patients eligible for the Sleep-Well study are those who satisfy diagnostic criteria for a non-malign pain disorder plus a comorbid insomnia sleep disorder. Patients are not eligible if they use drugs or large doses of morphine (>100 equivalents), are engaged in an insurance case due to their diagnosis, or participate in other ongoing group programs at the hospital.
Aims: This trial uses a randomized semi-crossover design to examine if the Sleep-Well group does better regarding insomnia and sleep quality than the control patients (TAU). The primary outcome measures are reductions in diagnostic criteria for insomnia, self-reported insomnia symptoms, quality of life, and actigraphy-measured insomnia indicators (long sleep onset latency, frequent nightly awakenings and early morning awakening). The secondary outcome measures include a simplified polysomnography measurement of brain activity during sleep to assess if proportions or durations of slow-wave versus light-wave sleep and EEG-based arousal indices improve. In addition, it is examined if the Sleep-Well intervention incurs benefits concerning pain complaints, dysfunctional sleep and pain cognitions, anxiety and depression.
The intervention: The Sleep-Well program schedules group sessions that cover four topics (sleep literacy, behavioural and mental strategies, maintenance and relapse prevention). All sessions are led by two therapists. Those randomized to the active control group (TAU) cross over to the Sleep-Well intervention three months later.
详细描述
Background: Insomnia is 8-10 times more prevalent among patients with chronic pain than in the general population. The disrupted sleep restoration caused by insomnia can be exhausting for the patient as insomnia also impairs pain inhibition. Sleep medications often yield short-lived clinical responses and further introduce risks of "hangover", tolerance, and even addiction. Psychological sleep treatment is thus clearly preferable given sufficient effect.
Cognitive Behavioral Therapy is the recommended first-line treatment of insomnia (CBT-i). Psychological interventions are also recognized in the treatment and follow-up of chronic pain. However, the evidence of psychological treatment of comorbid insomnia in patients with chronic pain is very limited, although some few results are promising .
Insomnia is the most common sleep disorder and involves nocturnal symptoms (e.g. long sleep onset latency, nightly awakenings, and early morning awakening) and daytime problems (e.g. fatigue, mood swings, concentration difficulties, impaired function at work, school, or in social life). Acute insomnia symptoms triggered by adverse life events or acute illnesses are normal, whereas the transition to chronic insomnia is not. Chronic pain is a chronic stressor and may act both as a precipitating and perpetuating factor for insomnia, generating high levels of stress-activating hormones.
Rumination on the causes of pain is frequently observed in chronic pain, often combined with a cognitive inclination towards catastrophizing (i.e., repetitive, intrusive, and difficult-to-ignore thoughts). Meta-cognitions, such as rumination and catastrophizing may perpetuate insomnia by maintaining a high level of sleep-disruptive psychophysiological arousal and loss of deep sleep. Affective and anxiety disorders are other frequent comorbidities of chronic pain, that may further aggravate the effects of rumination and catastrophizing on both sleep and pain.
Meta-Cognitive Therapy (MCT) has well-documented effects on depression and anxiety disorders. Studies of MCT in insomnia are limited, which is unfortunate as it seems to modulate symptoms substantially across multiple health conditions. The advantage of MCT is the focus on how one relates to, evaluates, monitors, or reacts emotionally to internal thoughts rather than their specific content or experienced truth as in CBT. Change in dysfunctional cognitions about sleep is a central element of CBT-i. The strong association between insomnia and sleep-related metacognitions (thought patterns), rather than negative sleep-related cognitions (thought content), suggests that psychological treatment of insomnia should include MCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who, after clinical examination at University hospital of Northern Norway (UNN) fill the criteria for a chronic non-malignant pain diagnosis according to ICD-
- •Satisfy criteria for a comorbid insomnia
- •Both first-time referrals and former referred patients.
排除标准
- •A comorbid drug abuse diagnosis (ICD-10)
- •An ongoing compensation and/or insurance case related to a health issue, illness or treatment
- •Drug treatment using >100 morphine equivalents
- •Participation in other group-based treatments at the UNN Pain Department or the Physical Outpatient Medical Clinic (must be completed before inclusion)
结局指标
主要结局
Actigraphy insomnia indicators (SOL, WASO and EMA in minutes)
时间窗: Baseline and post-test (3 months), plus follow-up at 3 and 12 months.
Actiwatch Spectrum Plus from Phillips Respironics is used to record motion and bright light exposure during sleep. The actigraphy clock is worn on the left arm for 7 days. Outcome variables are Sleep Onset Latency (SOL; duration in minutes from initiation to falling asleep), Wake After Sleep Onset (WASO; duration in minutes of nightly awakenings), and Early Morning Awakening (EMA; duration in minutes from last wakeup to leaving bed).
Sleep diary insomnia indicators (SOL, WASO and EMA in minutes)
时间窗: Between baseline and post-test (3 months): Five repeated measures across five weeks
Subjects complete a sleep diary log for a week following their participation in each sleep intervention module. The weekly sleep log is used to find and adjust the recommended bedtime concerning the participant's sleep restriction schedule. But as a primary outcome, it estimates Sleep Onset Latency (SOL; duration in minutes from initiation to falling asleep), Wake After Sleep Onset (WASO; duration in minutes of nightly awakenings) and Early Morning Awakening (EMA; duration in minutes from last wakeup to leaving bed) as indicators of insomnia.
Actigraphy insomnia indicators (SE %)
时间窗: Baseline and post-test (3 months), plus follow-up at 3 and 12 months.
Actiwatch Spectrum Plus from Phillips Respironics is used to record motion and bright light exposure during sleep. The actigraphy clock is worn on the left arm for 7 days. Outcome variable is Sleep Efficiency (SE; proportion of sleeping time to total time spent in bed). SE% = Duration of time in sleep / Duration of time in bed.
Insomnia diagnosis
时间窗: Baseline and post-test (3 months)
The Duke Structured Diagnostic Interview for Sleep Disorders (Norwegian version translated by National Competence Center of Sleep Medicine in Bergen). is used to determine whether the DSM-5 criteria for insomnia are met. It is also used to make a clinical judgement of whether patients having other sleep issues, such as restless legs or sleep apnea, should be excluded.
Insomnia symptoms
时间窗: Baseline and post-test (3 months), plus follow-up at 3 and 12 months.
The Bergen Insomnia Scale (5 items, item score range 0-7 days) assesses the number of days per week with nighttime sleeping symptoms lasting more than 30 minutes (SOL-sleep onset latency, WASO-wake after sleep onset and EMA-early morning awakening without regaining sleep), and daytime problems (in number of days per week) related to general dissatisfaction and functional problems in school, work or social life. Symptoms that have a duration of \>3 months and occur more than \>3 days a week satisfy the inclusion criteria for insomnia.
次要结局
- Quality of Life (EQ-5Q-5L)(Baseline and post-test (3 months), plus follow-up at 3 and 12 months)
- Pain intensity, interference and locations (BPI)(Baseline and post-test (3 months), plus follow-up at 3 and 12 months)
- Sleep brain activity as measured by a simplified polysomnography device, i.e., a Home Sleep Test (HST)(Baseline and post-test (3 months))
- Tolerance and Acceptance of chronic pain (CPAQ-R)(Baseline and post-test (3 months), plus follow-up at 3 and 12 months)
- Anxiety and depression (HADS)(Baseline and post-test (3 months), plus follow-up at 3 and 12 months)
- Fatigue (Chalder Fatigue Scale)(Baseline and post-test (3 months), plus follow-up at 3 and 12 months)