Digital CBT-I for Patients With Chronic Pain and Insomnia (The Back2Sleep Trial). A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Average pain intensity during the last 7 days
研究概览
简要总结
Chronic pain constitutes an increasing health and social burden. More than 50% of patients with chronic pain report insomnia, and patients with comorbid insomnia often report stronger and widespread pain, compared to those who are sleeping well. Sleep disturbances are often considered a consequence to chronic pain. This means that insomnia is often overlooked or ineffectively managed with hypnotics or advice on sleep hygiene. Therefore, efficacious, easily accessible, and safe alternatives to the current pharmacological treatments for patients with chronic pain and insomnia are needed. Cognitive behavioral therapy for insomnia (CBT-I) is a cost-effective and safe treatment for insomnia and is recommended as first-line treatment. While highly efficacious, the challenge is to deliver CBT-I to those in need. The main barriers of face-to-face delivered CBT-I are availability of trained therapists, costs, as well as physical and geographical constraints.
The primary aim of this randomized controlled clinical superiority trial is to investigate whether digitally-delivered CBT-I has a greater effect on insomnia and pain than digitally-delivered sleep hygiene education in patients with chronic pain and comorbid insomnia.
Secondary objectives are to a) explore whether the pain-relieving effect is mediated by a change in physiological markers of sleep quality, b) whether health care cost and use of medications at 12 months are reduced after digital CBT-I, and c) to explore the effectiveness of digital CBT-I compared with sleep hygiene education on:
- Physiological sleep metrics (recorded with ear EEG in subsample of 60 patients).
- Self-reported sleep quality.
- Quality of life.
- Physical and mental health.
- Thoughts and beliefs about sleep and pain.
详细描述
This study aims to investigate the efficacy of digital CBT-I for improving sleep (i.e. reducing insomnia severity) and reducing pain intensity in patients with chronic pain and comorbid insomnia. To achieve this goal, the investigators will perform a randomized controlled single-blind clinical superiority trial. Participants will be randomized with an allocation 1:1 ratio into a digital CBT-I group and a sleep hygiene education group. Both groups will use the Hvil® app, but the amount of content will be different. Using a data manager not affiliated with the project through the Open Patients data Exploratory Network (OPEN) at Odense University Hospital, the randomization will be implemented in the program REDCap. The data manager will prepare the randomization list in REDCap. The computer algorithm will use permuted-block randomization of 2, 4 and 6 individuals. No stratifications will be applied to the randomization.
After inclusion, participants will receive an unique randomization key to impute in the Hvil® app according to the abovementioned procedure to receive either digital CBT-I or sleep hygiene education for 9 weeks. This Hvil® App platform is used for both treatments to ensure that only the contents is different, but the form of delivery is the same. All patient reported data will be filled in directly to the eCRF via an online questionnaire using REDCap. Statistical analyses will be blinded to treatment allocation.
Sample size estimation:
Minimal clinical important difference for insomnia severity is 5 point. With an estimated SD for change of 2 times the minimal clinical important difference (SD=10) for patients with chronic pain and insomnia, power of 80%, an alpha value of 0.05, a minimum of 63 participants in each group is required.
Minimal clinical important difference for pain intensity is 15% corresponding to a change of 1.0 points in this population. With a SD for change of 2.0 for patients with chronic pain and insomnia, power of 80%, an alpha value of 0.05, a minimum of 63 participants in each group is required.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For a participant to be eligible, all inclusion criteria must be answered "yes":
- •Age ≥ 18 years.
- •Understand and write Danish.
- •Have smartphone access.
- •Pain for 3 months or longer.
- •Pain must be present on 'most days' or 'every day' within the past 3 months (will be checked by the question: 'In the past 3 months, how often did you have pain? - response options: 'never'; 'some days'; 'most days'; 'every day').
- •Pain must limit life or work activities on 'some days', 'most days', or 'every day' within the past 3 months (will be checked by the question: 'In the past 3 months, how often did your pain limit your life or work activities - response options: never, some days, most days, every day
- •Average pain intensity equal to or higher than 4 on a 0-10 Numeric Rating Scale [NRS] in the past 7 days (ranging from 'no pain' to 'worst imaginable pain').
- •Insomnia symptoms (Insomnia Severity Index (ISI) score > 10; moderate insomnia).
排除标准
- •For a participant to be eligible, all exclusion criteria must be answered "no":
- •Pregnancy or lactation (Pregnancy is screened for through self-reporting as no risks regarding pregnancy have been identified for the described study procedures).
- •Does not have daily assess to smartphone/tablet
- •Night shift during the time of the CBT-I treatment.
- •Currently receiving pharmacological treatment for insomnia (e.g. benzodiazepines, hypnotics etc.).
- •Severe psychiatric/somatic illnesses of relevance of their sleep (reported by participant).
- •Diagnosed sleep disorders (e.g., OSA, narcolepsy).
- •Does not have E-boks.
- •Known abuse of alcohol or other substances.
- •Suicide and self-harm thoughts (reported by participant).
- •People judged incapable, by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
- •For the EEG subgroup only (60 patients):
- •Age ≥ 65 years
- •Anatomy of the outer ear making it impossible to do ear EEG monitoring.
- •Ear piercings that are not compatible with ear EEG.
- •Previous stroke or cerebral haemorrhage and any other structural cerebral disease.
- •Teeth grinding (bruxism).
- •Allergic contact dermatitis caused by metals or generally prone to skin irritation.
研究组 & 干预措施
Digital Sleep hygiene education
Sleep hygiene education is the commonly delivered treatment for insomnia in patients with chronic pain. The digital sleep hygiene education treatment in the Hvil® app includes the sleep hygiene education element that entails specific information relating to lifestyle (diet, exercise, substance use) and environmental factors (light, noise, temperature) that may interfere with or promote sound sleep. Sleep hygiene education also includes specific sleep facilitating recommendations, such as avoiding visual access to a clock in the bedroom, regular sleep scheduling, avoiding long daytime naps, and limiting alcohol, caffeine, and nicotine intake. Parallel to engaging with this element, participants are asked to fill in a sleep diary during the intervention's entire course.
干预措施: Digital Sleep hygiene education (Behavioral)
Digital CBT-I
The digital CBT-I intervention in the Hvil® app is designed to be completed over a period of nine weeks (5 weeks with the components described below and 4 weeks with maintenance of new habits), and is based on the current consensus concerning non-pharmacological treatment of insomnia including five treatment components (sleep restriction, stimulus control, deactivation/relaxation training, cognitive therapy, sleep hygiene education). Each treatment component consists of an information module (i.e., content and purpose of the specific component), assessment module (i.e., assessment of the severity of the "problem" addressed by the component), application module (i.e., specific information on different types of exercises the participant should engage in), and evaluation module (i.e., assessment of the treatment gain). Participants are encouraged to complete the information and assessment module in one streak, estimated to last 30-60 minutes.
干预措施: Digital CBT-I (Behavioral)
结局指标
主要结局
Average pain intensity during the last 7 days
时间窗: Difference in change between groups from baseline to 9 weeks
Average pain intensity during last 7 days will be assessed on a 0-10 Numeric Rating Scale (NRS) (ranging from 'no pain to 'worst imaginable pain')
Insomnia severity
时间窗: Difference in change between groups from baseline to 9 weeks.
Insomnia will be assessed with the Insomnia Severity Index (ISI), which is a brief 7 item patient-reported instrument with a score ranging from 0-28 (0=best;28=worst)
次要结局
- Sleep diary(Daily for 7 nights at baseline and after 9 weeks)
- 50% pain intensity responders(Change from baseline to 9 weeks)
- Global Perceived Effect (GPE) for sleep(After 9 weeks)
- 30% pain intensity responders(Change from baseline to 9 weeks)
- Global Perceived Effect (GPE) for pain(After 9 weeks)
- Thoughts about sleep and pain(Baseline, after 4 weeks and after 9 weeks)
- 50% ISI responders(Change from baseline to 9 weeks)
- Physical and Mental Health(Baseline and after 9 weeks)
- Thoughts about sleep(Baseline, after 4 weeks and after 9 weeks)
- Treatment compliance(After 9 weeks)
- The trajectory of ISI severity scores(Baseline, after 4 weeks, after 9 weeks)
- 30% ISI responders(Change from baseline to 9 weeks)
- Weekly pain intensity score trajectory(Weekly from baseline to 9 weeks)
- Health-related quality of life - anxiety/depression(Baseline and after 9 weeks)
- Sleep Quality(Baseline, after 4 weeks and after 9 weeks)
- Health-related quality of life - usual activities(Baseline and after 9 weeks)
- Health-related quality of life - global(Baseline and after 9 weeks)
- Health-related quality of life - mobility(Baseline and after 9 weeks)
- Health-related quality of life - self care(Baseline and after 9 weeks)
- Health-related quality of life - pain/discomfort(Baseline and after 9 weeks)