The Efficacy of Cognitive Behavioural Therapy for Insomnia (CBT-I) on Sleep in Patients With Rheumatoid Arthritis: the Randomised, Non-blinded, Parallel-group Sleep-RA Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Polysomnography (PSG): Sleep efficiency.
研究概览
简要总结
Introduction:
Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory joint disease that attacks peripheral joints and posterior tissues. More than half of patients with RA also have insomnia, which can modify pain, fatigue, quality of life and comorbidities. Traditional treatment of insomnia is often based on pharmacological drugs, however cognitive behavioural therapy for insomnia (CBT-i) have shown effect in insomnia with less side effects. It remains to determine whether CBT-i can be effective in patients with RA.
The primary objective of this Sleep-RA trial is to assess the efficacy of CBT-i on sleep efficiency in patients with RA at week seven. Key secondary objectives are to estimate the clinical efficacy of CBT-i on wake after sleep onset, total sleep time, sleep onset latency, insomnia, sleep quality, fatigue, RA impact of disease and depressive symptoms at week 26.
Methods & Analysis:
Sleep-RA will be carried out as a randomised controlled trial (RCT) with randomised assignment and two-group parallel design. Patients with RA and insomnia are randomly allocated 1:1 to the intervention group or the control group. The intervention group will once a week for six weeks receive group-based CBT-i, a multi-component intervention of; sleep education, stimulus control, sleep restriction, cognitive therapy and relaxation. The control group will continue treatment as usual (insomnia will remain untreated). Follow-up assessments will be carried out seven and 26 weeks after baseline. The primary outcome is sleep efficiency measured with polysomnography at week seven. Key secondary outcomes are: wake after sleep onset, total sleep time, sleep onset latency, insomnia, sleep quality, fatigue, RA impact of disease and depressive symptoms from baseline to week 26. Polysomnography, actigraphy and Disease Activity Score 28-Joint Count C reactive protein will be assessed by medical staff blinded to group allocation. The project manager will assist the participants with questionnaires and conduct the intervention of CBT-i and will therefore not be blinded to group allocation. With a sample size of 60 patients the trial will have more than 85 % power to detect a mean difference between groups of 6 % points in the primary outcome of sleep efficiency measured at week seven and a reasonable statistical power to explore the clinical efficacy according to the eight key secondary outcome measures at week 26.
Ethics and dissemination:
Ethics approval has been obtained from The Committee on Health Research Ethics. We plan to submit a manuscript with the content of this protocol, and at least one scientific manuscript on the results of the primary and key secondary outcomes to a peer-reviewed journal. Results will be presented at conferences, community and consumer forums and hospital grand rounds.
详细描述
Introduction:
More than half of patients with rheumatoid arthritis has concomitant insomnia. Insomnia may modify pain, fatigue, quality of life and comorbidities which many patients struggle with. To address this issue, a nurse led sleep outpatient clinic was established in 2015 at the Center for Rheumatology and Spine Diseases in the Capital Region of Denmark. The aim of this clinic is to identify the causes and severity of insomnia in patients with inflammatory joint diseases and to treat it with non-pharmacological initiatives. Eligible patients can be referred to the clinic by rheumatologists and rheumatology nurses. The current project, entitled Sleep-RA, is designed to expand the evidence-based opportunities of non-pharmacological treatment of insomnia within a biopsychosocial perspective among patients with inflammatory joint diseases. First and foremost, we want to assess the efficacy of cognitive behavioural therapy for insomnia on sleep efficiency in patients with rheumatoid arthritis and concomitant insomnia.
Rheumatoid Arthritis:
Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory joint disease (IJD) that affects peripheral joints. The inflammation typically cause tender and swollen joints and cartilage degradation and bone erosions may occur. RA is diagnosed from medical history, physical examination, blood samples and imaging. Prevalence worldwide is 0.4-1.3 % and RA affects women two-three times more frequently than men; onset is most often at 50-60 years of age. The most commonly used method for monitoring disease activity is the Disease Activity Score 28 (DAS28-CRP) based on 28 joint count of tender and swollen joints, C-Reactive Protein (CRP) and 'patient global assessment'. Rheumatological treatment of RA targets reduction of disease activity and is primarily pharmacological with synthetic disease-modifying antirheumatic drugs (csDMARDs), in which methotrexate is the first drug of choice. Biological antirheumatic drugs (bDMARDs) are used in the absence or insufficient effect of csDMARD.
Consequences and symptoms of RA:
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)
盲法说明
Application of PSG equipment prior to monitoring sleep efficiency and subsequent analysis of results will be conducted by neurophysiology assistants at the Danish Center for Sleep Medicine (DCSM) blinded to participants' allocation. Examination of participants' joints related to the secondary outcome of disease activity will be conducted by a project nurse specialized in rheumatology blinded to participants' allocation. Blood samples related to RA and disease activity will be taken and analysed by a medical laboratory technologist blinded to participants' allocation. Patient Reported Outcome Measures (PROMs) will be collected via questionnaires on tablets handed out by the project manager, who will also conduct the intervention of CBT-I, and therefore not able to be blinded to allocation.
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
- •Diagnosed with RA according to American College of Rheumatology/European League Against Rheumatism criteria 2010
- •18 years of age or older
- •Patients with low-to-moderate disease activity (DAS28-CRP ≤ 5.1)
- •Sleep score ≥ 2 (DANBIO)
- •Insomnia severity Index (ISI) ≥ 11
- •Unchanged medical treatment with anti-rheumatics > 3 months
- •No indication for change of medical treatment with anti-rheumatic drugs the next three months
- •Understand and read Danish.
排除标准
- •Glucocorticoid administration (i.m., i.a., i.v.) < four weeks
- •Oral glucocorticoid administration > 5 mg/day
- •Change in oral glucocorticoid dose < three month
- •Prior or current contact with rheumatic sleep outpatient clinic
- •Night work during the intervention
- •Pregnant or breastfeeding
- •Current alcohol or drug use disorder
- •Patient related circumstances (physical or mental) that impede the ability to give informed consent or adhere to the trial programme.
结局指标
主要结局
Polysomnography (PSG): Sleep efficiency.
时间窗: Assessed at week 7.
PSG is a multi-parametric test that is used in the study of sleep and as a diagnostic tool in sleep medicine. PSG is a comprehensive recording of the biophysiological changes that occur in the human body when the person is asleep. In Sleep-RA, 17 electrodes are attached to each participant, monitoring: electroencephalogram (EEG), eye movements electro-oculogram (EOG), electromyogram muscle activity or skeletal muscle activation (EMG), heart rhythm (ECG), respiratory airflow, respiratory effort and peripheral pulse oximetry.
次要结局
- Rheumatoid Arthritis Impact of Disease (RAID): impact of disease.(Assessed at week 26.)
- Polysomnography (PSG): Total sleep time.(Assessed at week 26.)
- Insomnia Severity Index (ISI): Insomnia.(Assessed at week 26.)
- Bristol Rheumatoid Arthritis Fatigue -Multidimensional Questionnaire (BRAF-MDQ): Fatigue.(Assessed at week 26.)
- Pittsburgh Sleep Quality Index (PSQI): Sleep quality.(Assessed at week 26.)
- The Hospital Anxiety and Depression Scale for Depression (HADS-D): Depressive symptoms.(Assessed at week 26.)
- Polysomnography (PSG): Wake after sleep onset.(Assessed at week 26.)
- Polysomnography (PSG): Sleep onset latency.(Assessed at week 26.)
研究者
Bente Appel Esbensen
Researcher Manager, Associate professor
Glostrup University Hospital, Copenhagen