Characterisation of Pain in Patients With Musculoskeletal Disease: a Prospective, Longitudinal, Observational Study With an Embedded Feasibility Window of Opportunity Sleep Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
研究概览
简要总结
The goal of this clinical trial is to investigate the potential benefits of a digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) platform, Sleepio, in individuals suffering from fibromyalgia, a condition commonly associated with cognitive issues and sleep disorders.
The main questions this study aims to answer are:
- Does the application of Sleepio improve quality of life in individuals with fibromyalgia?
- Does the use of Sleepio improve cognitive function in individuals with fibromyalgia?
- Does the use of Sleepio enhance sleep quality in these same individuals?
- Does the use of Sleepio improve motor function in this group?
Participants will be randomly assigned to either use the Sleepio platform or standardised health advice, including sleep hygiene material. Those assigned to Sleepio will undergo a series of six 20-minute sessions over 10 weeks with a virtual therapist focusing on cognitive and behavioural strategies for improving sleep.
Participants' quality of life, cognitive function, sleep quality, and pain levels will be monitored and evaluated using online assessment tools. Additionally, a subset of participants will undergo further testing via sleep actigraphy and/or neuroimaging with MRI scans.
Researchers will compare the two groups to determine if the use of Sleepio has a positive effect on quality of life, cognitive function, and sleep quality.
详细描述
Fibromyalgia patients commonly experience cognitive issues such as concentration and memory difficulties and sleep disorders. Despite the prevalence of these symptoms, no established treatments currently exist. Traditional in-person Cognitive Behavioural Therapy (CBT), which focuses on modifying unhelpful thoughts and behaviours, is both expensive and challenging to deliver on a broad scale. New digital forms of CBT, specifically for insomnia (CBT-I), have shown promise in improving cognitive symptoms and sleep quality, but their effect on fibromyalgia patients is yet to be explored.
The study will investigate the efficacy of 'Sleepio', an established digital CBT-I (dCBT-I) tool. Sleepio has shown effectiveness in treating insomnia and its cognitive symptoms, offering a promising approach to address similar issues in fibromyalgia. Sleepio's approach involves six 20-minute sessions over 10 weeks with a virtual therapist who employs key cognitive and behavioural strategies to enhance sleep quality.
Participants in this study will be randomised in a 1:1 ratio to either treatment with Sleepio treatment or standard care with standard sleep hygiene advice. The primary outcome is quality of life measured on the Revised Fibromyalgia Impact Questionnaire (FIQR), 12 weeks following randomisation. Secondary outcomes include subjective cognition (British Columbia Cognitive Complaints Inventory, BC-CCI), objective cognitive function (tests of reaction time, working memory, processing speed), quantitative cognitive avoidance testing (QCAT), sleep quality (actigraphy, insomnia severity index (ISI), Pittsburgh Sleep Quality Index (PSQI), pain (NRS), fear of movement (Tampa Scale of Kinesiophobia) and quantitative movement assessment. Assessments will be carried out using online tools.
Additionally, a subset of participants will undergo sleep actigraphy and/or neuroimaging using MRI scans for a more detailed analysis.
Primary Objectives:
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)
盲法说明
Baseline assessment, randomisation and facilitation of the intervention will be performed by members of the research team who will be blinded to group allocation. The investigators analysing the data will be blinded to group allocations.
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
- •Clinical diagnosis of fibromyalgia
- •Concomitant insomnia, frequent waking in the night or early morning waking
- •Self-reported difficulties with concentration or memory
- •Reliable internet access
排除标准
- •Patients with a poor understanding of English.
- •Patients with known neurological or psychiatric conditions (other than depression or anxiety) likely to independently affect the results of pain assessment, for example peripheral diabetic neuropathy in the opinion of the research team
- •Major neuropsychiatric disorder (bipolar disorder, schizophrenia or psychotic spectrum disorders)
- •Cognitive impairment, dementia or neurodegenerative disorder
- •Recent or planned surgery
- •Current or planned night-time shift work
- •Sleep disorders such as sleep apnoea, restless leg syndrome, circadian rhythm disorder, or parasomnia
- •Taking prescribed sleep medications on more than 2 nights in past 2 weeks
- •Currently receiving other psychological therapy for insomnia
- •Pregnant or lactating
研究组 & 干预措施
Sleepio (dCBT-I)
6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online.
Participants will also receive a booklet with general advice for patients with fibromyalgia, including sleep hygiene.
干预措施: Digital Cognitive Behavioural Therapy for Insomnia (Behavioral)
Treatment as usual
Participants will receive a booklet published by Versus Arthritis designed for patients with fibromyalgia with general advice, including sleep hygiene.
结局指标
主要结局
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
时间窗: 12 weeks
The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems. Higher scores indicate more severe symptoms.
次要结局
- Changes in neurotransmitter concentration in the insular(12 weeks)
- Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline(52 weeks)
- Sleep quality(12 weeks)
- Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline(52 weeks)
- Change in Tampa Scale of Kinesiophobia (TSK) from baseline(52 weeks)
- Cost-effectiveness of dCBT-I(24 weeks)
- Changes in brain structure(12 weeks)
- Changes in brain functional connectivity(12 weeks)
- Changes in brain function(12 weeks)