A Randomised Controlled Trial of Cognitive Behavioural Therapy Based Self Help for Fatigue in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 4
- 主要终点
- Change from baseline on ratings of the Modified Fatigue Impact Scale at post measure, 3, 6 & 12 months follow up.
研究概览
简要总结
The purpose of this study is to determine if cognitive behavioural therapy (CBT) based self help is effective for the management of symptoms of fatigue in Multiple Sclerosis (MS).
详细描述
Background: Fatigue is a common disabling symptom in patients with Multiple Sclerosis (MS). Cognitive behavioural therapy (CBT) has been shown to be effective in the reduction of fatigue in MS and CBT-based self-help has been shown to be effective as a low intensity intervention for anxiety and depression.
Objectives: To evaluate the effectiveness of a CBT based self-help workbook at reducing perceived impact of fatigue in a clinical sample of MS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •All participants will be aged 18 or over
- •Will have a recognised diagnosis of relapsing remitting or primary progressive relapsing remitting Multiple Sclerosis from a neurologist
- •Cognitively able to give informed consent as deemed by referring clinician in the Fife Rehabilitation Service
- •Willing to consent to randomised control trial
- •Fatigue as a primary symptom
排除标准
- •Patients with severe anxiety or depression (assessed by cut off on HADS)
- •Patients with psychosis or personality disorders (assessed by referring clinician)
- •Patients currently receiving input from psychological services for fatigue management
- •Patients with suicidal ideation or plans (assessed by referring clinician)
- •Patients who are unable to read the workbook or standardised questionnaires due to literacy levels or cognitive abilities will be excluded from the analysis, although if patients have literacy or cognitive problems, referral to a more suitable 1-to-1 type of therapy will be made.
结局指标
主要结局
Change from baseline on ratings of the Modified Fatigue Impact Scale at post measure, 3, 6 & 12 months follow up.
时间窗: 5 time points at 0, 8, 20, 32 & 60 weeks.
The Modified Fatigue Impact Scale (MFIS) consists of 21 items selected from the Fatigue Impact Scale (FIS; Fisk, Ritvo, Ross, Haase, Murray, \& Schlech, 1994), a multidimensional scale developed to assess the perceived impact of fatigue on a variety of daily activities. The items of the MFIS can be combined into three subscales (Physical, Cognitive, and Psychosocial), as well as into a total MFIS score. All items are scaled so that higher scores indicate a greater impact of fatigue on a patient's activities. Measures will be taken at 5 time points to assess change over time.
次要结局
- Change from baseline on the 36-Item Short Form Survey Instrument at post measure, 3, 6 and 12 months follow up.(5 time points at 0, 8, 20, 32 & 60 weeks)
- Change from baseline on the Hospital Anxiety and Depression Scale at post measure, 3, 6 and 12 months follow up.(5 time points at 0, 8, 20, 32 & 60 weeks)
- Change from baseline on the Self-Efficacy for managing chronic Disease 6 Item Scale at post measure, 3, 6 and 12 months follow up.(5 time points at 0, 8, 20, 32 & 60 weeks)