Study to Determine the Effectiveness of Therapy Methods (acceptance Commitment Therapy, Micro Breaks) in Patients with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale (FSS)
研究概览
简要总结
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a distinct disease entity with an estimated prevalence of 0.3-0.7% and more common in women (3:1 ratio). It can be diagnosed according to the Institute of Medicine (IOM) 2015 consensus definition using 3 major criteria and one of 2 minor criteria.
Diagnosis requires that the patient have the following three symptoms:
- A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest,
- Post-exertional malaise,* and
- Unrefreshing sleep*
At least one of the two following manifestations is also required:
- Cognitive impairment* or
- Orthostatic intolerance
Note* Frequency and severity of symptoms should be assessed. The diagnosis of ME/CFS should be questioned if patients do not have these symptoms at least half of the time with moderate, substantial, or severe intensity.
Currently, individually tailored therapy with emphasis on cognitive behavioral therapy and graduated activity therapy is considered the therapy of first choice, although their effectiveness has been critically questioned in recent years. There are often frustrating treatment courses, a larger proportion of partial remissions, a significantly smaller proportion of full remissions and return to work.
The study aims to evaluate patients of the outpatient service for chronic fatigue at the Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, Switzerland, in the context of a group therapy for the treatment of CFS/ME in respect to the response to different, non-drug based therapeutic procedures and to gain knowledge about the effects of the therapy.
The study is a clinical comparative study of therapeutic procedures/interventions without the use of drugs or a medical product. The interventions are Acceptance Commitment Therapy (ACT) and Micro Breaks in Everyday Life (MBEL) adapted to CFS/ME. The collection of biological samples (saliva, blood) and health-related personal data (actigraphy, psychometric data from questionnaires) is associated with minimal risks and burdens.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis for CFS/ME
- •Psychiatric clinical stability in the past 3 months:
- •No diagnostic change to other categories of the International Classification of Diseases (ICD-10)
- •No psychiatric inpatient treatments
- •No psychiatric emergency treatments
- •No suicide attempts
- •Possession of internet access
- •Sufficient skills to use electronic devices
- •The willingness to engage in the described therapeutic procedures or interventions (ACT, MBEL)
排除标准
- •Insufficient knowledge of German
- •Severe psychiatric disorders (e.g. personality and posttraumatic stress disorders, dissociative and psychotic disorders, intelligence reduction, untreated attention deficit hyperactivity disorder) and acute suicidal tendencies
- •Untreated or severe internal medicine disorders e.g., thyroid dysfunction, central and obstructive sleep apnea syndrome (i.e., apnea-hypopnea index >15 and/or "high-risk group for obstructive sleep apnea" according to the Berlin Questionnaire)
- •Cardiovascular disease such as chronic heart failure
- •Severe or untreated neurological diseases (e.g. Parkinson's disease, dementia, restless legs syndrome, narcolepsy)
- •Alcohol and drug dependence
- •Initiation of psychopharmacotherapy at a dosage provided for guideline-appropriate treatment of a mental disorder according to the Drug Compendium in the past 3 months
- •Start of other psychotherapy procedures in the last 3 months
- •Other parallel therapy methods (e.g. acupuncture, qigong, osteopathy)
- •Somatic (sleep-disrupting) treatments, cortisone treatment, or radio-/chemotherapy in the last 6 months
研究组 & 干预措施
Acceptance Commitment Therapy for chronic fatigue
ACT for chronic fatigue involves psychoeducation on the clinical picture of CFS/ME and teaching coping strategies for dealing with symptoms, most notably fatigue, postexertional malaise, unrestful sleep, cognitive decline, and orthostatic dysregulation. For this purpose, the therapy manual designed for generalized anxiety disorders is adapted to the needs of patients with CFS, i.e., the exercises and worksheets that teach the acceptance- and mindfulness-based techniques are adapted to the symptoms (fatigue, powerlessness, unrestful sleep, among others). In addition, value goals and scopes of action are defined, in which the individual stress limits of each participant are identified and taken into account. In addition, it is recommended that the participants move within their respective energy limits under the regular evaluation of activity and rest phases using a diary, as well as regularly apply study-specific interventions between the appointments of group therapy.
干预措施: Acceptance Commitment Therapy for chronic fatigue (Behavioral)
Micro breaks in everyday life for chronic fatigue
Micro breaks in everyday life (MBEL) includes restructuring the patients' daily routine in terms of how they organize their breaks. A therapy manual is developed for this purpose, which is divided into three phases. In the first phase, patients learn to allow or integrate regular MB of one to five minutes in their daily routine. Appropriate examples are used to show when and where MB can be incorporated and this is practiced at home over the first few weeks until a routine has been established. Patients are encouraged to keep a break diary. In the second phase, the MBs are filled in with content. MB can be designed differently, e.g., with physical activity of moderate or high intensity, with short breathing or relaxation exercises, with nutrition or even with doing nothing. In the third phase, an individual optimization of the design of breaks in everyday life follows and an expansion towards meaningful mental time-out, a combination of relaxation break and mental activation.
干预措施: Micro breaks in everyday life for chronic fatigue (Behavioral)
Waiting Group
结局指标
主要结局
Fatigue Severity Scale (FSS)
时间窗: The entire duration of the study is 3 years.
The FSS comprises 9 questions, by answering which the patient can assess his limitations due to fatigue of the past week on a 7-point scale. The FSS is considered a well-established assessment tool for surveying subjective fatigue, the resulting limitations in daily, social, as well as occupational life and physical activities. Total score 36-52 is indicative of moderate fatigue ("mild/ no fatigue" at FSS total ≤ 35, "moderate fatigue" at 36 ≤ FSS total ≤ 52), score greater than or equal to 53 is indicative of severe fatigue ("severe fatigue" at FSS total ≥ 53).
次要结局
未报告次要终点
研究者
Sarah Schiebler
Senior Physician, Department of Consultation-Liaison-Psychiatry and Psychosomatic Medicine
University of Zurich