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: 1. 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, 2. Post-exertional malaise,\* and 3. Unrefreshing sleep\* At least one of the two following manifestations is also required: 1. Cognitive impairment\* or 2. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
ACT was originally developed for the treatment of depression and anxiety. Recently, a single study investigated ACT as a therapeutic approach in CFS/ME and showed no negative effects on disease progression. ACT is characterized by acceptance- and mindfulness-based techniques, serves to promote acceptance and the development of new value goals, and can thereby open up new perspectives on life, which would be promising in terms of a reduction of symptom focus that seems to be a crucial effective factor for an improvement in exhaustion states. The intervention involves psychoeducation 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 anxiety disorders is adapted to the needs of patients with CFS, the exercises and worksheets that teach the acceptance- and mindfulness-based techniques are adapted to the symptoms.
In terms of break design in the work context, research in recent years has increasingly focused on so-called "micro breaks" (MB) - mini breaks of one to five minutes in length. Transferred to mini breaks in everyday life (MBEL), there have been found fundamentally positive effects in terms of performance, vitality and well-being, which could also have a positive impact on the clinical picture of CFS/ME. However, practically no research results are yet available with regard to the implementation of MB in everyday life of patients with CFS/ME. The effects of MB, on the other hand, have been tested several times in everyday work settings and showed desirable effects on mood, attention, fatigue, vitality, performance, and well-being.
University Hospital of Zurich
Zurich, Switzerland
RECRUITINGFatigue Severity Scale (FSS)
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).
Time frame: The entire duration of the study is 3 years.
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