Study to Determine the Effectiveness of Therapy Methods (acceptance Commitment Therapy, Micro Breaks) in Patients with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Switzerland
University Hospital of Zurich
RECRUITING
Zurich
Contact Information
Primary
Sarah Schiebler, MBA, MD
sarah.schiebler@usz.ch
0041 44 255 52 80
Time Frame
Start Date: 2023-08-08
Estimated Completion Date: 2026-07
Participants
Target number of participants: 90
Treatments
Active_comparator: 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.
Active_comparator: 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.
No_intervention: Waiting Group
Related Therapeutic Areas
Sponsors
Leads: Sarah Schiebler
Collaborators: University of Zurich

This content was sourced from clinicaltrials.gov