Effectiveness of Acceptance Commitment Therapy or Micro Breaks in Patients with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis

Official title

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

Overview

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.

Interventions

• Behavioral Acceptance Commitment Therapy for chronic fatigue
  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 f
• Behavioral Micro breaks in everyday life for chronic fatigue
  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

Primary outcome measures

• Fatigue Severity Scale (FSS) [Time frame: The entire duration of the study is 3 years.]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• University Hospital of Zurich — Zurich

Identifiers

NCT: NCT05168124 · 2021-00671

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗