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

RecruitingNAAges 18 Years - 55 YearsAllSarah Schiebler
NCT05168124 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Cognit

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
University Hospital of Zurich
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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