Actively Recruiting
Study to Determine the Effectiveness of Therapy Methods (Acceptance Commitment Therapy, Micro Breaks) in Patients with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
Led by Sarah Schiebler · Updated on 2024-12-16
90
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
S
Sarah Schiebler
Lead Sponsor
U
University of Zurich
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a condition characterized by profound fatigue, post-exertional malaise, unrefreshing sleep, and cognitive or orthostatic symptoms. It affects about 0.3-0.7% of the population and is more common in women. This study evaluates two non-drug therapies, Acceptance Commitment Therapy (ACT) and Micro Breaks in Everyday Life (MBEL), to understand their effects on CFS/ME symptoms and patient response in an outpatient setting at the University Hospital Zurich. The study compares ACT, which focuses on psychoeducation and mindfulness-based coping strategies adapted for CFS/ME symptoms, with MBEL, which restructures daily routines by integrating short, regular breaks that may include physical activity, relaxation, or mental pauses. A waiting group with no intervention is also included. Each therapy involves manuals tailored to the participants' needs and encourages diary use to track activity and breaks. These behavioral interventions are studied over a three-year period. Participants undergo assessments including the Fatigue Severity Scale (FSS) to measure fatigue levels throughout the study. Biological samples like saliva and blood, along with actigraphy and questionnaires, will be collected to gain insights into therapy effects. The study involves regular evaluations of symptoms, therapy adherence, and personal data related to health and activity. Safety and minimal risk are maintained during sample collection and data gathering.
CONDITIONS
Brief Title
Effectiveness of Acceptance Commitment Therapy or Micro Breaks in Patients with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)
- Psychiatric clinical stability in the past 3 months with no diagnostic changes
- No psychiatric inpatient or emergency treatments in the past 3 months
- No suicide attempts
- Access to the internet and sufficient skills to use electronic devices
- Willingness to engage in Acceptance Commitment Therapy or Micro Breaks interventions
- Age between 18 and 55 years
You will not qualify if you...
- Insufficient knowledge of German
- Severe psychiatric disorders or acute suicidal tendencies
- Untreated or severe internal medical disorders such as thyroid dysfunction or sleep apnea
- Cardiovascular diseases like chronic heart failure
- Severe or untreated neurological diseases (e.g., Parkinson's, dementia)
- Alcohol or drug dependence
- Recent start (past 3 months) of psychopharmacotherapy or other psychotherapy
- Use of other therapy methods like acupuncture, qigong, osteopathy
- Somatic treatments, cortisone, or radio-/chemotherapy in the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive either Acceptance Commitment Therapy, which involves psychoeducation and coping strategies for managing symptoms of chronic fatigue syndrome, or engage in Micro Breaks in everyday life to incorporate short rest periods into their daily routine.
Regular visits throughout the treatment period
Trial Site Locations
Total: 1 location
1
University Hospital of Zurich
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
S
Sarah Schiebler, MBA, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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