Status:
RECRUITING
RCT of Mind-body in Long COVID and Myalgic Encephalomyelitis
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
College of Physicians and Surgeons of Alberta
Conditions:
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
We are studying the effect of a mind-body treatment for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) with or without Long COVID (LC). Our team recognizes that ME/CFS and Lon...
Eligibility Criteria
Inclusion
- Age 18 years or older;
- Individuals diagnosed with ME/CFS, according to the Institute of Medicine (2015) criteria, for more than six months.
Exclusion
- Individuals who: 1) are too ill to participate; 2) lack reliable internet; 3) cannot communicate in English; 4) Presently have or ever had inflammatory bowel disease; and/or 5) Have been prescribed or used an oral or systemic (infusion) antibiotic in the past one month-;; 6) are participating in a concurrent study; 7) are participating in a concurrent mind-body intervention during the study period including
- Art Therapy
- Autogenic training
- Biofeedback/neurofeedback
- Breathing exercise
- Cognitive restructuring
- Dynamic Neural Retraining System
- Emotional Freedom Techniques (EFT)
- Eye movement desensitization and reprocessing (EMDR)
- Guided imagery
- Hypnotherapy/self-hypnosis
- Meditation (mindfulness, mantra, guided, transcendental)
- Mindfulness-based cognitive therapy (MBCT)
- Mindfulness-based Stress Reduction (MBSR)
- Music therapy
- Neurolinguistic programming
- Psychological flexibility
- Qigong
- Relaxation therapy (relaxation response, progressive muscle relaxation)
- Tai Chi
- Visualization
- Yoga and/or starting any other new treatment during the study period, including any mind-body therapy, psychotherapy, prescription medication, over-the-counter medication, etc; 8) have any active medical condition (untreated/uncontrolled) that may explain the presence of fatigue including:
- untreated hypothyroidism (including Hashimoto's disease)
- hyperthyroidism
- diabetes mellitus
- iron deficiency anemia
- other treatable anemia
- iron overload syndrome
- adrenal insufficiency
- Cushing's syndrome
- anorexia nervosa
- iatrogenic conditions such as side effects or interactions of medication(s) or supplements
- • Rheumatological disorders:
- rheumatoid arthritis
- lupus
- polymyositis
- polymyalgia rheumatica
- Sjogren's Syndrome
- Ehlers Danlos Syndromes \[Hypermobility type\]
- • Other heritable disorders of connective tissue:
- Marfan syndrome
- Stickler syndrome etc.
- Multiple sclerosis
- Celiac disease
- Note: Patients with celiac disease can present without gastrointestinal symptoms
- • Immune disorders
- such as HIV/AIDS
- • Sleep disorders
- including obstructive sleep apnea
- • Prior illnesses may relapse or may not have completely resolved during treatment.
- Examples are certain malignancies
- leukemia
- infectious diseases such as tuberculosis and chronic hepatitis
- • Active primary psychiatric disorders
- eating disorders
- alcohol
- substance use disorder
Key Trial Info
Start Date :
July 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06933173
Start Date
July 10 2025
End Date
March 1 2027
Last Update
July 16 2025
Active Locations (3)
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1
Peter Lougheed Hospital
Calgary, Alberta, Canada
2
University of Alberta Hospital/Kaye Edmonton Clinic
Edmonton, Alberta, Canada
3
Women's College Hospital
Toronto, Ontario, Canada