Mind-body program (DNRS) for Long COVID and ME/CFS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial tests the Dynamic Neural Retraining System (DNRS), a structured mind-body program, in adults with ME/CFS with or without Long COVID. Participants who meet the 2015 IOM criteria for ME/CFS are enrolled at three Canadian sites and must have reliable internet access and English proficiency. Participants are randomized to receive the DNRS intervention or a control condition, with outcomes focused on symptom severity, mood, quality of life, and functional status over the study period. The protocol excludes people who are too ill to participate, have certain medical conditions or recent systemic antibiotics, or who are concurrently receiving other mind-body therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older;
* Individuals diagnosed with ME/CFS, according to the Institute of Medicine (2015) criteria, for more than six months.

Exclusion Criteria:

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

Where it's running

• Peter Lougheed Hospital
  Calgary, Alberta, Canada Recruiting
• University of Alberta Hospital/Kaye Edmonton Clinic
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Sunita Vohra, MD MSc FRCPC FCAHS — University of Alberta
• Study coordinator: MILES RCT team
• Email: rctmiles@ualberta.ca
• Phone: 780-680-8907

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.