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

Mind-Body in Long COVID and Myalgic Encephalomyelitis Study (MILES): A Patient-Centred RCT

We will try the Dynamic Neural Retraining System (DNRS), a mind-body program, in adults with ME/CFS, including those who also have Long COVID.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Alberta (other)
• Locations: 3 sites (Calgary, Alberta and 2 other locations)
• Trial ID: NCT06933173 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older who have had ME/CFS for more than six months per the 2015 IOM criteria, can communicate in English, have reliable internet, and are well enough to participate are ideal candidates.

Not a fit: People who are too ill to take part, those with a history of inflammatory bowel disease, recent systemic or oral antibiotics, lack reliable internet or English proficiency, or who are currently in other mind-body programs or concurrent studies may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the DNRS program could reduce symptom burden and improve quality of life and coping for people with ME/CFS and Long COVID.

How similar studies have performed: Mind-body interventions have shown mixed but sometimes modest benefits for fatigue and quality of life in related conditions, while rigorous trial evidence specifically for DNRS is limited.

Eligibility criteria

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 this trial is running

Calgary, Alberta and 2 other locations

• Peter Lougheed Hospital — Calgary, Alberta, Canada (RECRUITING)
• University of Alberta Hospital/Kaye Edmonton Clinic — Edmonton, Alberta, Canada (RECRUITING)
• Women's College Hospital — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Sunita Vohra, MD MSc FRCPC FCAHS — University of Alberta
• Study coordinator: MILES RCT team

Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Myalgic encephalomyelitis/Chronic fatigue syndrome, Mind-body intervention, Long COVID, RCT, Patient engagement