We are studying the effect of a mind-body treatment for people with MyalgicEncephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) with or without Long COVID (LC). Ourteam recognizes that ME/CFS and Long COVID are serious, debilitating, biomedicalconditions.ME/CFS can affect many different parts of the body, such as the nervous system, immunesystem, and metabolism. It is hypothesized that central sensitization (i.e., when nervesget too excited) may influence these complex conditions and may make symptoms worse.This study explores a mind-body program called the Dynamic Neural Retraining System™, orDNRS™.Mind-body interventions (MBIs) focus on how the brain, mind, body, and behaviour interactto improve health and well-being. These techniques help people become more aware ofthemselves, take better care of their health, and boost mood, quality of life, and copingskills. MBIs use the brain's ability to change (neuroplasticity) by reinforcing certainthoughts, feelings, or behaviours that support changes in biology and function. MBIs mayinfluence physical health by affecting how the brain and body communicate throughchemicals such as hormones and neurotransmitters. Objective fMRI evidence shows thatpractising MBIs can change brain structure and function. This makes MBIs a potential goodfit for people with chronic illnesses like ME/CFS and LC, which involve complexinteractions between the brain, immune system, and hormones.There is no rigorous peer-reviewed evidence that DNRS is effective. Our study willaddress this question using subjective and objective measurements in a multiple-methodswait-list randomized controlled trial.The objectives of this study are to: 1) examine the effectiveness of the DNRS program forindividuals diagnosed with ME/CFS with and without Long COVID, compared to atreatment-as-usual wait-list control group on a range of patient-reported outcomesincluding health-related quality of life, fatigue, pain, anxiety and depression andobjective measures including daily steps, heart rate variability, and sleep; 2) quantifymetabolic changes through untargeted serum metabolomics profiling, 3) determine ifmetabolomics screening can predict treatment responsiveness to DNRS; and 4) identify themicrobial signatures of large bowel microbiota in Long COVID patients pre and post MBI.A descriptive qualitative study will also be conducted in a sample of participants tolearn more about their experiences during the trial.
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Other: Dynamic neural retraining system
Description: The DNRS program includes the following components: 1) cognitive-behavioural
therapy; 2) mindfulness-based cognitive restructuring; 3) emotional restructuring
therapy; 4) neural linguistic programming; 5) incremental training; and 6) behaviour
modification therapy. DNRS offered in this study includes a 14-hour online course
followed by a 12-week online "LIVING DNRS" group support program. The 14-hour online
course includes a variety of exercises, instructional videos, and a workbook. Upon
completion, participants are offered a 12-week LIVING DNRS Group Support program which
provides individuals with support in how to best implement DNRS into their daily lives
with the help of a trained facilitator as well as peer support.
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
University of Alberta
Edmonton, Alberta, Canada
Investigator: MILES RCT team
Contact: 780-680-8907
rctmiles@ualberta.ca
MILES RCT team
780-680-8907
rctmiles@ualberta.ca
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