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NCT Number: NCT06933173

RCT of Mind-body in Long COVID and Myalgic Encephalomyelitis

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 Long COVID are serious, debilitating, biomedical conditions.

ME/CFS can affect many different parts of the body, such as the nervous system, immune system, and metabolism. It is hypothesized that central sensitization (i.e., when nerves get 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™, or DNRS™.

Mind-body interventions (MBIs) focus on how the brain, mind, body, and behaviour interact to improve health and well-being. These techniques help people become more aware of themselves, take better care of their health, and boost mood, quality of life, and coping skills. MBIs use the brain's ability to change (neuroplasticity) by reinforcing certain thoughts, feelings, or behaviours that support changes in biology and function. MBIs may influence physical health by affecting how the brain and body communicate through chemicals such as hormones and neurotransmitters. Objective fMRI evidence shows that practising MBIs can change brain structure and function. This makes MBIs a potential good fit for people with chronic illnesses like ME/CFS and LC, which involve complex interactions between the brain, immune system, and hormones.

There is no rigorous peer-reviewed evidence that DNRS is effective. Our study will address this question using subjective and objective measurements in a multiple-methods wait-list randomized controlled trial.

The objectives of this study are to: 1) examine the effectiveness of the DNRS program for individuals diagnosed with ME/CFS with and without Long COVID, compared to a treatment-as-usual wait-list control group on a range of patient-reported outcomes including health-related quality of life, fatigue, pain, anxiety and depression and objective measures including daily steps, heart rate variability, and sleep; 2) quantify metabolic changes through untargeted serum metabolomics profiling, 3) determine if metabolomics screening can predict treatment responsiveness to DNRS; and 4) identify the microbial 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 to learn more about their experiences during the trial.

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Key information

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Behavior COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Health Behavior Infections Lung Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Participation Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter Lougheed Hospital, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic neural retraining system

Other

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.

Primary outcomes

Physical functioning

Time frame: Difference in changes from baseline to post intervention/post waiting (within 4 weeks of completing the DNRS program or waiting period)

Physical functioning of health-related quality of life (HRQL) as measured by the Short Form 36-item Health Survey (SF-36) (V1)

Study contacts

Contact information is provided by the study sponsor or research team.

MILES RCT team

CONTACT

[email protected]

780-680-8907

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

College of Physicians and Surgeons of Alberta

Registry information

Official study title

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

Acronym: MILES

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Apr 18, 2025
Registry last updated: May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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