CClinicalTrials.gg
RecruitingNCT06933173MILESUpdated Sep 9, 2026

RCT of Mind-body in Long COVID and Myalgic Encephalomyelitis

An interventional study of Dynamic neural retraining system in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, sponsored by University of Alberta. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by University of Alberta · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Keywords

  • Myalgic encephalomyelitis/Chronic fatigue syndrome
  • Mind-body intervention
  • Long COVID
  • RCT
  • Patient engagement
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    DNRS intervention group

    Other: Dynamic neural retraining system

  • No intervention
    Wait-list control group

    The waitlist control group will complete the experimental intervention after 4 months. During the waiting period, they will continue to receive usual care and will be asked to not participate in any other new treatments.

Interventions

  • OtherDynamic 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.

05

What researchers measure

Primary outcomes

  1. Physical functioning

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

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

06

Study locations

2 of 2 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06933173
Lead sponsor
University of Alberta
Collaborators
College of Physicians and Surgeons of Alberta
Responsible party
Sponsor
First posted
Apr 18, 2025
Start date
Jul 10, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

MILES RCT team
Contact
rctmiles@ualberta.ca
780-680-8907
Sunita Vohra, MD MSc FRCPC FCAHS
principal investigator · University of Alberta
Eleanor Stein, MD FRCPC
principal investigator · University of Calgary

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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