RCT of Mind-body in Long COVID and Myalgic Encephalomyelitis

NCT06933173 | Recruiting

• 1 other identifier: Pro00138185
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Keywords

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

Outcome Measures

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)

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

Study Arms (2)

DNRS intervention group

EXPERIMENTAL

Other: Dynamic neural retraining system

Wait-list control group

NO INTERVENTION

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

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.

DNRS intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• College of Physicians and Surgeons of Alberta: collaborator

Study Sites (3)

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

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Post-Acute COVID-19 Syndrome; Patient Participation

Condition Hierarchy (Ancestors)

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

Study Officials

• Sunita Vohra, MD MSc FRCPC FCAHS

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Eleanor Stein, MD FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MILES RCT team

CONTACT

780-680-8907; rctmiles@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 18, 2025
• Study Start: July 10, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

CA (3)