Myalgic Encephalomyelitis/Chronic Fatigue SyndromeMILESNCT06933173
RCT of Mind-body in Long COVID and Myalgic Encephalomyelitis
A study testing Dynamic neural retraining system in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- What is being tested?
- Dynamic neural retraining system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Jul 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Individuals diagnosed with ME/CFS, according to the Institute of Medicine (2015) criteria, for more than six months.
Who cannot join
- 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
Show all 57Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Peter Lougheed Hospital
Calgary, Alberta
Elizabeth MacKay, MD, Elizabeth.Mackay@albertahealthservices.ca
- Recruiting
University of Alberta Hospital/Kaye Edmonton Clinic
Edmonton, Alberta
MILES RCT team, 780-680-8907, rctmiles@ualberta.ca
Sunita Vohra, svohra@ualberta.ca
About this study
Official title: Mind-Body in Long COVID and Myalgic Encephalomyelitis Study (MILES): A Patient-Centred RCT
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.
Read more
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.
- Being tested
- Dynamic neural retraining system
- Keywords
- Myalgic encephalomyelitis/Chronic fatigue syndrome, Mind-body intervention, Long COVID, RCT, Patient engagement
- Medical subject headings
- Fatigue Syndrome, Chronic, Post-Acute COVID-19 Syndrome, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic neural retraining systemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DNRS intervention group | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning
Physical functioning of health-related quality of life (HRQL) as measured by the Short Form 36-item Health Survey (SF-36) (V1)
Measured: Difference in changes from baseline to post intervention/post waiting (within 4 weeks of completing the DNRS program or waiting period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start10 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgic Encephalomyelitis/Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- College of Physicians and Surgeons of Alberta
- Responsible party
- Sponsor
- Investigators
- Sunita Vohra, MD MSc FRCPC FCAHS, Principal investigator, University of AlbertaEleanor Stein, MD FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933173
- Sponsor's protocol ID
- Pro00138185
- Acronym
- MILES
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-Body in Long COVID and Myalgic Encephalomyelitis Study (MILES): A Patient-Centred RCT
- ClinicalTrials.gov ID
- NCT06933173
- Acronym / sponsor ID
- MILES / Pro00138185
- Keywords
- Myalgic encephalomyelitis/Chronic fatigue syndrome, Mind-body intervention, Long COVID, RCT, Patient engagement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- College of Physicians and Surgeons of Alberta
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older;
- Individuals diagnosed with ME/CFS, according to the Institute of Medicine (2015) criteria, for more than six months.
Key exclusion criteria (57 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic neural retraining systemDescription: 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. | Other | DNRS intervention group |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sunita Vohra, MD MSc FRCPC FCAHS principal investigator
University of Alberta
Eleanor Stein, MD FRCPC principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic neural retraining system in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MILES RCT team (780-680-8907, rctmiles@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.