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RecruitingNAINTERVENTIONAL

RCT of Mind-body in Long COVID and Myalgic Encephalomyelitis

We are conducting a study to see if a mind-body approach called the Dynamic Neural Retraining System (DNRS) can help people living with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) or Long COVID. Both are serious conditions that affect many parts of the body. This treatment focuses on the connection between your brain, mind, and body to improve health and your sense of well-being. We want to find out if DNRS can improve symptoms like tiredness, pain, and how you feel generally. We'll be looking at things you tell us, like your quality of life, and also physical measurements like sleep and heart rate. Our goal is to see if this program is truly effective for these complex conditions.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of Alberta
Enrolment target
200
Start
10 Jul 2025
Estimated completion
01 Mar 2028

What is this study about?

This research study is about understanding how a specific mind-body program, called the Dynamic Neural Retraining System (DNRS), might help people who have Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) or Long COVID. Both of these conditions can cause a lot of tiredness, pain, and other difficult symptoms, affecting many different systems in the body, like your nervous system, immune system, and metabolism. We know these are real, challenging illnesses that have a big impact on people's lives.

The idea behind mind-body treatments like DNRS is that your brain, mind, body, and behaviour are all connected and can influence each other. These techniques aim to help you become more aware of these connections and use your brain's natural ability to change (sometimes called 'neuroplasticity') to improve your health. By focusing on certain thoughts, feelings, or actions, we hope to support positive changes in how your body functions. Mind-body approaches might work by affecting how your brain and body communicate using various chemicals, which could be helpful for conditions like ME/CFS and Long COVID where these systems are often out of balance.

Currently, there isn't strong scientific proof that DNRS works, so this study is designed to explore that question carefully. We will compare people using DNRS with those who are on a waiting list for treatment, using different methods to measure any changes. This includes what people tell us about their symptoms and quality of life, as well as objective measures like daily activity and sleep. We will also be looking at changes in body chemistry and gut bacteria to get a more complete picture of how the program might affect your body.

Key takeaways

  • This study explores a mind-body program (DNRS) for ME/CFS and Long COVID.
  • It aims to see if DNRS can improve symptoms like tiredness, pain, and quality of life.
  • Both patient reports and physical measurements will be used.
  • The study helps us understand the brain-body connection in these conditions.
  • Participation involves various assessments and potentially blood/stool samples.
  • You can withdraw from the study at any time.

Who may be eligible?

To take part in this study, you need to be at least 18 years old and have been diagnosed with ME/CFS for more than six months. We welcome people with ME/CFS, whether they also have Long COVID or not.

There are some reasons why you might not be able to join. For example, if you are currently too unwell to participate, don't have reliable internet access, or can't communicate in English, then this study might not be suitable. Also, if you have certain other health conditions that could explain your fatigue (like untreated thyroid problems, diabetes, or severe anaemia), or if you've recently used antibiotics, you might not be eligible. This helps us make sure we are studying the specific effects of the treatment on ME/CFS and Long COVID.

Finally, if you are already involved in another research study or are currently using another mind-body therapy (like yoga, meditation, or similar programs), or plan to start any new treatments during the study period, you wouldn't be able to participate. This is to ensure that any changes we see are likely due to the DNRS program itself.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with ME/CFS for at least six months?
  3. Do you have reliable internet access and can you communicate in English?
  4. Are you NOT currently taking part in another research study or using similar mind-body therapies?
  5. Do you NOT have serious uncontrolled health conditions that could explain your fatigue, or have you used antibiotics recently?
  6. Are you able to provide blood and stool samples if required?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be part of a group that either starts the DNRS program right away or is placed on a waiting list to receive it later. The study will involve a combination of patient-reported outcomes, where you'll tell us about your health and symptoms, and some objective measurements. These objective measurements might include tracking your daily steps, heart rate variability (which shows how your heart responds to different stresses), and sleep patterns. We will also ask for blood samples to look at changes in your body chemistry and stool samples to understand your gut bacteria. There will also be an opportunity for some participants to share their experiences in an interview, to help us understand the study from a personal point of view. The total duration of your participation will be explained in detail if you are invited to join, including any follow-up appointments.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the DNRS program might help improve your symptoms and overall well-being, though we cannot guarantee any specific results. You will also contribute to understanding more about ME/CFS and Long COVID. Potential risks are generally low; DNRS is a mind-body technique, not a medication with side effects, but it may require time and effort. As with any study, you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (3)

  • Peter Lougheed Hospital
    Verified postcode
    Calgary, Canada· Recruiting
  • University of Alberta Hospital/Kaye Edmonton Clinic
    Verified postcode
    Edmonton, Canada· Recruiting
  • Women's College Hospital
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is ME/CFS?

ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) is a long-term illness causing extreme tiredness that doesn't improve with rest, as well as pain, sleep problems, and other symptoms that affect many body systems.

What is Long COVID?

Long COVID refers to symptoms that continue for weeks or months after a COVID-19 infection. These can include tiredness, breathlessness, brain fog, and other issues.

What is Dynamic Neural Retraining System (DNRS)?

DNRS is a mind-body program that aims to help people with ongoing health problems by using mental exercises to retrain brain pathways involved in their symptoms.

How long will the study last if I take part?

The exact length of your participation, including follow-up, will be clearly explained to you before you agree to join. It varies depending on whether you are in the immediate treatment or wait-list group.

Will I get paid to take part?

Information about any payment or reimbursement for your time and expenses will be provided in the detailed study information materials.

How to find out more

MILES RCT team

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "RCT of Mind-body in Long COVID and Myalgic Encephalomyelitis…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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