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

SNT Gatchaman

Senior Member (Voting Rights)
Staff member
https://clinicaltrials.gov/study/NCT06933173

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.
 
This will be conducted by the University of Alabama, which is where Jarred Younger is based, although no individual is listed at the link above.

Edit to add: No, I was wrong, Trish points out below that it is the University of Alberta, not Alabama.
 
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I wonder what a treatment as usual wait list control actually means?
What are they waiting for? What treatment would be usual?
The blurb makes it sound as if the investigators think 'MBI' is plausible. That is likely to have the usual downsides in terms of trial design. At least it sounds as if actimetry is included. But without any sham treatment or other motivational treatment group it will be quite difficult to interpret an increased step count.
 
DNRS is the Dynamic Neural Retraining System, created by someone named Annie Hopper. It has the same kinds of components as many of the others, as far as I know--positive affirmations, breathing/relaxation exercises, visualizations, etc. It's good they're including some objective outcomes.
 
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
 
Outcome measure
Physical functioning

Measure description
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)
HRQL will be highly influenced by bias and the follow up is way too short. This is not a robust trial at all.
 
This will be conducted by the University of Alabama, which is where Jarred Younger is based, although no individual is listed at the link above.
Alberta Canada, not Alabama.

No researchers named.

Control group gets the intervention after 4 months

Outcomes measured after one month.

It's useless. Anyone caught up in mind training can be still pushing through after just a month and crash later.

Should not be allowed.
 
https://cpsa.ca/about-cpsa/awards-recognition/cpsa-healthier-albertan-grant/
Mind-body In Long Covid and Myalgic Encephalomyelitis Study (MILES): A Patient-Centred RCT
Description by the recipient(s): The Mind-body In Long Covid and Myalgic Encephalomyelitis Study (MILES): A Patient-Centred RCT project will investigate the effectiveness of a mind-body intervention for individuals who meet criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) after COVID-19 infection compared to individuals diagnosed with idiopathic ME/CFS. These complex conditions are post-viral syndromes, sharing similar symptoms and pathophysiology including issues with the central nervous system, immune system, cardiovascular function, metabolism and gut microbiome. Central sensitization (CS), which involves hyper-excitement of central neurons, may worsen symptoms of many chronic conditions including ME/CFS due to Long COVID. To find potential solutions, the research team plans to conduct a multiple-methods wait-list controlled randomized control trial to improve patient-reported outcomes such as health-related quality of life, fatigue, pain and cognitive dysfunction. The study will also investigate metabolomic profiles and microbial signatures in these individuals. Our team firmly acknowledges ME/CFS and Long COVID as serious, debilitating, biomedical conditions. Mind body interventions teach consistent, self-directed use of purposeful thoughts, feelings and actions that support changes in biology and function. If successful, this non-pharmacological intervention could significantly enhance patients’ quality of life and provide valuable insights into managing complex chronic conditions.

Albertans impacted: Albertans who have or will have COVID-19 (estimated 15% developing long-COVID) as well as immigrant, racialized and Indigenous communities due to COVID’s disproportionate affect on these groups

Organization(s)/Individual(s): Co-Principal Investigators (PIs): Dr. Sunita Vohra, MD MSc FRCPC FCAHS, Faculty of Medicine & Dentistry, University of Alberta and Dr. Eleanor Stein, MD FRCPC, Cumming School of Medicine, University of Calgary, Qualitative PI: Dr. Douglas Gross, Ph.D., BScPT, Faculty of Rehabilitation Medicine – Physical Therapy, University of Alberta, Wearable Technology PI: Dr. Victor Ezeugwu, PhD., PT, Faculty of Rehabilitation Medicine – Physical Therapy, University of Alberta, Metabolomics PI: Dr. Jane Shearer, PhD, Department of Biochemistry and Molecular Biology, Cumming School of Medicine, University of Calgary and Microbiome PI: Dr. Christina Thornton MD, PhD, FRCPC, Departments of Medicine, Microbiology, Immunology and Infectious Diseases, Cumming School of Medicine, University of Calgary.
 
The website has a list of success stories and endorsements by professors and practitioners:
https://retrainingthebrain.com/

The program costs $350 for one year of access and you can buy additional coaching. It’s $20/month after one year to keep access.

They also have a Global Community Forum for everyone that has purchased the program.
Why would someone need to keep paying a prescription if their brain has been 'retrained'? I guess it's so "plastic" that it has to be constantly remolded in The Right WayTM.

This is a business model seeking to build supporting evidence.

The harsh truth about this pseudoscience is that if promoters truly believed in it, they would use rigorous trials, run by skeptics. But of course that's bad for business, so they never do that. Uri Geller never made the mistake of not using his own spoons after that infamous incident on Jonny Carson, even though it did nothing to harm his reputation.

The "drink my own pee" industry really needs to learn from them.
 
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