RCT of Mind-body in Long COVID and Myalgic Encephalomyelitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older;
Individuals diagnosed with ME/CFS, according to the Institute of Medicine (2015) criteria, for more than six months.
Disqualifiers
Art Therapy
Autogenic training
Biofeedback/neurofeedback
Breathing exercise
Trial design
Design model
Crossover
Treatments tested in this trial
Dynamic neural retraining system
Other interventionDescription: 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: DNRS intervention groupExperimental treatment 1 intervention
Group B: Wait-list control groupNo intervention 0 interventions
Trial outcomes
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
College of Physicians and Surgeons of Alberta
Collaborator
Source ClinicalTrials.gov