Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000086460
Ethics application status
Approved
Date submitted
8/12/2024
Date registered
28/01/2025
Date last updated
28/01/2025
Date data sharing statement initially provided
28/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The investigation of effectiveness of mindfulness meditation on sleep quality in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
Scientific title
The investigation of effectiveness of mindfulness meditation on sleep quality in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
Secondary ID [1] 310666 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Fatigue Syndrome 331833 0
Myalgic encephalomyelitis 336142 0
Poor sleeping quality 336143 0
Condition category
Condition code
Other 328571 328571 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A meditation voice recording will be developed specifically for this study.
Participants will practice mindfulness meditation 10 minutes a day, 7 days a week for eight weeks. Participants are required to practice mindfulness meditation every day at the same time to ensure consistency following a voice recording instruction presented via a website and record their practices in a journal. If participants cannot make it consistent every day, they can report any deviations to the planned schedule. The mindfulness meditation includes breath work, body scan, visualization, and positive affirmation.
Researcher will check in with the participant individually via phone on weekly basis to assist with any difficulties while doing intervention by themselves at home or answer any questions participants might have.
Intervention code [1] 327242 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336379 0
To examine sleep quality changes during an 8-week guided mindfulness meditation.
Timepoint [1] 336379 0
Pre-intervention: within 1-2 weeks before intervention (base line) Post-intervention: within 1-2 weeks after intervention
Primary outcome [2] 340218 0
Examine changes in connectivity within brain regions related to parasympathetic response before and after intervention.
Timepoint [2] 340218 0
Pre-intervention: within 1-2 weeks before intervention (base line) Post-intervention: within 1-2 weeks after intervention
Primary outcome [3] 340219 0
Examine changes in grey matter concentration in brain regions associated with sleep before and after intervention.
Timepoint [3] 340219 0
Pre-intervention: within 1-2 weeks before intervention (base line) Post-intervention: within 1-2 weeks after intervention
Secondary outcome [1] 428098 0
Assessing changes in scores on anxiety symptom rating.
Timepoint [1] 428098 0
Pre-intervention: within 1-2 weeks before intervention (base line) Post-intervention: within 1-2 weeks after intervention
Secondary outcome [2] 443365 0
Assessing changes in scores on depression symptom rating.
Timepoint [2] 443365 0
Pre-intervention: within 1-2 weeks before intervention (base line) Post-intervention: within 1-2 weeks after intervention
Secondary outcome [3] 443366 0
Assessing changes in scores on quality of life rating.
Timepoint [3] 443366 0
Pre-intervention: within 1-2 weeks before intervention (base line) Post-intervention: within 1-2 weeks after intervention
Secondary outcome [4] 443367 0
Assessing changes in scores on well-being rating.
Timepoint [4] 443367 0
Pre-intervention: within 1-2 weeks before intervention (base line) Post-intervention: within 1-2 weeks after intervention
Secondary outcome [5] 443368 0
Assessing changes in scores on fatigue rating.
Timepoint [5] 443368 0
Pre-intervention: within 1-2 weeks before intervention (base line) Post-intervention: within 1-2 weeks after intervention
Secondary outcome [6] 443369 0
Assessing changes in scores on pain rating (a composite secondary outcome)
Timepoint [6] 443369 0
Pre-intervention: within 1-2 weeks before intervention (base line) Post-intervention: within 1-2 weeks after intervention
Secondary outcome [7] 443370 0
Assessing changes in heart rate variability
Timepoint [7] 443370 0
Pre-intervention: within 1-2 weeks before intervention (base line) Post-intervention: within 1-2 weeks after intervention
Secondary outcome [8] 443371 0
Assessing safety, feasibility and tolerability of a self-administered mindfulness meditation intervention.
Timepoint [8] 443371 0
During 8 weeks of intervention
Secondary outcome [9] 444268 0
Assessing health-related quality of life in 8 areas.
Timepoint [9] 444268 0
Pre-intervention: within 1-2 weeks before intervention (base line) Post-intervention: within 1-2 weeks after intervention

Eligibility
Key inclusion criteria
• Persons aged 18-65 years.
• Meet ME/CFS definition based on Canadian Concensus Criteria (CCC) and being diagnosed by a medical professional.
• Meditation naive, have little to no prior experience or exposure to meditation practices. Considered beginners or novices in the realm of meditation and may not have any formal training or understanding of meditation techniques.
• Participants must be able to understand Research Project Information Sheet (RPIS) and provide written informed consent on the Participant Informed Consent Form (PICF).
• Proficient in spoken and written English.
• Have access to a computer at home, in a private space to undergo the mindfulness meditation.
• Participants must be available to attend the Thompson Institute (TI) for 2 MRI scans.
• Participants must be able to attend 60-minute guided meditation class weekly either at the TI or on Zoom.
• Participants must be able to undergo MRI, and tolerate the mindfulness meditation therapy. Tolerability to the technique will be assessed by the researcher, which will include a short training of the technique while attending the TI and as an extra check will include a short interview during the 2nd visit to assess how they are responding to the technique.
• Have basic computer skills and are able to learn and follow new instructions to engage in the technique.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• With diagnosed obstructive sleep apnoea (OSA)
• Pregnant
• With severe intellectual or mental impairment preventing them from fully understanding the study to give consent
• With a known neurological disorder
• Who cannot read and communicate in English
• Recruited by a relationship with the supervisory team or where a conflict of interest exists
• With alcohol or substance related disorder
• With BMI >35

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study will utilise longitudinal analyses to understand the sleep improvement before and after intervention.

Data for each group will be explored using descriptive statistics (mean +/- SD). Differences in gender distribution, age, body mass index (BMI) and questionnaire scores will be analysed by means of chi-squared and one-way ANOVA. The relationship between age, fatigue, diurnal sleepiness will be analysed separately for each group, through Pearson correlation. Statistics will be analysed with SPSS 27.0, and P/q values < 0.05 were considered statistically significant.

Cross-sectional and Longitudinal analysis of the MRI data will be performed using appropriate statistical tests (e.g., Regression, ANOVA, GEE, etc.) so as to define the neurological basis for any changes observed in sleep or symptoms measures at the post-intervention and or baseline relationships.

Sample size and power analysis: A clinically meaningful intervention's average standardised target effect size is 0.3 (Rothwell et al., 2018), which corresponds to a small effect. Thus, we calculated that the theoretical sample size of 31 is required to detect an effect size of 0.3 using analysis of variance (ANOVA) with 2 repeated measures, a type I error of 0.05, and a power of 0.95, assuming correlations between repeated measures of 0.5 and nonsphericity correlations of 1 (G*Power 3.19). The practical sample size of 45 was planned by estimating that 70% of participants would complete the study with acceptable MR image quality based on our previous study (Kennedy et al., 2022).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 41579 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 314884 0
University
Name [1] 314884 0
University of the Sunshine Coast
Country [1] 314884 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast
Address
90 Sippy Downs Dr, Sippy Downs QLD 4556
Country
Australia
Secondary sponsor category [1] 316882 0
Government body
Name [1] 316882 0
Australian Government Research Training Program (RTP) International Stipend Scholarship
Address [1] 316882 0
Australia
Country [1] 316882 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313882 0
University of the Sunshine Coast Ethics Committee
Ethics committee address [1] 313882 0
Ethics committee country [1] 313882 0
Australia
Date submitted for ethics approval [1] 313882 0
17/10/2023
Approval date [1] 313882 0
13/11/2023
Ethics approval number [1] 313882 0
A231955

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129658 0
Mrs Thu Andersen
Address 129658 0
Thompson Institute, University of the Sunshine Coast, 12 Innovation Parkway Birtinya QLD 4575
Country 129658 0
Australia
Phone 129658 0
+61 423 260 649
Fax 129658 0
Email 129658 0
[email protected]
Contact person for public queries
Name 129659 0
Thu Andersen
Address 129659 0
Thompson Institute, University of the Sunshine Coast, 12 Innovation Parkway Birtinya QLD 4575
Country 129659 0
Australia
Phone 129659 0
+61 423 260 649
Fax 129659 0
Email 129659 0
[email protected]
Contact person for scientific queries
Name 129660 0
Thu Andersen
Address 129660 0
Thompson Institute, University of the Sunshine Coast, 12 Innovation Parkway Birtinya QLD 4575
Country 129660 0
Australia
Phone 129660 0
+61 423 260 649
Fax 129660 0
Email 129660 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected] Nil Let HRE FR Approval A231955 13Nov23.pdf
Study protocol  [email protected] MM-CFS_Study Protocol_TA_12Dec2024.docx


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.