Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000376549p
Ethics application status
Submitted, not yet approved
Date submitted
1/03/2024
Date registered
2/04/2024
Date last updated
2/04/2024
Date data sharing statement initially provided
2/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study on the efficacy of Mindfulness-Based Stress Reduction (MBSR) for improving mental health and metabolic profile among diabetes patients living in regional and rural north Queensland: A randomized clinical trial
Scientific title
A pilot study on the efficacy of Mindfulness-Based Stress Reduction (MBSR) for improving mental health and metabolic profile among diabetes patients living in regional and rural north Queensland: A randomized clinical trial
Secondary ID [1] 311617 0
None
Universal Trial Number (UTN)
Trial acronym
MBSR: Mindfulness-Based Stress Reduction Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 333047 0
Mental health 333048 0
Metabolic health 333049 0
Condition category
Condition code
Metabolic and Endocrine 329724 329724 0 0
Diabetes
Mental Health 329725 329725 0 0
Anxiety
Mental Health 329726 329726 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MBSR intervention will be delivered by A/Prof Wendy Li, a qualified MBSR teacher certified by the Mindfulness Center at Brown University, with more than 15-year meditation experience. The in-person and online MBSR groups will meet once per week (2.5 hours per session) for 8 weeks, plus a 6-hour teacher-guided retreat session on the Saturday of Week 6, in person or via zoom, respectively, At least one medical practitioner or clinical psychologist will be on site during the intervention to provide clinical support to participants if needed.

The current RCT is a trial in which subjects are randomly assigned to one of three groups: one in-person MBSR group and one online MBSR group receiving the in-person and online MBSR intervention, respectively, which are being tested. The third group is the waiting list control group, receiving no treatments during the research duration, but receiving online MBSR intervention after the data collection completed.

The Brown University Mindfulness Centre’s Mindfulness-Based Stress Reduction (MBSR) Curriculum and Teaching Guide (2019) will be used to guide the MBSR intervention. The main guided meditation practices included in the curriculum are: 1) Eating meditation, which is a practice offers guidance in seeing, feeling, hearing and tasting the raisin in silence. Eating, as an ordinary activity in daily life, can support slowing down to allow time for various senses (e.g., smell, taste, hear) to register what is being received, time to gather the evidence of what this experience of eating actually is like. 2) Body-scan meditation, which emphasises “being in the body” to develop both concentration and flexibility of attention. It involves lying on the back, gradually moving attention through the body accompanied by awareness of breathing and other bodily sensations. 3) Sitting and attention focus meditation, where participants sit upright on a chair or cushion, during which attention is drawn to breathing. 4) Mindful hatha yoga, which consists of gentle stretching and strengthening exercises, moving very slowly, with moment-to-moment awareness of breathing and of the sensations during movement. 5) Walking mediation, which involves intentionally attending to the experience of walking itself, focusing on the sensations in the feet, legs and whole body while walking, and integrating awareness of breathing with the experience of walking.

Both in-person and online MBSR groups will employ the same MBSR curriculum. Two guided mindfulness meditations will be delivered every week: W1 - Eating medication and body scan; W2 - attention focus meditation and body scan; W3 - Lying down yoga and sitting meditation; W4 - Standing yoga and sitting meditation with more silence; W5 - Lying down Yoga and sitting meditation with more silence; W6 - Standing Yoga and sitting meditation with more silence; W7 - Walking meditation and sitting meditation with more silence; W8 - Body scan and sitting meditation with more silence. Session attendance checklists will be used to monitor adherence to the intervention.

Participants will be given guided meditation audio recordings to practice at home for 20-30 min, 6 days a week as homework assignments. In-class material emphasising the systematic development of mindfulness and its application in everyday life will be given. Additional discussion, which focuses on the psychology and physiology of stress reactivity and the application of mindfulness as a method for responding positively to stress, will be held in the class.

Participants in both intervention groups (The in-person and online MBSR) will be discouraged from making any changes in medication from the time of randomisation until after the follow-up assessment. Participants in the waiting list control group will be offered the MBSR intervention after the study is complete.

MBSR is considered as relatively safe, but ethical aspects should be considered. Participants may experience stress and discomfort during the process of psychological change. Unwanted thoughts, emotions, and sensations may arise during the meditation practices. To minimise the discomfort, an individual pre-intervention interview will be held one month before commencing the intervention where the researcher will discuss these difficulties and provide a clear rationale for how the program may help with participants' concerns. During the intervention, the instructor will remind participants not to push beyond limits of safety or tolerance and suggest ways to adapt practices if difficulties that feel overwhelming arise (e.g., opening the eyes or changing position to stabilize emotions and body sensations).
Intervention code [1] 328076 0
Prevention
Comparator / control treatment
The control group will be a waiting list control. The online only MBSR intervention will be offered two month after the 8 week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 337522 0
Depression
Timepoint [1] 337522 0
Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.
Primary outcome [2] 337523 0
Stress
Timepoint [2] 337523 0
Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.
Primary outcome [3] 337524 0
Metabolic profile
Timepoint [3] 337524 0
Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.
Secondary outcome [1] 432201 0
Sleep
Timepoint [1] 432201 0
Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.
Secondary outcome [2] 432202 0
Pain
Timepoint [2] 432202 0
Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.
Secondary outcome [3] 432203 0
Mindfulness
Timepoint [3] 432203 0
Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.
Secondary outcome [4] 433094 0
Anxiety (this is an additional [primary outcome).
Timepoint [4] 433094 0
Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.

Eligibility
Key inclusion criteria
Patients who 1) are aged 18 years or over; 2) have been diagnosed with Type 1 or Type 2 diabetes for at least 6 months; 3) have a stable antidiabetic medication dosage; and 4) speak fluent English and have attained at least a Year Seven reading ability.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who 1) experience significant comorbidities including cardiac, respiratory, or renal failures; 2) malignancies other than basal cell carcinoma; 3) current substance dependence (as measured by DSM-V criteria); 4) current psychotic disorder (e.g., schizophrenia, bipolar disorder); 5) prominent current suicidal ideation; 6) change in dosage, or began new, psychotropic medication in the previous 2 months; 7) a severe cognitive disorder (e.g., dementia or severe traumatic brain injury); 8) a clinically significant unstable or severe medical condition; and 9) prior participation in a MBSR program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation will employed in the study. Factors used for the stratification include type 1 or type 2 diabetes, sex and age.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The effect of the intervention will be assessed using a series of mixed-model ANOVA. In the mixed-model ANOVA, the outcome variable is the dependent variable, the conditions (treatment: in-person MBSR, online MBSR and waiting-list control) will be the between-group factor and time (time: pretest, in-session tests, posttest, and follow-up) will be the within-group factor. The mixed-model ANOVA will be conducted to determine whether any change in the outcome variable is the result of the interaction between the type of treatment and time. If there is no interaction between treatment and time, follow-up tests will be performed to determine whether any change in the outcome variable is caused one of the factors (i.e., conditions or time). Cohen’s d will be computed as effect size measures for all statistical comparisons (to speak to the practical, clinical relevance of findings).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26220 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 42187 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 315925 0
Hospital
Name [1] 315925 0
Townsville Hospital and Health Service
Country [1] 315925 0
Australia
Primary sponsor type
Hospital
Name
Townsville Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 318078 0
University
Name [1] 318078 0
James Cook University
Address [1] 318078 0
Country [1] 318078 0
Australia
Other collaborator category [1] 282966 0
University
Name [1] 282966 0
Santa Clara University
Address [1] 282966 0
Country [1] 282966 0
United States of America
Other collaborator category [2] 282967 0
University
Name [2] 282967 0
The University of Miami
Address [2] 282967 0
Country [2] 282967 0
United States of America

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314773 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314773 0
Ethics committee country [1] 314773 0
Australia
Date submitted for ethics approval [1] 314773 0
05/01/2024
Approval date [1] 314773 0
Ethics approval number [1] 314773 0
Ethics committee name [2] 314775 0
James Cook University Human Research Ethics Committee
Ethics committee address [2] 314775 0
Ethics committee country [2] 314775 0
Australia
Date submitted for ethics approval [2] 314775 0
01/04/2024
Approval date [2] 314775 0
Ethics approval number [2] 314775 0

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

Contacts
Principal investigator
Name 132678 0
Dr Omer Shareef Mohamed Ali
Address 132678 0
100 Angus Smith Drive, Townsville Queensland 4814, Townsville University Hospital
Country 132678 0
Australia
Phone 132678 0
+61 7 4433 1111
Fax 132678 0
Email 132678 0
[email protected]
Contact person for public queries
Name 132679 0
Wendy Li
Address 132679 0
1 James Cook Drive, James Cook University, Townsville, QLD 4811
Country 132679 0
Australia
Phone 132679 0
+61747816850
Fax 132679 0
Email 132679 0
[email protected]
Contact person for scientific queries
Name 132680 0
Wendy Li
Address 132680 0
1 James Cook Drive, James Cook University, Townsville, QLD 4811
Country 132680 0
Australia
Phone 132680 0
+61747816850
Fax 132680 0
Email 132680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data with individual participant data of published results only.
When will data be available (start and end dates)?
30/06/2027 - 30/06/2042
Available to whom?
Researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of the data manager.
Available for what types of analyses?
Research that achieves the aims in the approved proposal and for meta-analyses.
How or where can data be obtained?
The non-identifiable data related to our peer-reviewed publications will be Conditional Open Access (i.e. access to data is negotiated via one of our Principal Investigators A/Prof Wendy Li via [email protected]) through a data link with a unique Digital Object Identifier (DOI).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21759Analytic code    The codebook will be stored along with the de-iden... [More Details]



Results publications and other study-related documents

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