Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001922268p
Ethics application status
Submitted, not yet approved
Date submitted
14/11/2018
Date registered
26/11/2018
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindful or mind-full? An eight-week program on mental health and quality of life in people with multiple sclerosis
Scientific title
Mindfulness program for improving mental health and quality of life in people with multiple sclerosis: a pilot, randomised controlled trial
Secondary ID [1] 296607 0
None
Universal Trial Number (UTN)
U1111-1223-9898
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 310414 0
Quality of life 310415 0
Condition category
Condition code
Neurological 309129 309129 0 0
Multiple sclerosis
Public Health 309130 309130 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Mindfulness-based cognitive therapy (face to face, 8x2hour sessions, once/week for 8 weeks, at MSWA office, delivered by trained MBCT clinical psychologist, plus a daily 20 minute home practice)
Arm 2: Mindfulness-based cognitive therapy (online, 8x2hour sessions, once/week for 8 weeks, at participants' home or their preferred place, delivered by trained MBCT clinical psychologist, plus a daily 20 minute home practice)
Arm 3: yoga (face to face, 8x2hours sessions, once/week for 8 weeks, at Yoga Space studio, delivered by trained yoga teacher trainee, plus a daily 20 minute home practice)
Arm 4: wait-list control group (receive yoga after 8 weeks, face to face, 8x2hours sessions, once/week for 8 weeks, at Yoga Space studio, delivered by trained yoga teacher trainee, plus a daily 20 minute home practice)

The MBCT intervention includes cognitive therapy and mindfulness practice. Each of the weekly session involves learning to disengage and detach from habitual ruminative thoughts and action, being aware of the warning signs, choosing an action (instead of the habitual destructive thoughts and actions) when encountering potential stressors and maintaining mindful practices in daily routines. Participants will also have a handbook. Depending on the level of commitment the participants could commit to at the screening phase, a brief MBCT (maximum 75-90 minutes per session) might be provided instead of the full MBCT program to allow people with MS but are time-poor to participate. The brief MBCT program is based on the same model and content, but shortened and valid. It also allows people without formal diagnosis of depression to participate, which is likely to be more inclusive of most people with MS.
The yoga will be similar to a stretching yoga (Hatha yoga) adaptable for wheelchair-bound participants (if any).

The trained MBCT clinical psychologist will record attendance at each session. Adherence to home practice will be recorded at each four-week interval for the six-month follow-up by asking intervention participants to note in their diaries “On average, how many minutes per day and days per week did you practise active mindfulness every week, such as in the form of body scan, mindful movement or breath meditation?”, “Which practice did you use?”, “What obstacles have you experienced while trying to practise?,”, “What insights did you gain while practising (if any)?”, “Comment on overall benefit of practice since the last time".
Intervention code [1] 312915 0
Behaviour
Comparator / control treatment
The control group will be a wait-list control group, where they wait and not receive anything in the first 8 weeks of the study (when the other 3 arms receive intervention), then receive yoga intervention.
Control group
Active

Outcomes
Primary outcome [1] 308111 0
score from Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [1] 308111 0
immediately after the 8-week program (primary endpoint), and monthly over a 6-month follow up period.
Secondary outcome [1] 353981 0
Quality of life score from the Multiple Sclerosis Quality of Life questionnaire (MSQOL-54)
Timepoint [1] 353981 0
immediately after the 8-week program (primary endpoint), and monthly over a 6-month follow up period.

Eligibility
Key inclusion criteria
people who are aged greater than or equal to 18 years, with a diagnosis of multiple sclerosis, not currently using psychotropic drugs or undergoing psychological treatment, able to speak and understand English, and have internet access
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants who score greater than or equal to 14, 10, or 17 for depression, anxiety and stress (respectively) on the Depression, Anxiety and Stress Scale (DASS-21) are in the extremely severe category and will not be invited to participate in this pilot study but will be advised to visit their doctor.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Differences between scores at baseline and across the follow-up time points will be assessed using general linear mixed effects model. The model will allow comparison within participants over time and between the groups, while allowing a time*group interaction. While we endeavor to ensure data are collected at each follow-up time point by sending reminders and contacting the participants, should there be missing data the model can also allow random effect from the individuals. Baseline score, time since diagnosis of MS, and time spent on home practice will be included in the model.
The target sample size for this pilot study is 100. This number allows a conservative correlation of 0.8 between the baseline and follow-up scores and is powered (80% power and 5% significance level) to detect a medium effect size of 0.48.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/01/2019
Actual
Date of last participant enrolment
Anticipated
3/06/2019
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 24680 0
6000 - Perth
Recruitment postcode(s) [2] 24681 0
6102 - Bentley
Recruitment postcode(s) [3] 24682 0
6107 - Wilson

Funding & Sponsors
Funding source category [1] 301186 0
Self funded/Unfunded
Name [1] 301186 0
unfunded as on 26th November 2018
Country [1] 301186 0
Primary sponsor type
University
Name
Curtin University
Address
School of Public Health, Kent Street, Bentley, WA6102, Australia.
Country
Australia
Secondary sponsor category [1] 300808 0
None
Name [1] 300808 0
Address [1] 300808 0
Country [1] 300808 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301926 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 301926 0
Kent Street, Bentley, WA 6102
Ethics committee country [1] 301926 0
Australia
Date submitted for ethics approval [1] 301926 0
17/09/2018
Approval date [1] 301926 0
Ethics approval number [1] 301926 0

Summary
Brief summary
The primary aim of this pilot is to improve understanding of acceptability and benefits of an online and a face-to-face mindfulness-based cognitive therapy (MBCT) program for people with MS, and to generate preliminary data to inform the development of a larger multi-centre, randomised controlled trial (RCT) in order to promote wellness and quality of life of people with MS. This study aims to: 1) evaluate acceptability of an online and a face-to-face MBCT program against a yoga intervention, its overall effect on mental health and quality of life, and enablers and barriers to incorporating the mindfulness practice at home sustainably; 2) assess if there is improvement in mental health and quality of life in participants from baseline and immediately after the an online or a face-to-face MBCT program or against a yoga intervention and over a six-month follow-up after the program; and 3) evaluate economic data on the cost-effectiveness of the online and face-to-face MBCT program against the yoga intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88586 0
Dr Jun Chih
Address 88586 0
School of Public Health,
Curtin University,
Kent Street,
Bentley, WA 6102
Country 88586 0
Australia
Phone 88586 0
+61892662139
Fax 88586 0
Email 88586 0
[email protected]
Contact person for public queries
Name 88587 0
Dr Jun Chih
Address 88587 0
School of Public Health,
Curtin University,
Kent Street,
Bentley, WA 6102
Country 88587 0
Australia
Phone 88587 0
+61892662139
Fax 88587 0
Email 88587 0
[email protected]
Contact person for scientific queries
Name 88588 0
Dr Jun Chih
Address 88588 0
School of Public Health,
Curtin University,
Kent Street,
Bentley, WA 6102
Country 88588 0
Australia
Phone 88588 0
+61892662139
Fax 88588 0
Email 88588 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Pending on ethics application


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial to test the feasibility of online mindfulness programs for people with multiple sclerosis.2021https://dx.doi.org/10.1016/j.msard.2020.102728
N.B. These documents automatically identified may not have been verified by the study sponsor.