Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001205628
Ethics application status
Approved
Date submitted
20/10/2023
Date registered
23/11/2023
Date last updated
23/11/2023
Date data sharing statement initially provided
23/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of the effectiveness of mindfulness training and computerized working memory training in improving working memory performance of healthy adults in the age range between 18 and 55 years
Scientific title
A comparison of the effectiveness of mindfulness training and computerized working memory training in improving working memory performance of healthy adults
Secondary ID [1] 310827 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
working memory deficit 331832 0
Condition category
Condition code
Mental Health 328567 328567 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 is our intervention group and participants in this group will complete working memory game training. Participants will be able to complete their training via an already developed brain training website call the DREAM website. The website was developed by Professor Jan L. Plass of the New York University. Participants will be expected to complete their training online from the comfort of their home. The game is called 'CrushStations' and has similarities with the n-back task, a measure of working memory popularly used in working memory training research studies. The game is made adaptive which means that difficulty level is increased based on participant's performance. Participants will have different types and colors of sea creatures displayed on their screen to remember, and will be asked to recall the type and color of the sea creatures at a later recall test. Participants will be expected to train four days a week for six weeks altogether, and for twenty one minute in each sitting. To monitor adherence to the intervention, participants will be informed via a Plain Language Statement and Consent Form that the DREAM website will share their training information with the Deakin research team about how frequently they completed their training, including number of minutes spent completing training in each sitting, total number of days trained in a week, number of weeks trained altogether and levels completed altogether.
Intervention code [1] 327239 0
Treatment: Other
Comparator / control treatment
Group 2 is our active control group. Participants in Group 2 will complete mindfulness training online via the Mindfulness Coach Explorer app. Participants will be asked to listen to recorded guided meditation that facilitates open monitoring of thought processes and promotes acceptance and awareness of thoughts and emotions. Through the recorded meditation script, participants will also practice focused attention meditation where they will be guided to bring their attention on an object such as their breath, and as their mind wanders to distracting thoughts, they will be gently guided to bring their awareness back to their breathing, nonjudgmentally and in an accepting manner. Participants will be expected to train for 21 minutes in each sitting, for 4 days a week and for 6 weeks altogether. Participants consent in Plain Language Statement and Consent Form that the Mindfulness Coach Explorer App will share their training information of research participants with the with the research team. This information includes number of minutes trained in each sitting, number of minutes trained each week, and number of weeks trained altogether.
Control group
Active

Outcomes
Primary outcome [1] 336373 0
Working memory is our primary outcome
Timepoint [1] 336373 0
Baseline and six weeks post-baseline
Primary outcome [2] 336528 0
Reasoning ability is an additional primary outcome.
Timepoint [2] 336528 0
Baseline and six weeks post-baseline
Primary outcome [3] 336529 0
Mind-wandering is an additional primary outcome.
Timepoint [3] 336529 0
Baseline and six weeks post-baseline
Secondary outcome [1] 428092 0
Depression and Anxiety are assessed as composite outcome
Timepoint [1] 428092 0
Baseline and 6 weeks post-baseline
Secondary outcome [2] 428697 0
Mindfulness is our primary outcome
Timepoint [2] 428697 0
Baseline and six weeks post baseline

Eligibility
Key inclusion criteria
Healthy adults on the age range between 18 and 55 years without a current diagnosis of a psychological or neurological condition
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anyone above the age of 55 years and below the age of 18 years.
Anyone with a current diagnosis of psychological or neurological condition (including but not limited to, severe traumatic brain injury, stroke, brain tumours, dementia or other neurodegenerative disease, epilepsy, or intellectual disability)

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)
Allocation was concealed via Qualtrics that randomly assigns participants to either of the training groups without the researchers' approval
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomly assigned to either of the training groups without the researchers' awareness done by Qualtrics
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2023
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
120
Accrual to date
23
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25912 0
New Zealand
State/province [1] 25912 0
Country [2] 25913 0
United States of America
State/province [2] 25913 0

Funding & Sponsors
Funding source category [1] 315075 0
University
Name [1] 315075 0
Deakin University
Country [1] 315075 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 317093 0
None
Name [1] 317093 0
Address [1] 317093 0
Country [1] 317093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314021 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 314021 0
221 Burwood Highway, Burwood VIC 3125
Ethics committee country [1] 314021 0
Australia
Date submitted for ethics approval [1] 314021 0
10/04/2022
Approval date [1] 314021 0
21/12/2022
Ethics approval number [1] 314021 0

Summary
Brief summary
Participants are asked to fill in 4 online questionnaires of memory, mindfulness, attention, mood and mind-wandering, and complete two online tasks of working memory and reasoning ability prior to training. Participants are asked to complete similar tests after the training is completed. After completing baseline measures, participants are then randomly assigned to either of the training groups (mindfulness training or computerised working memory training). Working memory training group is our intervention group and participants in this group will complete their training from the DREAM website by playing CrushStations game. The game is based on the principles of n-back task, a measure of working memory capacity popularly used in working memory training research. Different types and colors of ocean animals will be displayed on participant's screen, and at a later recall test, participants will be asked to recall and remember types and colors of ocean animals. Group 2 is our active control group where participants will complete mindfulness training via the Mindfulness Coach Explorer app. Participants will practice open monitoring and focused attention types of meditation during their training. Both groups will train for 21 minutes in each sitting, for 4 days a week and for 6 weeks altogether.

It is hypothesised that working memory training group will show improved performance at post-test on the measures of working memory and reasoning ability, whereas mindfulness training group will show improved performance on the measures of mood, mind-wandering, and mindfulness trait.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 130150 0
Dr David Skvarc
Address 130150 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 130150 0
Australia
Phone 130150 0
+61 352272541
Fax 130150 0
Email 130150 0
david.skvarc@deakin.edu.au
Contact person for public queries
Name 130151 0
Dr David Skvarc
Address 130151 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 130151 0
Australia
Phone 130151 0
+61 352272541
Fax 130151 0
Email 130151 0
david.skvarc@deakin.edu.au
Contact person for scientific queries
Name 130152 0
Dr David Skvarc
Address 130152 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 130152 0
Australia
Phone 130152 0
+61 352272541
Fax 130152 0
Email 130152 0
david.skvarc@deakin.edu.au

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20701Clinical study report    Intending to publish in an open access journal onc... [More Details]



Results publications and other study-related documents

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Documents added automatically
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