Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000599572
Ethics application status
Approved
Date submitted
24/04/2024
Date registered
9/05/2024
Date last updated
11/07/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness and personality in the general population
Scientific title
Evaluating the effectiveness of mindfulness practice in the general population through personalization - a randomized controlled experiment
Secondary ID [1] 312102 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 333640 0
Condition category
Condition code
Mental Health 330326 330326 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a three-arm randomised controlled trial of a single mindfulness practice versus control.
Arm 1: 20 minute mindfulness practice and 5 minute audiobook excerpt
Arm 2: 5 minute mindfulness practice and 20 minute audiobook excerpt
Arm 3: active control: 25 minute audiobook excerpt
The single mindfulness practices (in arms 1 and 2) are mindfulness of the breath meditation practices recorded by a qualified MCBT (Mindfulness-Based Cognitive Therapy) teacher, Dr Fergal Jones, which have previously been proven feasible in published research (Strohmaier et al. (2021): https://link.springer.com/article/10.1007/s12671-020-01512-5)
Participants will start with the audiobook excerpt, immediately after which the mindfulness practice takes place (this has previously been tested and has proven successful in another study, see Strohmaier et al. (2021).
The mode of delivery is individual and online, which has previously been tested and proven successful in another study, see Strohmaier et al. (2022): https://link.springer.com/article/10.1007/s12671-021-01780-9
The intervention takes place fully online via the survey software Qualtrics, as has previouly proven feasible (see Strohmaier et al. (2022) above link). The Qualtrics survey will be built by the researcher who has previous experience in this.
The location of the intervention is online, and participants are asked to make sure that they are not disturbed during the time of the intervention, which should take no longer than 40 minutes to complete (for the whole intervention in total).
To monitor adherence, participants will be unable to click through to the next page on Qualtrics for 25 minutes during the duration of the study, since the "next" button will not appear until after 25 minutes have taken place, as has proven feasible in previous research (see Strohmaier et al. (2022)). However, participants have the right to withdraw from the study at any time without giving a reason, as will be communicated to them prior to commencement of the study as part of the study information.
Participants in all three arms will be asked to indicate from 1 to 10 how well they were able to pay attention to the recording, and participants in arms 1 and 2 will also be asked how much they were able to follow the guidance during the practice, again to indicate from 1 to 10 (as has proven feasible in previous research, Strohmaier et al. 2022).
This study seeks to determine whether some individuals (based on personality) find different lengths of a mindfulness practice more helpful than others. In this study, the impact on affect of two different lengths of mindfulness practice (and a no-practice control group) are compared across personality types.
Data will be collected online from an adult general population sample, building on an approach that has proven feasible in the Principal Investigator’s previously published research. The current study should help future mindfulness-based programs to better personalize the mindfulness practices they offer, resulting in better outcomes for their participants.
Intervention code [1] 328481 0
Other interventions
Comparator / control treatment
The control group is an active control group and will be asked to listen to 25 minutes of an audio book excerpt, namely Bill Bryson's "A short History of Nearly Everything".
The two intervention groups will be supplemented with excerpts from the same audiobook to avoid length of time effects influencing results (i.e. each group listens to something for 25 minutes)
Control group
Active

Outcomes
Primary outcome [1] 338080 0
positive affect
Timepoint [1] 338080 0
pre (baseline) and post mindfulness practice/active control
Primary outcome [2] 338130 0
negative affect
Timepoint [2] 338130 0
pre (baseline) and post mindfulness practice/active control
Secondary outcome [1] 434426 0
state mindfulness
Timepoint [1] 434426 0
pre (baseline) and post mindfulness practice/active control

Eligibility
Key inclusion criteria
Adults aged at least 18 from the general population.
Recruitment is online through Prolific online recruitment services, public social media platforms, word of mouth, known associates of researcher.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are informed that if they are currently experiencing severe difficulties with their health, now is not the best time to take part in this research prior to agreeing to participate in this study.

Study design
Purpose of the study
Educational / counselling / training
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)
Permuted block randomisation
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2024
Actual
3/07/2024
Date of last participant enrolment
Anticipated
31/10/2025
Actual
5/07/2024
Date of last data collection
Anticipated
31/10/2025
Actual
5/07/2024
Sample size
Target
630
Accrual to date
Final
636
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26282 0
United Kingdom
State/province [1] 26282 0
Country [2] 26283 0
United States of America
State/province [2] 26283 0
Country [3] 26284 0
Canada
State/province [3] 26284 0
Country [4] 26285 0
New Zealand
State/province [4] 26285 0

Funding & Sponsors
Funding source category [1] 316384 0
University
Name [1] 316384 0
Victoria University
Country [1] 316384 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Country
Australia
Secondary sponsor category [1] 318567 0
None
Name [1] 318567 0
Address [1] 318567 0
Country [1] 318567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315190 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 315190 0
Ethics committee country [1] 315190 0
Australia
Date submitted for ethics approval [1] 315190 0
25/01/2024
Approval date [1] 315190 0
17/05/2024
Ethics approval number [1] 315190 0

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

Contacts
Principal investigator
Name 133938 0
Dr Sarah Strohmaier
Address 133938 0
Victoria University 70/104 Ballarat Rd, Footscray VIC 3011
Country 133938 0
Australia
Phone 133938 0
+61 3 9919 5828
Fax 133938 0
Email 133938 0
[email protected]
Contact person for public queries
Name 133939 0
Sarah Strohmaier
Address 133939 0
Victoria University 70/104 Ballarat Rd, Footscray VIC 3011
Country 133939 0
Australia
Phone 133939 0
+61 3 9919 5828
Fax 133939 0
Email 133939 0
[email protected]
Contact person for scientific queries
Name 133940 0
Sarah Strohmaier
Address 133940 0
Victoria University 70/104 Ballarat Rd, Footscray VIC 3011
Country 133940 0
Australia
Phone 133940 0
+61 3 9919 5828
Fax 133940 0
Email 133940 0
[email protected]

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?

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
No additional documents have been identified.