Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000722594p
Ethics application status
Submitted, not yet approved
Date submitted
29/05/2024
Date registered
12/06/2024
Date last updated
12/06/2024
Date data sharing statement initially provided
12/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
An exploration of different types of mindfulness practice on wellbeing outcomes
Scientific title
Evaluating the effectiveness of formal vs. informal mindfulness practice instruction - a four-arm randomised controlled trial in healthy adults
Secondary ID [1] 312125 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
general population wellbeing 333768 0
Condition category
Condition code
Mental Health 330443 330443 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a four-arm randomised controlled experiment. Participants will randomly be assigned to one of four groups: 1) Informal mindfulness practice instructions only, 2) Formal mindfulness practice instructions only, 3) both informal and formal mindfulness practice instructions, 4) a waitlist control group who will not receive any intervention for the duration of the study.
Each of the three mindfulness instruction groups will participate in five mindfulness classes, taking place online (via Zoom) for one hour once a week over five weeks. Mindfulness instructions for each of the intervention groups include introductions, instructions to the different types of practices (i.e. formal practice, informal practice depending on group assignment) and psycho-education on mindfulness.
Mindfulness classes are going to be delivered via trained health professionals who are experienced in delivering mindfulness instructions, and who have experience of delivering this mindfulness course (when it is formal and informal mindfulness practice, i.e. group 3). Prior to commencement of the study, the mindfulness teachers will receive training of one hour by the study researchers to make sure they only teach the relevant components for each class, i.e. for group 1, only focus on informal mindfulness practice instruction, for group 2, only focus on formal mindfulness practice instruction, and for group 3, focus on both, formal and informal mindfulness practice instruction. Participants will only receive instructions that relate to their particular group (e.g., the informal mindfulness practice group only receives instructions about informal practices, the formal mindfulness practice group only about formal practices, etc.). Groups that include formal mindfulness practice instructions, i.e., the group that only receives formal mindfulness practice instructions as well as the group receiving instructions on both, formal and informal practice, will also be given audio recordings of practices (via email) to be completed outside of sessions, as is customary for most mindfulness programs. These formal mindfulness practices are guided audio recordings of meditation ranging from 5 minutes to 10 minutes. These audio recordings focus on paying attention on present moment experiences, such as the sensations of breathing, and/or paying particular attention to the body, guided by Prof Craig Hassed, who is an experienced mindfulness teacher and who has recorded these audio tracks. Informal mindfulness practice instructions on the other hand are only given during the live sessions with the mindfulness teacher, where participants are ask to mindfully pay attention to particular tasks they are doing throughout their day, such as being mindful when washing dishes/brushing teeth, etc. The session content has been adapted from an existing mindfulness course by Prof Craig Hassed (M3CS, Monash University). Participant adherence will be monitored at the beginning of each session by the session instructors, and by self-report measures.
Intervention code [1] 328561 0
Lifestyle
Intervention code [2] 328747 0
Behaviour
Comparator / control treatment
Waitlist control.
The waitlist control group is given access to participate in an online mindfulness course after completion of the study (i.e. after post-measures have been collected), namely Mindfulness for Wellbeing and Peak Performance (https://www.monash.edu/trainingforhumanity/mindfulness-for-wellbeing-and-peak-performance). This online mindfulness course is very similar to the mindfulness course the intervention groups participants will be receiving, and was developed by the same people, i.e. Prof Craig Hassed at Monash University, Australia.
Control group
Active

Outcomes
Primary outcome [1] 338220 0
Depression
Timepoint [1] 338220 0
Baseline and post-intervention (week 5)
Secondary outcome [1] 435036 0
Anxiety
Timepoint [1] 435036 0
Baseline and post-intervention (week 5)
Secondary outcome [2] 435037 0
Stress
Timepoint [2] 435037 0
Baseline and post-intervention (week 5)
Secondary outcome [3] 435038 0
Trait mindfulness
Timepoint [3] 435038 0
Baseline and post-intervention (time 5)
Secondary outcome [4] 435039 0
State mindfulness
Timepoint [4] 435039 0
Baseline and post-intervention (time 5)
Secondary outcome [5] 435040 0
Positive affect
Timepoint [5] 435040 0
Baseline and post-intervention (time 5)
Secondary outcome [6] 435041 0
Negative affect
Timepoint [6] 435041 0
Baseline and post-intervention (week 5)
Secondary outcome [7] 435042 0
mindful adherence (informal, formal, informal and formal)
Timepoint [7] 435042 0
Once a week for intervention groups, from week one until week five.
Secondary outcome [8] 435043 0
Ecological momentary assessment of mindfulness practice
Timepoint [8] 435043 0
Daily for intervention groups, from week one until week five.

Eligibility
Key inclusion criteria
Adults aged at least 18 from the general population.
Meditation naive participants with limited prior mindfulness practice experience and no current mindfulness practice.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with extensive prior experience of mindfulness or who currently practice mindfulness are asked not to participate in the study.

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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316483 0
Charities/Societies/Foundations
Name [1] 316483 0
Monash Centre for Consciousness and Contemplative Studies
Country [1] 316483 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Country
Australia
Secondary sponsor category [1] 318658 0
University
Name [1] 318658 0
Monash University
Address [1] 318658 0
Country [1] 318658 0
Australia
Other collaborator category [1] 283045 0
Individual
Name [1] 283045 0
Prof Craig Hassed
Address [1] 283045 0
Country [1] 283045 0
Australia
Other collaborator category [2] 283046 0
Individual
Name [2] 283046 0
Prof Jakob Hohwy
Address [2] 283046 0
Country [2] 283046 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315280 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 315280 0
https://www.vu.edu.au/researchers/research-lifecycle/conducting-research/human-research-ethics/vu-human-research-ethics-committee-vuhrec
Ethics committee country [1] 315280 0
Australia
Date submitted for ethics approval [1] 315280 0
11/06/2024
Approval date [1] 315280 0
Ethics approval number [1] 315280 0

Summary
Brief summary
This study aims to further understand the difference in teaching formal and informal mindfulness practices, and the effect on dose of formal and informal practices on wellbeing outcomes. Additionally, this project aims to further examine dose-response in mindfulness programs, by in particular focusing on instructions of formal and informal practice, and whether participants follow guidance of formal and informal practice in different ways, and/or develop their own informal practices from being given instructions on different types of practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134206 0
Dr Sarah Strohmaier
Address 134206 0
Victoria University 70/104 Ballarat Rd, Footscray VIC 3011
Country 134206 0
Australia
Phone 134206 0
+61 3 9919 5828
Fax 134206 0
Email 134206 0
sarah.strohmaier@vu.edu.au
Contact person for public queries
Name 134207 0
Dr Sarah Strohmaier
Address 134207 0
Victoria University 70/104 Ballarat Rd, Footscray VIC 3011
Country 134207 0
Australia
Phone 134207 0
+61 3 9919 5828
Fax 134207 0
Email 134207 0
sarah.strohmaier@vu.edu.au
Contact person for scientific queries
Name 134208 0
Dr Sarah Strohmaier
Address 134208 0
Victoria University 70/104 Ballarat Rd, Footscray VIC 3011
Country 134208 0
Australia
Phone 134208 0
+61 3 9919 5828
Fax 134208 0
Email 134208 0
sarah.strohmaier@vu.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?

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.