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Trial registered on ANZCTR


Registration number
ACTRN12625000010493
Ethics application status
Approved
Date submitted
14/11/2024
Date registered
8/01/2025
Date last updated
8/01/2025
Date data sharing statement initially provided
8/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A tailored mindfulness intervention for university students with varying mental imagery abilities
Scientific title
Enhancing Mindfulness Interventions: The Role of Visual Imagery Ability on Mindfulness Outcome in University Students.
Secondary ID [1] 313382 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychological distress 335750 0
Condition category
Condition code
Mental Health 332305 332305 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness Intervention: The intervention material was adapted from module content from the unified protocol for the transdiagnostic treatment of emotional disorders (Ehrenreich-May et al., 2017). It consists of psychoeducation on present-focused attention, utilizing different bodily senses to observe their (or the virtual) environment. The intervention prompts breath control, somatic experiences and feeling throughout the body, observing thought content, and prompted the observation of one's own emotional experiences (i.e., emotional awareness),

VR condition - The virtual environment/ video content was recorded using a 360-degree VR camera (GoPro Hero).
The audio recording was played in conjunction with a 10-minute recording of a natural environment (i.e., a creek situated in natural bushland). While viewing the scenery, participants listened to the voice-over and focused their attention on their feelings, thoughts, breathing, and the virtual environment. The audio mindfulness was delivered verbally by a provisionally registered psychologist, practicing under supervision.

Traditional Mindfulness/ Audio Only: The content of the traditional mindfulness group uses the same audio and script recording of the mindfulness meditation delivered in the VR activity, except that participants will navigate play the audio file on their smartphone device and have the option to listen to this with or without their own headphones.

Control Group. The control condition required participants to watch a 10-minute video on YouTube pertaining to finance and the stock market. complete an online educative module on hand hygiene practices. Participants will follow study prompts/ instructions to access the intervention landing page using their preferred web-browser on their smartphone device.

Adherence was monitored using website data and metrics to access participants time spent playing the intervention recording. Supervision of participants through observation was not conducted as the study wanted to replicate (as best as possible) a more externally valid experience of participants autonomously accessing and completing the intervention as they would, were they to access the intervention outside of the research lab.

Participants register through an online form and are then randomly allocated to either of the three treatment conditions: virtual reality condition, traditional mindfulness condition, control condition. A link will be emailed to participants to access
the pre-intervention questionnaire package through Qualtrics. They are to be instructed to complete this before entering the intervention space.

Upon completion of the screening and pre-questionnaires and group allocation, participants selected a time to come to the intervention space located at their respective Griffith university campus (either Gold Coast or Mount Gravatt). Those in the VR condition were given face-to-face instructions to set up the HMD and access the intervention prior to use. Those in the traditional group were also given instruction to engage with the mindfulness audio and those in the control task were also assisted with accessing their youtube audio on the university ipads with headphones. The treatment space was set up in an inviting but least distracting way in case participants in the traditional group were to open their eyes. Participants in all groups completed the intervention alone in the soundproof intervention space with the supervisor on stand-by for troubleshooting and assistive purposes. After completion, participants were directed to the online post-intervention questionnaires. One-week following the participation, participants were emailed the follow-up questionnaires and completed. Course credit was then awarded for participants completing all stages of the intervention.

The total duration to complete the entire intervention including the questionnaires is approximately 2 hours:
- 30 minutes (pre-intervention questionnaire)
- 15 minutes (intervention + time allocated for troubleshooting and set-up)
- 30 minutes (post-intervention questionnaire)
- 30 minutes (one-week follow-up questionnaire)
Intervention code [1] 329962 0
Treatment: Other
Comparator / control treatment
The participants in the active control condition will receive the same questionnaire packages and experience the intervention for the same length of time (10 minutes). However the intervention will be mindful listening to audio of a news broadcast. Content is based around the economic opportunity of artificial intelligence and was drawn from YouTube. Participants were prompted to focus their attention on their thoughts and feelings while listening to the audio, and would access it on their personal devices or university iPads if required
Control group
Active

Outcomes
Primary outcome [1] 339883 0
Mindfulness state as measured by the Toronto Mindfulness Scale
Timepoint [1] 339883 0
Pre-intervention, post-intervention and 1-week follow-up
Secondary outcome [1] 441746 0
Engagement
Timepoint [1] 441746 0
Pre-intervention, post-intervention and 1-week follow-up
Secondary outcome [2] 441747 0
Acceptance and Use
Timepoint [2] 441747 0
Pre-intervention, post-intervention and 1-week follow-up
Secondary outcome [3] 443207 0
Positive affect
Timepoint [3] 443207 0
Pre-intervention, post-intervention and 1-week follow-up
Secondary outcome [4] 443208 0
Negative affect
Timepoint [4] 443208 0
Pre-intervention, post-intervention and 1-week follow-up
Secondary outcome [5] 443209 0
Depression
Timepoint [5] 443209 0
Pre-intervention, post-intervention and 1-week follow-up
Secondary outcome [6] 443211 0
Anxiety
Timepoint [6] 443211 0
Pre-intervention, post-intervention and 1-week follow-up
Secondary outcome [7] 443213 0
Stress
Timepoint [7] 443213 0
Pre-intervention, post-intervention and 1-week follow-up
Secondary outcome [8] 443214 0
Intervention Credibility
Timepoint [8] 443214 0
Pre-intervention, post-intervention and 1-week follow-up
Secondary outcome [9] 443215 0
Intervention Expectancy
Timepoint [9] 443215 0
Pre-intervention, post-intervention and 1-week follow-up
Secondary outcome [10] 443216 0
Satisfaction
Timepoint [10] 443216 0
Pre-intervention, post-intervention and 1-week follow-up
Secondary outcome [11] 443606 0
Psychological Distress
Timepoint [11] 443606 0
Pre-intervention

Eligibility
Key inclusion criteria
Participants needed to be aged 17 years or above, and enrolled to study within a tertiary university.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Does not own a smartphone device
Not enrolled in a program of study at the university conducting the research

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)
Central randomisation on a computer by using a random number sequence generator program.
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

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
Multiple regression, mixed factorial ANOVAs

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/01/2025
Actual
Date of last participant enrolment
Anticipated
16/05/2025
Actual
Date of last data collection
Anticipated
23/05/2025
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317823 0
University
Name [1] 317823 0
Griffith University
Country [1] 317823 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 320153 0
None
Name [1] 320153 0
Address [1] 320153 0
Country [1] 320153 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316507 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316507 0
https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-research-ethics-committee
Ethics committee country [1] 316507 0
Australia
Date submitted for ethics approval [1] 316507 0
03/10/2024
Approval date [1] 316507 0
31/10/2024
Ethics approval number [1] 316507 0

Summary
Brief summary
The purpose of this study is to explore an alternate delivery modality for mindfulness that may account for deficits in mental imagery, a necessary component for effective mindfulness practice. It is predicted that mental imagery ability will mediate the relationship between treatment modality and mindfulness outcomes. It is also predicted that participants with poorer mental imagery will have improved outcomes within the VR condition compared to the Traditional mindfulness condition. Pending our hypotheses are correct, this study will provide a foundation for researchers to build upon. A successful intervention will provide a blueprint for improved service delivery, strengthen the status of mindfulness as a transdiagnostic treatment that can be effective for a diverse range of populations and encourage researchers to explore novel virtual reality approaches for mental health improvement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138114 0
Mr Dale Rowland
Address 138114 0
Griffith University, 1 University Drive, Southport QLD 4215
Country 138114 0
Australia
Phone 138114 0
+61 7056780993
Fax 138114 0
Email 138114 0
[email protected]
Contact person for public queries
Name 138115 0
Dale Rowland
Address 138115 0
Griffith University, 1 University Drive, Southport QLD 4215
Country 138115 0
Australia
Phone 138115 0
+61 7056780993
Fax 138115 0
Email 138115 0
[email protected]
Contact person for scientific queries
Name 138116 0
Dale Rowland
Address 138116 0
Griffith University, 1 University Drive, Southport QLD 4215
Country 138116 0
Australia
Phone 138116 0
+61 7056780993
Fax 138116 0
Email 138116 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
Pending approval from research institute


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.