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Trial Review
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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
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Scientific title
Enhancing Mindfulness Interventions: The Role of Visual Imagery Ability on Mindfulness Outcome in University Students.
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Secondary ID [1]
313382
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
psychological distress
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Condition category
Condition code
Mental Health
332305
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
329962
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Treatment: Other
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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
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Control group
Active
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Outcomes
Primary outcome [1]
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Mindfulness state as measured by the Toronto Mindfulness Scale
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Assessment method [1]
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Participants will self-report on the Toronto Mindfulness Scale. This quantitative data will be used as the primary outcome for regression analysis to determine variables that predict mindfulness outcome.
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Timepoint [1]
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Pre-intervention, post-intervention and 1-week follow-up
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Secondary outcome [1]
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Negative affect
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Assessment method [1]
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The subscale score for negative affect will be used from the Positive and Negative Affect Scale
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Timepoint [1]
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Pre-intervention, post-intervention and 1-week follow-up
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Secondary outcome [2]
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Depression
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Assessment method [2]
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The subscale score for depression will be used from the Depression, Anxiety, and Stress Scales - 21-item version
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Timepoint [2]
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Pre-intervention, post-intervention and 1-week follow-up
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Secondary outcome [3]
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Acceptance and Use
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Assessment method [3]
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The composite score of the unified theory of acceptance and use of technology 2 (UTAUT-2). will be used. This is a self-report measure of acceptance and use of technology.
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Timepoint [3]
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Pre-intervention, post-intervention and 1-week follow-up
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Secondary outcome [4]
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Anxiety
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Assessment method [4]
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The subscale score for anxiety will be used from the Depression, Anxiety, and Stress Scales - 21-item version
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Timepoint [4]
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Pre-intervention, post-intervention and 1-week follow-up
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Secondary outcome [5]
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Positive affect
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Assessment method [5]
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The subscale score for positive affect will be used from the Positive and Negative Affect Scale
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Timepoint [5]
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Pre-intervention, post-intervention and 1-week follow-up
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Secondary outcome [6]
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Engagement
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Assessment method [6]
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The composite score of the electronic therapy attitudes and process questionnaire (eTAP) will be used. This is a self-report measure of engagement with digital mental health interventions.
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Timepoint [6]
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Pre-intervention, post-intervention and 1-week follow-up
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Secondary outcome [7]
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Intervention Expectancy
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Assessment method [7]
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The subscale score for intervention expectancy will be used from the Credibility/Expectancy Questionnaire
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Timepoint [7]
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Pre-intervention, post-intervention and 1-week follow-up
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Secondary outcome [8]
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Intervention Credibility
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Assessment method [8]
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The subscale score for intervention credibility will be used from the Credibility/Expectancy Questionnaire
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Timepoint [8]
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Pre-intervention, post-intervention and 1-week follow-up
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Secondary outcome [9]
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Satisfaction
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Assessment method [9]
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Composite score from the Client Satisfaction Questionnaire
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Timepoint [9]
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Pre-intervention, post-intervention and 1-week follow-up
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Secondary outcome [10]
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Stress
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Assessment method [10]
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The subscale score for stress will be used from the Depression, Anxiety, and Stress Scales - 21-item version
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Timepoint [10]
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Pre-intervention, post-intervention and 1-week follow-up
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Secondary outcome [11]
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Psychological Distress
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Assessment method [11]
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Participants will self-report on the Kessler Psychological Distress Scale (K10). Outcomes on this measure will indicate participants baseline psychological distress.
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Timepoint [11]
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Pre-intervention
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Eligibility
Key inclusion criteria
Participants needed to be aged 17 years or above, and enrolled to study within a tertiary university.
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Minimum age
17
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Does not own a smartphone device
Not enrolled in a program of study at the university conducting the research
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Multiple regression, mixed factorial ANOVAs
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
21/01/2025
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Actual
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Date of last participant enrolment
Anticipated
16/05/2025
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Actual
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Date of last data collection
Anticipated
23/05/2025
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Griffith University
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Griffith University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
320153
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Griffith University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-research-ethics-committee
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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03/10/2024
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Approval date [1]
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31/10/2024
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Ethics approval number [1]
316507
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Dale Rowland
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Address
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Griffith University, 1 University Drive, Southport QLD 4215
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Country
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Australia
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Phone
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+61 7056780993
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
138115
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Dale Rowland
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Address
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Griffith University, 1 University Drive, Southport QLD 4215
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Country
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Australia
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Phone
138115
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+61 7056780993
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
138116
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Dale Rowland
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Address
138116
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Griffith University, 1 University Drive, Southport QLD 4215
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Country
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Australia
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Phone
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+61 7056780993
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No 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.
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