Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000305527
Ethics application status
Approved
Date submitted
23/02/2024
Date registered
22/03/2024
Date last updated
22/03/2024
Date data sharing statement initially provided
22/03/2024
Date results provided
22/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A mindfulness-based, remotely used, virtual reality intervention for university students
Scientific title
Remote Digital Mental Health: A Pilot Randomised Control Trial of a Single Session Mindfulness-based Virtual Reality Intervention
Secondary ID [1] 311597 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 333003 0
psychological distress 333004 0
Condition category
Condition code
Mental Health 329698 329698 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Title:
A one-session, remote mindfulness-based intervention for psychological wellbeing.

Rationale:
The transdiagnostic potential of mindfulness-based VR interventions for anxiety, stress, and depression, has shown promising results (Navarro-Haro et al., 2017; Riva et al., 2021; Seabrook et al., 2020). One randomised control trial conducted by Liszio and colleagues (2018) with a university student sample, found decreases in anxiety and negative affect and increases of positive affect, and this was comparative to the computer-based and control condition.

Materials:
The virtual environments were recorded using a 360-degree VR camera (GoPro Hero) and hosted via YouTube VR. The one-session mindfulness intervention components (i.e., psychoeducational videos with audio) were adapted from Barlow's (2010) trans-diagnostic treatment manual referred to as the unified protocol. The module on emotion recognition, present focussed awareness, and non-judgmental emotional awareness was recorded by a provisionally registered psychologist.

The one-session mindfulness intervention components (i.e., psychoeducational videos with audio) were adapted from Barlow's (2010) trans-diagnostic treatment manual referred to as the unified protocol. The intervention included 2 x 4-minute psychoeducation videos, recorded in a therapy room. Content reflected Barlow's (2010) module on emotion recognition, present focussed awareness, and non-judgmental emotional awareness. The two psychoeducative videos were played consecutively and followed by a brief reflective activity which prompted participants to consolidate content and consider its application in the future. Following this, the virtual therapist narrated a ten-minute guided mindfulness meditation intervention. The audio recording was played in conjunction with a 10-minute recording of a virtual environment of a creek and natural bush land. While viewing the scenery, participants listened to the voice over and focused their attention to their feelings, thoughts, breathing, and the environment. This was consistent across the three active treatment conditions (Arm 1 - virtual reality, Arm 2 - Computer, and Arm 3 - mobile phone), The content of the active treatment components was identical across each treatment condition, with participants in the phone and computer conditions viewing all content as two-dimensional video recordings.. The total duration of the single-session intervention across each condition was between 20 - 30 minutes.

Participants in the virtual reality (VR) condition accessed the mindfulness intervention using the Google Cardboard VR head mounted display (https://arvr.google.com/cardboard/) which was posted to the participants that were randomly allocated to the VR condition. Participants in this condition were required to insert their personal smartphone into the Google Cardboard VR and access the mindfulness intervention by clicking on the links to the Youtube VR videos. Head tracking allowed the participant to visually explore the virtual environments of the intervention.

Participants in the computer, phone, and active control conditions accessed the relevant intervention using either their personal computer or phone. Participants followed the study information prompts to access a link to the intervention landing page (developed using Microsoft Sway) via their preferred web browser. The virtual environments were embedded using YouTubeVR and participants could use their mouse or touchscreen to navigate the virtual environment. Adherence and completion of the intervention was monitored via a Microsoft Teams meeting with the participant and research assistant, website analytics from YouTube VR (VR, computer, and phone conditions) and Microsoft Sway (active control condition), and post-intervention study-specific qualitative data.

Procedure:
The study was granted ethics approval from the associated university’s Human Research Ethics Committee. Participants completed their registration to participate via an online form and were provided with the link to the pre-intervention questionnaire package and consent form through LimeSurvey (Schmitz, 2003). Participants were then randomly allocated to one of the four conditions using a computer-based random sequenced number generator: active control condition (n = 42), computer condition (n = 44), smartphone condition (n = 46), or a virtual reality intervention (n = 39). Those allocated to the VR condition were posted the Google Cardboard VR HMD to an address of their choosing.

Upon completion of the pre-questionnaires, and group allocation, participants selected a time for a virtual meeting with one of the investigators via Microsoft Teams. During the online meeting, participants completed the intervention condition and post intervention questionnaires independently. Although the intervention was unguided, participants were able to contact researchers via the chat or audio functions on Microsoft Teams with any queries or concerns throughout the intervention. Primarily though, participants were left to complete the intervention in an unguided manner and were not therapeutically assisted by researchers. Upon completion of the intervention, participants were directed to the online post intervention questionnaire package. Two to four weeks following participation, participants completed a follow-up online questionnaire that was disseminated via email.
Intervention code [1] 328052 0
Treatment: Other
Comparator / control treatment
Participants in the active control received a similar amount of psychoeducative content and the same number of video recordings as the treatment conditions, however the intervention was on hand-hygiene practices. Content for the control condition was drawn from national (Hand Hygiene Australia ) and international health advice (WHO). Participants followed the study prompts to access the intervention landing page (hosted developed using Microsoft Sway) using their preferred web-browser on their computer.

The duration to complete the intervention (irrespective of active treatment or control conditions) was approximately 20-30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 337483 0
Mindfulness
Timepoint [1] 337483 0
Pre-intervention, post-intervention, and follow-up (at 2-4 weeks post-intervention)
Primary outcome [2] 337484 0
Affect
Timepoint [2] 337484 0
Pre-intervention, post-intervention, and follow-up (at 2-4 weeks post-intervention)
Primary outcome [3] 337485 0
Psychological distress
Timepoint [3] 337485 0
Pre-intervention, post-intervention, and follow-up (at 2-4 weeks post-intervention)
Secondary outcome [1] 432073 0
Digital Mental Health Engagement
Timepoint [1] 432073 0
Pre-intervention, post-intervention, and follow-up (at 2-4 weeks post-intervention)
Secondary outcome [2] 432074 0
Treatment credibility and expectations. This will be assessed as a composite outcome
Timepoint [2] 432074 0
Pre-intervention, post-intervention, and follow-up (at 2-4 weeks post-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
None

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
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed factorial design, with participants allocated to condition (between participants: control, computer, phone, or VR). Completing of primary outcome measures at three time points (within participants: pre, post, 2-4 week follow up).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/05/2021
Date of last participant enrolment
Anticipated
Actual
30/11/2022
Date of last data collection
Anticipated
Actual
27/01/2023
Sample size
Target
153
Accrual to date
Final
171
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315904 0
University
Name [1] 315904 0
Griffith University
Country [1] 315904 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 318051 0
None
Name [1] 318051 0
Address [1] 318051 0
Country [1] 318051 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314752 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 314752 0
Ethics committee country [1] 314752 0
Australia
Date submitted for ethics approval [1] 314752 0
10/03/2021
Approval date [1] 314752 0
28/04/2021
Ethics approval number [1] 314752 0

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

Contacts
Principal investigator
Name 132610 0
Mr Dale Rowland
Address 132610 0
Griffith University, 1 University Drive, Southport QLD 4215
Country 132610 0
Australia
Phone 132610 0
+617056780993
Fax 132610 0
Email 132610 0
[email protected]
Contact person for public queries
Name 132611 0
Dale Rowland
Address 132611 0
Griffith University, 1 University Drive, Southport QLD 4215
Country 132611 0
Australia
Phone 132611 0
+617056780993
Fax 132611 0
Email 132611 0
[email protected]
Contact person for scientific queries
Name 132612 0
Dale Rowland
Address 132612 0
Griffith University, 1 University Drive, Southport QLD 4215
Country 132612 0
Australia
Phone 132612 0
+617056780993
Fax 132612 0
Email 132612 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
A decision has not yet been reached. Awaiting approval from ethics and relevant university research departments. IPD, statistical analysis plan, informed consent etc. will be made available retrospectively following approval.


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.