Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001372976
Ethics application status
Approved
Date submitted
19/10/2020
Date registered
22/12/2020
Date last updated
1/07/2022
Date data sharing statement initially provided
22/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised feasibility study assessing the effect of an active virtual reality gaming intervention on physical activity and mood in young men with mild to moderate depression.
Scientific title
A randomised feasibility study assessing the effect of an active virtual reality gaming intervention on physical activity and mood in young men with mild to moderate depression as compared to a wait list control.
Secondary ID [1] 302553 0
None
Universal Trial Number (UTN)
U1111-1259-8006
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 319430 0
Condition category
Condition code
Mental Health 317398 317398 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial group will undertake baseline measures and then commence an 8-week program of completing a recommended minimum 3 x 30 minutes per week of participation in Active Virtual Reality Gaming (AVRG) of moderate to vigorous intensity.

Study duration:
Total study duration is 13 weeks for the AVRG intervention;
- 1 week prior to trial entry to perform baseline measures, deliver equipment to participants and aid in set up and use,
- 8 weeks of active treatment and
- 4 weeks of follow-up.

The device used in this trial will be the Oculus Quest 2 (released in October 2020) all-in-one, wireless VR headset. This device required no additional console and has insight tracking in which built-in sensors translate movements into VR and provide room-scale tracking. It also includes hand-held touch controllers which allow hands and gestures to appear in VR with realistic precision.
We will be using the 64GB version of this device and a Facebook account for sign in and activation. Also included will be the software to participate in three AVR games which have been chosen according to their physical activity ratings as per the Virtual Reality Institute of Health and Exercise:
- Thrill of The Fight; a boxing simulation including training and boxing matches. Rated 8-10 calories per minute, or equivalent to rowing.
- Pistol Whip; a shooting simulation including travelling through various environments, targeting non-realistic humanoids and dodging sites and bullets. Rated 6-8 calories per minute, or equivalent to tennis.
- Beat Sabre/Audio Trip; a rhythm game requiring speed, coordination and accuracy to strike oncoming targets in time with music while evading moving objects. Rated 6-8 calories per minute, or equivalent to tennis.

The baseline and followup measures will be administered remotely, online via the REDcap app and they are all clinically validated assessments.
Participation in the VR gaming will be tracked via the Oculus Quest device and also via participants using the VR Health and Exercise app with a bluetooth heart rate monitor. This data will be downloaded into REDcap. Our recommendation will be for at least 3 x 30 minute sessions per week (in line with minimum national physical activity guidelines for moderate or greater intensity exercise) and adherence will be measured against that.
A four-week follow up survey will include questions on whether they have continued AVRG and/or are doing other physical activity.
Intervention code [1] 318842 0
Lifestyle
Intervention code [2] 318843 0
Behaviour
Intervention code [3] 319105 0
Treatment: Devices
Comparator / control treatment
The wait list group will wait for eight weeks after baseline measures, undergo outcome measures, complete the intervention and then outcome measures again.
The intervention, outcome measures and followup will be identical to the trial group.
Control group
Active

Outcomes
Primary outcome [1] 325433 0
Feasibility - Recruitment rate (interest to participate in the trial, identification of appropriate recruitment strategies and the appropriateness of eligibility criteria). Recruitment rate will be calculated as the number of men who are eligible for randomisation out of those who express interest in the trial. We will assess this via study databases and data from our recruitment partner Healthmatch
Timepoint [1] 325433 0
After 8-week intervention
Primary outcome [2] 325434 0
Feasibility - Engagement & Adherence (compliance with activity). This will be calculated as the number of participants who meet the recommendation for minimum 3 x 30min sessions per week and for how many weeks they achieve this level.
This will be assessed via participant-tracked data from the VR Health and Exercise app downloaded to RECcap.
Timepoint [2] 325434 0
8-weeks post intervention commencement
Primary outcome [3] 325435 0
Feasibility - Retention – dropout rates. Retention will be calculated as the number of participants to complete both baseline and follow-up outcome measures. This will be assessed from study databases in REDcapp clinical trial software.
Timepoint [3] 325435 0
8-weeks post intervention commencement
Secondary outcome [1] 387945 0
Depressive symptoms - assessed using PHQ-9 (minimal, mild, moderate, moderately-severe, severe depression)
Timepoint [1] 387945 0
At 4 and 8 weeks post intervention commencement
Secondary outcome [2] 387946 0
Motivation - assessed on EMI-2 (Exercise Motivation Inventory)
Timepoint [2] 387946 0
8-weeks post intervention commencement
Secondary outcome [3] 387947 0
Quality of life - SF36
Timepoint [3] 387947 0
8-weeks post intervention commencement
Secondary outcome [4] 387948 0
Sleep - PSQI (Pittsburgh Sleep Quality Index)
Timepoint [4] 387948 0
8-weeks post intervention commencement
Secondary outcome [5] 387949 0
Physical Activity - IPAQ (International Physical Activity Questionnaire)
Timepoint [5] 387949 0
8-weeks post intervention commencement
Secondary outcome [6] 387950 0
Readiness to change - We will use a simple one-question previously validated format to evaluate readiness to change physical activity behaviour according to the stages in the Transtheoretical Model.
Timepoint [6] 387950 0
8-weeks post intervention commencement and 4 weeks post intervention completion
Secondary outcome [7] 389066 0
Depression, Stress and Anxiety using the DASS-21 which rates all three as normal, mild, moderate, severe, extremely severe.
Timepoint [7] 389066 0
8-weeks post intervention commencement

Eligibility
Key inclusion criteria
- Males, aged 18-29 years.
- Scoring mild (5-9) to moderate (10-14) for depressive symptoms on the PHQ-9
- Willing and physically able to participate in active VR gaming
- Are sedentary or close to sedentary: up to 30 mins per week of moderate or greater intensity physical activity. This includes incidental activity such as cycling to work.
- No increased in structured exercise or moderate or greater activity planned for within the trial period.
- Has not stopped taking any pharmaceutical medication, complementary medicines or supplements specifically aimed at enhancing mood in the last three months.
- Not currently be taking any pharmaceutical medication, complementary medicines or supplements specifically aimed at enhancing mood (e.g SSRI/SNRI medication, St John’s Wort)
- Not currently undergoing any medical therapy or complementary strategies aimed at enhancing mood (e.g cognitive behavioural therapy).
- Have reliable wifi internet connection, access to a smartphone to for screening and outcome apps, willing to use a Facebook account to log into the Oculus device.
- Have a safe and clear 2 x 2m space at their place of residence in which to operate the gaming device.
- Willing to provide informed consent and adhere to the protocol.
Minimum age
18 Years
Maximum age
29 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Scoring moderately severe (15-19) or severe (20-27) for depressive symptoms on the PHQ-9.
- Providing a positive response to question 9 - “Thoughts that you would be better off dead or of hurting yourself in some way”.
- Providing a positive response to any questions on the Physical Activity Readiness Questionnaire (PAR-Q)16
- Physical issues which may potentially affect safe and fully operational participation in AVR gaming in a standing and moving posture, for example vision or balance issues such as vertigo.
- Diagnosed with photosensitive epilepsy; possible increased seizure risk due to increased eye stimulation and brain affect
- Have an implanted medical device such as a cardiac pacemaker, hearing aid or defibrillator that may be affected by magnets or components that emit radio waves in the headset or controllers.

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 by computer (REDCap clinical trials software)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simpler andomisation using a randomisation table created by computer software (REDCapp)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait list
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline demographics will be reported using descriptive statistics.
As feasibility is our main outcome, engagement and adherence to the program will be explored. We will look for standard mean differences in baseline and endpoint measures to inform both primary and secondary outcomes. Secondary outcomes such as changes in PHQ-9 scores will be reported descriptively with means and confidence intervals, or medians and inter-quartile ranges as appropriate. Given the primarily feasibility nature of the study no between group inferential statistics will be performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2021
Actual
28/05/2021
Date of last participant enrolment
Anticipated
1/04/2021
Actual
9/10/2021
Date of last data collection
Anticipated
31/03/2022
Actual
2/04/2022
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306989 0
University
Name [1] 306989 0
Western Sydney University
Country [1] 306989 0
Australia
Funding source category [2] 306991 0
Commercial sector/Industry
Name [2] 306991 0
Blackmores Institute
Country [2] 306991 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797
PENRITH NSW 2751
Country
Australia
Secondary sponsor category [1] 307554 0
Other Collaborative groups
Name [1] 307554 0
NICM Health Research Institute (via Blackmores Institute Scholarship)
Address [1] 307554 0
Locked Bag 1797
PENRITH NSW 2751
Country [1] 307554 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307122 0
Western Sydney University Human Resdearch Ethics
Ethics committee address [1] 307122 0
Ethics committee country [1] 307122 0
Australia
Date submitted for ethics approval [1] 307122 0
15/10/2020
Approval date [1] 307122 0
27/11/2020
Ethics approval number [1] 307122 0
H14118

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

Contacts
Principal investigator
Name 106106 0
Dr Mike Armour
Address 106106 0
Western Sydney University
Building J, Westmead Campus
Locked Bag 1797
PENRITH NSW 2751
Country 106106 0
Australia
Phone 106106 0
+61 2 9685 4720
Fax 106106 0
Email 106106 0
[email protected]
Contact person for public queries
Name 106107 0
Mike Armour
Address 106107 0
Western Sydney University
Building J, Westmead Campus
Locked Bag 1797
PENRITH NSW 2751
Country 106107 0
Australia
Phone 106107 0
+61 2 9685 4720
Fax 106107 0
Email 106107 0
[email protected]
Contact person for scientific queries
Name 106108 0
Mike Armour
Address 106108 0
Western Sydney University
Building J, Westmead Campus
Locked Bag 1797
PENRITH NSW 2751
Country 106108 0
Australia
Phone 106108 0
+61 2 9685 4720
Fax 106108 0
Email 106108 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication until 15 years post intervention
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal, for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator, Dr Mike Armour ([email protected], +612 9685 4700)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9800Ethical approval  [email protected]
9802Study protocol  [email protected] We intend to submit the study protocol for publica... [More Details]



Results publications and other study-related documents

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