None listed
Conditions
Brief summary
Our study will evaluate the feasibility of active Virtual Reality gaming (AVRG) in increasing engagement and adherence to physical activity (PA) in young men with mild to moderate depression. This randomised controlled trial is an important first step before undertaking larger trials to better understand factors affecting recruitment, engagement and adherence, retention and safety, as well as effects on depressive symptoms and lifestyle behaviour. The scalability of VR gaming in the community, means potential for increased access and reach, particularly during The COVID-19 pandemic has increased in social isolation and decreased access to fitness facilities, highlighting the need for accessible and acceptable options for physical activity participation. The scalability and popularity of AVRG among young males is a strength of potentially using this as a depression treatment for this hard-to-reach population with the lowest help-seeking rates but the highest incidence for mental illnesses.
Interventions
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.
T
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.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 29 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed