None listed
Conditions
Brief summary
This study will evaluate the feasibility and acceptability of at-home Virtual Reality (VR) delivered mindfulness as a treatment for insomnia in a community sample with chronic insomnia. The experimental treatment is VR-delivered mindfulness (“VRmind”). Participants will be randomised to either VR-delivered mindfulness (VRmind) or to watching relaxing nature-based videos and music (Control) using a smart device (e.g., phone, tablet, computer). Participants will be provided with all necessary VR equipment and online video access to complete the at-home sessions. Participants complete symptom-based measures (e.g., ISI, PSQI, MAAS) at baseline, week 4, and follow-up (week 8). At the end of treatment participants complete the MDTSM and provide qualitative feedback via a semi-structured interview. Participants randomized to the Control group, will be offered the option to complete 4 weeks of at-home VR-delivered mindfulness at the end of the study.
Interventions
Name
At-home Virtual Reality delivered mindfulness for the treatment of chronic insomnia.
Justification
Despite advances in the treatment of insomnia, including efforts to broaden access to first-line psychological treatments through Apps and online training, meaningful reductions in symptom severity or improvements to the quality of life of Australians have not materialised. Chronic insomnia remains highly prevalent and accompanied by considerable societal, economic, and disease burden.
To ad
Name At-home Virtual Reality delivered mindfulness for the treatment of chronic insomnia. Justification Despite advances in the treatment of insomnia, including efforts to broaden access to first-line psychological treatments through Apps and online training, meaningful reductions in symptom severity or improvements to the quality of life of Australians have not materialised. Chronic insomnia remains highly prevalent and accompanied by considerable societal, economic, and disease burden. To address the lack of innovation in delivering available evidence-based treatment for chronic insomnia and emerging evidence supporting the use of virtual reality to deliver mindfulness in the treatment of conditions where insomnia is common, in a community sample of adults with self-reported chronic insomnia. Type of Intervention Behaviour, interactive, device. Setting At-home Location Within the Hunter New England and Central Coast regions of NSW, Australia Duration 2x (20-minute) weekly at-home mindfulness sessions, over 4 consecutive weeks. Treatment The VR-delivered mindfulness application is commercially available. The mindfulness sessions are set against a backdrop of different visuals, some naturalistic others entirely computer generated. Instructions for the accompanying mindfulness and paced breathing activities are provided using audio narration. Activities Participants will be asked to complete a minimum of 2 virtual reality (VR) delivered mindfulness sessions per week, a minimum of 2 days apart. Each mindfulness session is approximately 20 minutes. Participants select a time of their choosing to complete the mindfulness sessions but are encouraged to complete all sessions at a similar time of day. Participants will be asked to keep a mindfulness practice log and receive reminders to complete their mindfulness sessions. Device Participants will be provided with online access to the mindfulness content and a Meta Quest 2 VR headset for the duration of the study to complete the mindfulness sessions.
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 - 80 years. 2. Proficient in reading, writing, and communicating in English. 3. Insomnia symptoms (difficulty falling asleep, staying asleep, or waking too early) at least 3 times per week for a minimum of 3 months and an Insomnia Severity Index (ISI) score greater than or equal to 10. 4. Able to attend an in-person baseline appointment. 5. Be willing to be randomised to VR or 2D (computer) delivered mindfulness. 6. Willing to use a VR headset to complete the twice weekly VR-delivered mindfulness sessions if randomised to the VR condition.
Exclusion criteria
1. Unable to move the head in all directions and wear a VR head-mounted display 2. Vertigo or related conditions (e.g., Meniere's disease) 3. Unstable medication regimen, defined as having commenced, discontinued, or changed medication or its dosage within < 2 weeks 4. Substance use at a level or of a type likely to cause significant impairment, defined as a high score on the Alcohol Use Disorders Identification Test (AUDIT-C). 5. Admission to a psychiatric hospital within the last 12 months 6. Diagnosed severe psychiatric illness (e.g., Schizophrenia) 7. Thoughts of self-harm in the last 2 weeks, defined as Patient Health Questionnaire (PHQ -9) score >1 on question 9 8. Sleep disorder (other than insomnia) due to neurological or medical cause (e.g., parasomnias, OSA, narcolepsy, seizure) or prescribed sleep aid (e.g., CPAP)
Outcome results
None listed