Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000892617
Ethics application status
Approved
Date submitted
4/08/2023
Date registered
21/08/2023
Date last updated
25/01/2024
Date data sharing statement initially provided
21/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Chronic Insomnia Treatment Using Virtual Reality (VR) Delivered Mindfulness
Scientific title
Feasibility of at-home virtual reality delivered mindfulness for insomnia and related symptoms in a community sample with self-reported chronic insomnia.
Secondary ID [1] 310298 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
VRmind
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic insomnia 331000 0
Condition category
Condition code
Mental Health 327813 327813 0 0
Other mental health disorders
Neurological 327910 327910 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326680 0
Behaviour
Intervention code [2] 326681 0
Treatment: Devices
Comparator / control treatment
A control group will receive computer-screen-delivered mindfulness (2Dmind).
The mindfulness content is the same in both conditions.

Participants in the control group (2Dmind), will use their own computer or phone and access the same mindfulness content online.

Participants randomised to 2Dmind will be given the option to complete an additional 4 weeks of VRmind at the end of the study.
Control group
Active

Outcomes
Primary outcome [1] 335661 0
Completion
% mindfulness sessions completed in 4 weeks of treatment
Participant mindfulness practice log.
Timepoint [1] 335661 0
At the conclusion of 4 weeks of treatment from the completion of baseline measures.
Secondary outcome [1] 425124 0
Treatment Satisfaction: Questionnaire
Treatment satisfaction is measured using a modified/adapted version of the Multi-Dimensional Treatment Satisfaction Measure (MDTSM) for insomnia.

The MDTSM consists of 11 subscales assessing the treatment process and outcome attributes. Each subscale has 1-8 items. Each question except the Discomfort subscale is rated on a five-point scale ranging from zero (“Not at all”) to 4 (“Very much”). The 33-item instrument was developed for behavioural interventions and is designed to provide a comprehensive set of treatment attributes.

Participant mean scores across all 33 ratings are calculated, resulting in a score ranging from zero ("Not at all satisfied") to 4 ("Very satisfied").
Timepoint [1] 425124 0
Within 2 days after the final treatment session.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

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 a computer.
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) with a preset 2, 1 block sequence (intervention /control) . Secure randomisation will be done automatically using an online randomisation system. The system will assign a unique participant number in sequential, ascending chronological order.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics are the main analytic strategy. Statistical analyses will be focused on collecting data on feasibility and acceptability. Analysis will focus on collecting preliminary data on clinical significance (i.e., effect size) instead of making formal inference (i.e., p-value).

Primary hypothesis is that at-home VR-delivered mindfulness insomnia treatment will achieve a treatment session completion rate of at least 50% or a treatment completion rate of > 4 of the 8 mindfulness sessions at the end of the 4 weeks of treatment.

VR-delivered insomnia treatment will be acceptable (MDTSM) and have no serious worsening of symptom measures. A detailed evaluation of the treatment satisfaction scores is planned and a greater focus on cases with negative responses for treatment satisfaction is planned. Thematic analysis of responses to the end of the study evaluation is planned.

Recruitment, enrolment, and randomisation results will be presented using a Consolidated Standards of Reporting Trials (CONSORT) table.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2024
Actual
Date of last participant enrolment
Anticipated
2/12/2024
Actual
Date of last data collection
Anticipated
6/01/2025
Actual
Sample size
Target
43
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 41046 0
2250 - Gosford
Recruitment postcode(s) [2] 41045 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 314510 0
University
Name [1] 314510 0
University of Newascastle
Country [1] 314510 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 316461 0
None
Name [1] 316461 0
Address [1] 316461 0
Country [1] 316461 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313553 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 313553 0
Human Research Ethics Administration
Research & Innovation Services
Research Integrity Unit
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 313553 0
Australia
Date submitted for ethics approval [1] 313553 0
08/08/2023
Approval date [1] 313553 0
18/10/2023
Ethics approval number [1] 313553 0
H-2023-0313

Summary
Brief summary
This feasibility study will Virtual Reality (VR) delivered mindfulness as a treatment for chronic insomnia. The experimental treatment is VR-delivered mindfulness ("VRmind").

The investigators will demonstrate the feasibility of conducting a trial of at-home VRmind for people with chronic insomnia. Participants will be randomised to receiced 4 weeks of twice weekly mindfulness sessions delivered using a VR-headset (VRmind) or a or a computer-screen ("2Dmind"). At the end of treatment, participants will provide feedback by completing a satisfaction questionnaire.

To complete the weekly at-home mindfulness sessions participants in the VRmind group will be provided with a VR-headset by the study and details to access the weekly mindfulness content. Participants in the 2Dmind group will be given online access to the same mindfulness content be using their own computer/phone. Participants randomized to 2Dmind will be the option to complete an additional 4 weeks of VRmind at the end of the study.
Trial website
www.insomniaresearch.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128522 0
A/Prof Lisa Lampe
Address 128522 0
School of Medicine and Public Health
The University of Newcastle (UON)
University Drive
Callaghan NSW 2308

Country 128522 0
Australia
Phone 128522 0
+61 2 4033 9631
Fax 128522 0
Email 128522 0
lisa.lampe@newcastle.edu.au
Contact person for public queries
Name 128523 0
Mrs Rita Hitching
Address 128523 0
School of Medicine and Public Health
The University of Newcastle (UON)
University Drive
Callaghan NSW 2308

Country 128523 0
Australia
Phone 128523 0
+61 2 4348 4689
Fax 128523 0
Email 128523 0
c3393362@uon.edu.au
Contact person for scientific queries
Name 128524 0
Mrs Rita Hitching
Address 128524 0
School of Medicine and Public Health
The University of Newcastle (UON)
University Drive
Callaghan NSW 2308
Country 128524 0
Australia
Phone 128524 0
+61 2 4348 4689
Fax 128524 0
Email 128524 0
c3393362@uon.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified electronic data sets of outcomes will be made available.
When will data be available (start and end dates)?
The study data will be available following all analyses.
Available to whom?
Upon written request to the corresponding author of published manuscripts that arise from this project
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Secure data transfer and signed data access agreement by contacting the Coordinating Principal Investigator: Lisa.Lampe@newcastle.edu.au


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23860Ethical approval    386366-(Uploaded-07-06-2024-12-19-04)-Approval Ethics Variation UoN May 2024.pdf

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.