Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001017718
Ethics application status
Approved
Date submitted
27/06/2022
Date registered
20/07/2022
Date last updated
20/07/2022
Date data sharing statement initially provided
20/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the feasibility of Orygen Virtual Worlds: a virtual world platform for delivering youth mental health services
Scientific title
A feasibility trial of Orygen Virtual Worlds: a virtual world platform for delivering youth mental health services
Secondary ID [1] 307441 0
None
Universal Trial Number (UTN)
Trial acronym
OVW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Youth mental ill-health 326808 0
Condition category
Condition code
Mental Health 324025 324025 0 0
Anxiety
Mental Health 324026 324026 0 0
Depression
Mental Health 324027 324027 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our research group has developed a purpose-built virtual world platform called ‘Orygen Virtual Worlds’ (OVW) which will be the first virtual world specifically to be used for young people accessing mental health services including for delivery of mental health education, engagement and treatment. Virtual worlds use “avatars” or computer representations of a person to participate in activities or communicate with others. The user accesses a digitally simulated world where they can interact with objects in the environment and thus experience a degree of presence. By meeting with others in this virtual space, social processes can occur which provide a platform for therapeutic benefit through social connection and peer support.

A prototype of the OVW platform has been developed using user centred design principles, alongside a group of 10 - 15 young people and 6 clinicians to ensure it is purpose built to fit their needs. The platform enables users to securely login via invite from a moderator and choose an avatar to visually represent themselves in the virtual world. They are then able to access 'worlds' alongside others also invited to join the session and who are also represented as avatars within the environment. The 3D beach environment can be explored with a mouse and track pad, with system controls enabling voice and text chat with all or select users (under the control of moderators). Screens within the environment can be controlled by moderators to show images, PDFs and videos, and act as a 'white board' which can be edited by users. Users can play games in the virtual environment and specific features enable group discussions (e.g. passing a ball between users whilst sitting around a campfire, a spin wheel of programmable questions to facilitate discussion on particular topics). Teaching and gamification features support therapeutic learning. For example, waves on the beach are used to guide breathing and mindfulness exercises. Users are only allowed to access the world during therapy sessions via a secure invite link.

The aim of the current trial is to evaluate the feasibility, acceptability and usefulness of the platform for delivering standard treatments (individual, group and peer therapy). As such, three therapy modalities were chosen representing common service delivery modes within youth mental health services. Specific interventions were then co-designed with service providers at Orygen, an Australian youth mental health service based in Melbourne. In this trial, participants will receive only one of the treatments described however the focus of the trial is to evaluate the platform as a whole therefore outcomes will be pooled across treatment arms to determine feasibility and acceptability. As the aim of this trial is to test the feasibility and acceptability of this platform for differing different types of treatments, the treatments themselves are not being compared directly but rather the overall feasibility of the platform for delivering each of the interventions.

The details of the different treatment arms are as follows:

Individual intervention
A 8 session (1-hour per session, approximately weekly) intervention consisting of skills-based, psychological one-on-one treatment delivered by a registered psychologist, focusing on improving skills in emotion regulation and distress tolerance based on concepts derived from Acceptance and Commitment Therapy (ACT), Dialectical Behaviour Therapy (DBT) and Behavioural Activation (BA). These interventions are typically employed within Orygen Specialist Services, have a strong evidence base in youth populations (Orygen Evidence Summary, 2018), and were endorsed by both clinicians and young people as being suitable for the current research and relevant to young people’s mental health needs at the current time. ACT and DBT presume that unhelpful/harmful behaviours result from attempts to avoid or suppress unpleasant thoughts, feelings, or bodily sensations (maladaptive coping). When effective, these treatments help individuals to shift their distress responses to adaptive coping activities. Treatment will focus on the acquisition of four key skills drawn from ACT, DBT and/or BA: a) acceptance and willingness, which directly teaches the art of “doing nothing” in the face of negative affect (rather than trying to rid oneself of it through some impulsive action); b) cognitive defusion, which teaches separation between self and ongoing thought processes; c) self-soothing/”healthy distraction” techniques, which give healthy alternatives for calming oneself during the peak of affective distress; and d) mindfulness and relaxation, which teaches the art of coming into the present moment to assist with managing feelings of tension and discomfort. In particular, session one will focus on building engagement and rapport between the therapist and participant, and involve individual avatar customisation, a tour of OVW and an overview of treatment goals and rationale. Sessions two to five will focus specifically on skills training, making use of features within the virtual world such as mindful observation of trees and waves in the ocean. At the conclusion of each session participants will be encouraged to practice the newly-learned skill/s between sessions to promote generalisation of skills acquired. The final session (session six) will provide a review previously taught skills in participants ‘toolbox’ and conclusion.

Group intervention
An 8-session (1-hour per session, approximately weekly) group intervention adapted from an existing manualised group-based program currently being delivered through Orygen’s Specialist Services, Psychosocial Group Program called ‘Relate’. This intervention was selected on the basis of recommendations from clinicians within the Psychosocial Group Program where this intervention is currently being implemented and evaluated, and was endorsed by both clinicians outside this program and young people as being suitable for the current research and relevant to young people’s mental health needs at the current time. The content of the Relate-OVW group will be adapted from the original manual and based on consultation with the original Relate program designers and translatability to the virtual world environment. Group discussion and activities are facilitated by a therapist and focus on topics related to social challenges experienced by young people attending the clinic, and are designed to simultaneously focus on effectiveness in interpersonal relationships (including the development of social skills) while also providing a positive relational experience, leaving participants feeling accepted and empowered. This includes activities such as spinning a wheel which lands on a group discussion topic (e.g. how mood affects social interactions). The Relate-OVW group will be offered as a closed group (e.g., no new group members after session with up to 8 group members plus one facilitator.

Peer support intervention
A 6 session (1-1.5 hours per session, approximately weekly) peer support intervention for young people with experiences of psychosis. This intervention was selected by the lead peer worker (in collaboration with the lead investigators) on the OVW project in consultation with Orygen Peer Work specialists (including 6 peer workers), and was endorsed by both clinicians and young people as being suitable for the current research and relevant to young people’s mental health needs at the current time. Discussion and activities aim to address subjective distress, model social behaviours through upward comparisons, build a positive collective identity and encourage acceptance through the sharing of experiences. The aims and focus of the group will be guided by the principles of Intentional Peer Support (IPS; Mead, 2015), which is an established and widely adopted model for peer support used throughout Orygen services (Fava et al, 2020). Specifically, the three governing principles of IPS are learning instead of helping, building relationships and fostering hope in place of fear. In line with this, the overall aim will be to empower participants and instil hope for the future. The group will also aim to improve social connectedness amongst the participants. Sessions will be semi-structured and peer-led, with the opportunity for members to contribute topics and content they wish to explore with the wider group. Activities will include reflective exercises on relevant lived experiences, guidance seeking, interpersonal learning, psychoeducation and self-management strategies. The peer group will be offered as a closed group (e.g., no new group members after session 1) with up to 8 group members plus 2 peer facilitators.
Intervention code [1] 323890 0
Behaviour
Comparator / control treatment
The aims of this trial are to evaluate the feasibility and acceptability of the OVW platform as a whole, therefore whilst there are three different treatment modalities being tested within the platform, these are not being compared to determine relative efficacy. Rather, the results from each arm will be combined to provide an overall evaluation, not separately to evaluate each individually. Therefore, no comparator was deemed appropriate.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331816 0
Recruitment and consent rates via audit of study enrolment and consent logs
Timepoint [1] 331816 0
8 weeks post intervention
Primary outcome [2] 331817 0
Attendance rates of assessments and sessions via audit of attendance logs
Timepoint [2] 331817 0
8 weeks post baseline
Primary outcome [3] 331859 0
Drop out rates via audit of session attendance logs
Timepoint [3] 331859 0
8 weeks post baseline
Secondary outcome [1] 411265 0
Patient Health Questionnaire - 8 items
Timepoint [1] 411265 0
Baseline and 8 weeks post baseline
Secondary outcome [2] 411266 0
General Anxiety Disorder-7
Timepoint [2] 411266 0
Baseline and 8 weeks post baseline
Secondary outcome [3] 411267 0
Kessler Psychological Distress Scale (K10)
Timepoint [3] 411267 0
Baseline and 8 weeks post baseline
Secondary outcome [4] 411268 0
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Timepoint [4] 411268 0
Baseline and 8 weeks post baseline
Secondary outcome [5] 411269 0
Distress Tolerance Scale (DTS) - individual intervention only
Timepoint [5] 411269 0
Baseline and 8 weeks post baseline
Secondary outcome [6] 411270 0
Social Connectedness Scale (SCS) - group and peer intervention only
Timepoint [6] 411270 0
Baseline and 8 weeks post baseline
Secondary outcome [7] 411271 0
UCLA Loneliness Scale (ULS-8) - group and peer intervention only
Timepoint [7] 411271 0
Baseline and 8 weeks post baseline
Secondary outcome [8] 411272 0
Recovery Assessment Scale - Revised (RAS-R) - peer intervention only
Timepoint [8] 411272 0
Baseline and 8 weeks post baseline
Secondary outcome [9] 411273 0
System Usability Scale (SUS)
Timepoint [9] 411273 0
8 weeks post baseline
Secondary outcome [10] 411274 0
AttrakDiff Questionnaire (user experience)
Timepoint [10] 411274 0
8 weeks post baseline
Secondary outcome [11] 411275 0
Purpose built self-report acceptability and usability questionnaire (reported descriptively for each item) which will be combined to form a composite outcome measure to indicate overall acceptability
Timepoint [11] 411275 0
8 weeks post baseline
Secondary outcome [12] 411276 0
Working Alliance Inventory - Short Revised (WAI-SR)
Timepoint [12] 411276 0
8 weeks post baseline
Secondary outcome [13] 411277 0
ITC-Sense of Presence Inventory (ITC-SOPI)
Timepoint [13] 411277 0
8 weeks post baseline
Secondary outcome [14] 411278 0
System usage data - logins, session length, feature usage rates - assessed via in-app analytics database
Timepoint [14] 411278 0
Continuous (measured during each intervention session)
Secondary outcome [15] 411279 0
Qualitative interview of intervention experiences through semi-structured one-on-one interviews with a member of the research team
Timepoint [15] 411279 0
8 weeks post baseline

Eligibility
Key inclusion criteria
1) Current client of one of Orygen specialist services (EPPIC, PACE, HYPE, Mood Clinic)
2) Aged 16-25 years (inclusive)
3) Sufficient written and spoken English language ability to participate meaningfully
4) Capacity to provide informed consent
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Clients who are currently residing in an inpatient facility or hospital in the home
2) Clients in an acute psychotic mental state or high risk for suicide or self harm, as judged by their treating clinician
3) Inability to provide informed consent as judged by treating clinician

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a parallel single group non-randomised trial in which participants will receive either an individual, group or peer led intervention via Orygen Virtual Worlds. Allocation will be determined by the service of origin and case manager discretion (i.e. individual intervention for participants originating from a mood disorders clinic, group intervention for participants originating from a psychosocial recovery clinic, peer led intervention for participants originating from an early psychosis clinic)
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The primary outcomes of this study will be reported descriptively as summary statistics, including means and standard deviations (or equivalent) of feasibility and acceptability measures for each group. Pre - post changes in mental health measures will be conducted within each group using paired samples t-tests with associated p-values and effect sizes with confidence intervals for mean group differences (Cohen's d effect sizes). Qualitative interviews will be analysed using thematic analysis following the widely accepted Braun and Clarke method (Braun & Clarke, 2006).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/07/2022
Actual
Date of last participant enrolment
Anticipated
1/11/2022
Actual
Date of last data collection
Anticipated
27/12/2022
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22634 0
Orygen Youth Health - Parkville - Parkville
Recruitment postcode(s) [1] 37908 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 311712 0
Government body
Name [1] 311712 0
NHMRC Ideas Grant
Country [1] 311712 0
Australia
Primary sponsor type
University
Name
Orygen, University of Melbourne
Address
35 Poplar Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 313169 0
None
Name [1] 313169 0
Address [1] 313169 0
Country [1] 313169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311163 0
Melbourne Health HREC
Ethics committee address [1] 311163 0
Ethics committee country [1] 311163 0
Australia
Date submitted for ethics approval [1] 311163 0
11/01/2022
Approval date [1] 311163 0
30/06/2022
Ethics approval number [1] 311163 0
HREC/81589/MH-2022

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

Contacts
Principal investigator
Name 120170 0
Prof Andrew Thompson
Address 120170 0
Orygen
35 Poplar Rd
Parkville VIC 3052
Country 120170 0
Australia
Phone 120170 0
+61457756565
Fax 120170 0
Email 120170 0
andrew.thompson@orygen.org.au
Contact person for public queries
Name 120171 0
Carli Ellinghaus
Address 120171 0
Orygen
35 Poplar Rd
Parkville VIC 3052
Country 120171 0
Australia
Phone 120171 0
+61457700250
Fax 120171 0
Email 120171 0
Carli.Ellinghaus@orygen.org.au
Contact person for scientific queries
Name 120172 0
Imogen Bell
Address 120172 0
Orygen
35 Poplar Rd
Parkville VIC 3052
Country 120172 0
Australia
Phone 120172 0
+61430156222
Fax 120172 0
Email 120172 0
imogen.bell@orygen.org.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?
At the discretion the principle investigator
When will data be available (start and end dates)?
Once the study is completed (post Jan 2023) and will be available indefinitely
Available to whom?
At the discretion the principle investigator
Available for what types of analyses?
At the discretion the principle investigator
How or where can data be obtained?
On request to the scientific contact for this study listed under 'contacts' in this form


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.