Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000703808
Ethics application status
Approved
Date submitted
14/04/2021
Date registered
8/06/2021
Date last updated
10/01/2023
Date data sharing statement initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Role-playing group intervention as adjunct to treatment-as-usual in a community mental-health setting
Scientific title
Treatment principles embedded in a table-top role-playing game: impact on treatment efficacy and treatment outcomes in a community mental-health setting
Secondary ID [1] 303943 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social anxiety 321540 0
complex trauma 321541 0
Condition category
Condition code
Mental Health 319289 319289 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current project aims to assess the efficacy of using a table-top role-playing game in a group setting as a means of improving treatment outcomes in a community mental health setting. All clients will continue to receive treatment-as-usual (which can include peer support groups, case management, psychiatrist reviews and medication) during the intervention. Unfortunately, it is not possible to collect data from all of these treatment-as-usual interventions because participants participate fluidly and inconsistently in various aspects of the programmes, as is common in a community mental health setting.

During the intervention, clients will play the popular table-top game “Dungeons and Dragons” in groups of eight, which requires them to take on the role of a character and work collaboratively with other characters to solve problems and achieve goals. The clinical psychologist who leads the game ensures that therapeutic principles related to CBT, unhealthy schemas and psychoeducation are embedded in the game as learning experiences.

Those in the experimental group will receive the group intervention across eight weeks (8 sessions, each session two hours long). The sessions will take place in a group room, at the community mental health facility where clients regularly attend. In groups of eight, the clients will play a popular table-top game of Dungeons and Dragons that has been infused with CBT and mindfulness- based concepts. They will role play a character in a fictional world and will be required to work together with other characters to solve problems and overcome obstacles. The clients will roleplay social interactions that will require them to demonstrate effective social skills to achieve their goals. Each client decides the actions that their character will take in the game and then use dice to see if they are successful. The game will include psychoeducation about mental health issues and exploration of personal strengths and weaknesses. Each client will project aspects of their personalities into the character they create. This allows for a safe platform for clients to explore psychological issues. The game will allow for two types of social anxiety exposure. The first is in-person exposure to other clients in the room. The second is in-game exposure as they roleplay social interactions with other characters. The clinical psychologist leading the game will ensure that all characters are involved in the story line, thus ensuring active participation by all clients. Drop out rates will be monitored.
Intervention code [1] 320254 0
Treatment: Other
Comparator / control treatment
This project is a quasi-randomised waitlist-controlled trial. Sequential enrolment of clients to either the experimental or wait-list group will be followed such that the first eight clients will receive the intervention and the next eight will be assigned to the wait list (for three cycles). Those in the wait-list condition receive treatment-as-usual for 8 weeks before being offered the intervention.
Control group
Active

Outcomes
Primary outcome [1] 327170 0
Changes in self-reported social anxiety (as measured with the Lebowitz Social Anxiety Scale (Liebowitz, 1987)
Timepoint [1] 327170 0
Pre and post measures will be compared between the two groups before and after the experimental group receive the intervention.
Primary outcome [2] 327475 0
Changes in self-reported daily-life interference from past trauma/stressful life events (as measured with the PTSD CheckList – Civilian Version (Blanchard et al., 1996).
Timepoint [2] 327475 0
Pre and post measures will be compared between the two groups before and after the experimental group receive the intervention.
Secondary outcome [1] 394048 0
Changes in self-reported self-esteem as measured by the Multi-dimensional self-esteem inventory scale (O’Brien & Epstein, 1988).
Timepoint [1] 394048 0
Pre and post measures will be compared between the two groups before and after the experimental group receive the intervention.
Secondary outcome [2] 395251 0
Changes in self-reported depressive symptoms as measured by the Beck Depression Inventory (Beck et al., 1996).
Timepoint [2] 395251 0
Pre and post measures will be compared between the two groups before and after the experimental group receive the intervention.

Eligibility
Key inclusion criteria
Inclusion criteria for participants taking part in this study includes:
- Individuals aged at least 18 years old.
- Referral to participating Community Mental Health Service for complex mental health issues
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for those who are not eligible to participate in the study includes:
- Difficulties with understanding English
- Severe cognitive impairment
- Clients deemed as high risk to self or others or acutely psychotic.
- Clients not willing to abstain from the use of alcohol or other drugs during the group sessions

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This project is a quasi-randomised waitlist-controlled trial. Full randomisation would involve recruiting 16 individuals and randomly assigning half of them to the wait-list and half of them to the experimental group, but due to the slow and steady pace of referrals it would not be ethical to make the early referrals wait up to six months for the group intervention (for example if an individual waited three months for the entire cohort of 16 to be recruited and were then assigned to the wait-list condition). As such, sequential enrolment of clients to either the experimental or wait-list group will be followed such that the first eight clients will receive the intervention and the next eight will be assigned to the wait list.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The total sample size for the project is 48 participants – 24 in each group (intervention/wait-list). Although drop-out rates for clinical interventions tend to be high (approx. 25%), a pilot study suggested that dropout rates can be expected to be considerably less - in the 0-15% range. A 15% drop-out rate would mean a total of 40 datasets for the analysis.

A sensitivity analysis conducted in G*Power suggests that with a total of 40 participants (20 in each group), alpha of 0.05, power of 85% (and a conservatively estimated within-subject correlation of 0.7) that an effect size of f=0.18 for the critical interaction between group (intervention/wait-list) and time point (pre/post intervention), would be required. Although we cannot be confident of the expected effect size, we assume that unless the effect size is very small that we will have sufficient power to detect it.

Analysis
The primary outcome measures of this study will be change in self-reported social anxiety and trauma scores for the intervention relative to the wait-list group. Initial analyses will use repeated measures ANOVA to examine whether there is a difference between the two groups in pre/post scores. In addition, secondary analyses will examine whether the groups differ in degree of change in other self-report measures pre-post. Drop-out rates will be monitored for the intervention group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/06/2021
Actual
14/06/2021
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
28/02/2024
Actual
Sample size
Target
40
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308328 0
University
Name [1] 308328 0
University of New South Wales
Country [1] 308328 0
Australia
Primary sponsor type
University
Name
UNSW
Address
UNSW Sydney, NSW 2052, Australia
Country
Australia
Secondary sponsor category [1] 309145 0
None
Name [1] 309145 0
Address [1] 309145 0
Country [1] 309145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308304 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 308304 0
Ethics committee country [1] 308304 0
Australia
Date submitted for ethics approval [1] 308304 0
23/03/2021
Approval date [1] 308304 0
16/04/2021
Ethics approval number [1] 308304 0
HC210156

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

Contacts
Principal investigator
Name 110234 0
Dr Poppy Watson
Address 110234 0
School of Psychology, UNSW Sydney, NSW 2052, Australia.
Country 110234 0
Australia
Phone 110234 0
+610293853828
Fax 110234 0
Email 110234 0
[email protected]
Contact person for public queries
Name 110235 0
Poppy Watson
Address 110235 0
School of Psychology, UNSW Sydney, NSW 2052, Australia.
Country 110235 0
Australia
Phone 110235 0
+610293853828
Fax 110235 0
Email 110235 0
[email protected]
Contact person for scientific queries
Name 110236 0
Poppy Watson
Address 110236 0
School of Psychology, UNSW Sydney, NSW 2052, Australia.
Country 110236 0
Australia
Phone 110236 0
+610293853828
Fax 110236 0
Email 110236 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 participant data, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Will be available on a public data repository, available to everyone.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Via the open science framework website. Link will be made available in the published manuscript


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.