Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000296437
Ethics application status
Approved
Date submitted
27/03/2025
Date registered
14/04/2025
Date last updated
14/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Therapeutic Dragon Taming: the effectiveness of a therapeutically applied Dungeons and Dragons group program in a community mental health setting - a randomised controlled trial.
Scientific title
Therapeutic Dragon Taming: the effectiveness of a therapeutically applied Dungeons and Dragons group program in a community mental health setting - a randomised controlled trial.
Secondary ID [1] 314056 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 336803 0
anxiety 336802 0
complex trauma 337017 0
Condition category
Condition code
Mental Health 333468 333468 0 0
Depression
Mental Health 333296 333296 0 0
Psychosis and personality disorders
Mental Health 333295 333295 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 8-week intervention consists of a game of Dungeons and Dragons that was specifically adapted for maximum therapeutic benefit and has elements of cognitive behavioural therapy infused into the game. There are 3 main means that elements of CBT are delivered during the game sessions.
1) Psychoeducation and social skills training are embedded into the storyline. For example, participants will practice communicating with specially designed characters and will be given guidance and feedback regarding their interactions.
2) The game structure will mimic elements of exposure in social anxiety treatment. Subjective Units of Discomfort Scale (SUDS) ratings will be used before, during and after each game to demonstrate to participants how their distress levels will drop over the time that they have participated in the game.
3) Teachable moments will be used throughout the game sessions. Participants will be asked to reflect on what other characters might be thinking and feeling, and to notice how they are behaving. This allows for further exploration of CBT principles.

The structure of the overall program is as follows:

Dungeons and Dragons Intervention group

Session 1 includes introductions, safety planning, discussion of group rules, psychoeducation about unhelpful thoughts, a full explanation of how role-playing games work and what to expect in the group. The participants will then practice gameplay so that they are more familiar with the structure of the game.

Sessions 2-7 include the core content of the group with the following structure:

- First 10-20 mins- Introductions, safety measures, SUDS ratings, relevant feedback and information provided.
- The next 1-1.5 hours- game play with the core content of the group.
- Final 15-30mins- feedback, psychoeducation and de-roling. De-roling refers to a process whereby it is ensured that participants have completing shifted out of their fictional character and back into their everyday life.

Session 8 includes the final role play encounter, participants strengths are reflected to them and certificates are distributed. Participants will complete outcome measures and a satisfaction survey. Participants are asked for verbal feedback about their participation in the group and they are provided with information about how to play Dungeons and Dragons in a social context.

The PI will be the Primary Facilitator for all the Dungeons and Dragons intervention groups. This role is termed “Primary Facilitator” as the role requires the individual to both run the game and facilitate a clinical intervention group. A co-facilitator will be chosen from a pool of eligible mental health clinicians. The role of co-facilitator will be as follows:
- Play their own character alongside the participants so they can provide in-game assistance to the participants.
- Assist the primary facilitator with providing important observations of the engagement and mental state of the participants.
- Be available to assist a participant if they needed to step out of the game for any reason which allows the primary facilitator to continue running the group.

Each intervention group will be made up of the following:
a) 6 research participants
b) 1 primary facilitator
c) 1 co-facilitator
Intervention code [1] 330636 0
Treatment: Other
Comparator / control treatment
This active control group will experience the social aspects of a focused leisure activity in the presence of others but will not experience the psychoeducation and principles of CBT that are embedded in the role-playing board game intervention.

Session 1 includes introductions, safety planning and discussion of group rules/expectations. The participants will choose board games to play from a selection provided. The board games used will be commonly played and commercially available board games that require collaboration. Examples of this include Monopoly, Pictionary and Cranium. They will replicate the experience of playing board games in a social setting (hence social board game group). Participants will be allowed to play the games for up to a total of 2 hours, including the introductions and safety planning.

Sessions 2-8 includes a brief check-in with participants at the start and safety planning when needed. As for session 1, they will be offered board games to play from the selection available for up to a total of 2 hours including the brief check in at the start.

The PI will be the Primary Facilitator for all the board game control groups. A co-facilitator will be chosen from a pool of eligible mental health clinicians. The role of co-facilitator will be as follows:
- Play board games with the participants.
- Assist the primary facilitator with providing important observations of the engagement and mental state of the participants.
- Be available to assist a participant if they needed to step out of the game for any reason which allows the primary facilitator to continue running the group.

Each control group will be made up of the following:

d) 6 research participants
e) 1 primary facilitator
f) 1 co-facilitator
Control group
Active

Outcomes
Primary outcome [1] 340872 0
Change in self-reported Social Anxiety
Timepoint [1] 340872 0
Baseline and immediately at the end of the week 8 group session.
Secondary outcome [1] 445311 0
Change in self-reported symptoms of depression
Timepoint [1] 445311 0
Baseline and immediately at the end of the week 8 group session.
Secondary outcome [2] 445312 0
Change in self-reported symptoms of trauma
Timepoint [2] 445312 0
Baseline and immediately at the end of the week 8 group session.
Secondary outcome [3] 445313 0
Change in self-reported self-esteem
Timepoint [3] 445313 0
Baseline and immediately at the end of the week 8 group session.

Eligibility
Key inclusion criteria
1) Participants will have an open encounter with an eligible community mental health service in SLHD.
2) Be aged between 16-65 yrs old.
3) Capable of providing informed consent.
5) Parental/Guardian consent in the case of 16 and 17-year-olds.
6) A basic level of English comprehension.
7) Participants will be required to own a ‘smart’ mobile phone or computer with Wi-Fi / internet connection.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Participants experiencing psychiatric symptoms that constitute an acute level of risk at the time of referral.
2) Unable or unwilling to be respectful in a group setting.
3) Unable or unwilling to commit to 8 consecutive weeks of attendance.
4) Unable or unwilling to refrain from using alcohol and/or substances prior to participating in the group.
5) A cognitive deficit that would interfere with the participant’s ability to participate in the group.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table generated by Matlab
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
A linear mixed model approach will be used to examine significant changes in anxiety scores pre-post as a function of intervention/control group assignment. Individual participants (first level analysis) will be nested in weekly participation groups (second level analysis). Variables at the first level will include age, gender, time (pre/post), intervention group (intervention or control) and the interaction between these two variables. The nesting of participants within specific weekly participation groups will be specified through a random effect for the group-level structure (Level 2).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
28/04/2028
Actual
Date of last data collection
Anticipated
28/07/2029
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318562 0
Government body
Name [1] 318562 0
NSW health
Country [1] 318562 0
Australia
Primary sponsor type
Government body
Name
NSW Health
Address
Country
Australia
Secondary sponsor category [1] 320961 0
University
Name [1] 320961 0
University of Technology Sydney
Address [1] 320961 0
Country [1] 320961 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317161 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 317161 0
Ethics committee country [1] 317161 0
Australia
Date submitted for ethics approval [1] 317161 0
23/09/2024
Approval date [1] 317161 0
13/02/2025
Ethics approval number [1] 317161 0
2024/PID02278

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

Contacts
Principal investigator
Name 140210 0
Dr Poppy Watson
Address 140210 0
University of Technology Sydney, 100 Broadway, Sydney, NSW 2007
Country 140210 0
Australia
Phone 140210 0
+61 435755721
Fax 140210 0
Email 140210 0
[email protected]
Contact person for public queries
Name 140211 0
Poppy Watson
Address 140211 0
University of Technology Sydney, 100 Broadway, Sydney, NSW 2007
Country 140211 0
Australia
Phone 140211 0
+61 435755721
Fax 140211 0
Email 140211 0
[email protected]
Contact person for scientific queries
Name 140212 0
Poppy Watson
Address 140212 0
University of Technology Sydney, 100 Broadway, Sydney, NSW 2007
Country 140212 0
Australia
Phone 140212 0
+61 435755721
Fax 140212 0
Email 140212 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: Data will be made available on open science framework osf,io

Are there extra considerations when requesting access to individual participant data?
No


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.