Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000665730
Ethics application status
Approved
Date submitted
15/04/2022
Date registered
6/05/2022
Date last updated
3/05/2023
Date data sharing statement initially provided
6/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Gaming Habit Hacker: A randomised controlled trial to determine the effect of internet-delivered planning interventions for adult gamers on gaming duration
Scientific title
Gaming Habit Hacker: A randomised controlled trial to determine the effect of internet-delivered planning interventions for adult gamers on gaming duration
Secondary ID [1] 306794 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem gaming 325855 0
Condition category
Condition code
Mental Health 323159 323159 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gaming Habit Hacker is a self-directed internet-delivered brief intervention for gaming reduction. It is informed by the Health Action Process Approach and implementation intentions literature, and delivered in accordance with Self-Determination Theory.

The intervention group will receive Gaming Habit Hacker for 28 days. Gaming Habit Hacker contains a selection of behaviour change techniques aimed at bridging the gap between intention and behaviour. In the order of delivery, specific behaviour change techniques include (i) feedback on assessment, (ii) goal setting, (iii) action planning, (iv) coping planning and (v) feedback on outcomes of behaviour. The Gaming Habit Hacker website is accessed via a website with a log-in.

(i) Feedback on assessment: Participants receive immediate personalised feedback on baseline assessment. Feedback will be presented on a one-page report at the end of the baseline survey on Qualtrics, where Qualtrics will automatically formulate personalised feedback. Personalised normative feedback will be presented on gaming duration. Personalised feedback on scores will be presented on gaming frequency, gaming severity, mental wellbeing, mental distress, relationship quality, sleep difficulty, confidence to resist gaming urges and gaming cravings. The anticipated duration needed to complete the baseline assessment and review the feedback is around 20 minutes.

(ii) Goal setting: In the Gaming Habit Hacker website, participants will construct their goal for gaming reduction. Participants will also set their intended gaming duration and frequency over the next 28 days with the TimeLine FollowForward calendar-based system, which is embedded in the Gaming Habit Hacker website. Using the TimeLine FollowForward aims to improve the clarity and specificity of goals, supports autonomy (Self-Determination Theory), and supports goal intentions. Goal setting is expected to take around 5 minutes to complete.

(iii) Action planning: Participants will develop at least one action plan within the first 7 days in the Gaming Habit Hacker website. Prompts include what, when, and where to implement plans for gaming reduction. Gaming Habit Hacker provides participants with behaviour change strategies for gaming reduction drawn from lived experience research, to guide plan development. Participants can see sample action plans. Participants are also prompted once a week (alongside weekly check-ins) to make additional action plans over the 28-day intervention period. Each action plan is expected to take around 10 minutes to complete.

(iv) Coping planning: Participants will record barriers or obstacles to each action plan and create backup plans in the Gaming Habit Hacker website within the first 7 days. Coping planning is expected to take around 10 minutes to complete. Participants are also prompted once a week (alongside weekly check-ins) to make additional coping plans over the 28-day intervention period. Each coping plan is expected to take around 10 minutes to complete.

(v) Feedback on outcomes of behaviour: Participants will receive at least four sessions of feedback on outcomes on behaviour, in total. Specifically, participants will receive at least one session of feedback on their action and coping plans (the number of feedback sessions depends on how many plans participants make) and three weekly check-ins for feedback on progress. All feedback and communication on action and coping plans will be delivered by a coach in the Gaming Habit Hacker website via in-website goal/plan-specific messaging. Feedback will focus on strengthening the detail of plans and assisting participants in building more effective and comprehensive plans. This session will be delivered within 48 hours of the plan being created in the website, and take around 5 minutes for each plan. A coach will also provide weekly check-ins via email (total of three check-ins across the trial) and provide relevant feedback on progress in the Gaming Habit Hacker website. Feedback will specifically be on the current duration and frequency of gaming against the intended duration and frequency set at the program’s start. Where there is a deviation between goal and behaviour, the coach will prompt the participant to revisit their action and coping plans. The coach will also suggest specific content from lived experience information that might assist with the enhancement of plans. Each weekly check-in will take around 10 minutes, which is around 30 minutes in total for three check-ins. There will be at least two coaches with postgraduate degrees in population health, who received extensive training in the protocol and motivational interviewing (MI). The principal investigator will train coaches in the study protocol. MI training will be provided by the study supervisor, who has a PhD in psychology and clinical expertise in the treatment of addiction. Training will be delivered via a handbook and video conferencing. The anticipated duration of training is 4 hours, and training will be completed at least 3 weeks prior to the first participant enrolment.

The first four items (feedback on assessment, goal setting, action planning, and coping planning) will be completed within the first seven days. Once the minimum requirement of the four items has been completed, the amount of time that participants will spend on the Gaming Habit Hacker website is left to their own discretion. However, participants will be prompted to revisit the website at each check-in to edit, add, and adapt plans over the 28-day intervention period.
Intervention code [1] 323246 0
Treatment: Other
Intervention code [2] 323260 0
Behaviour
Comparator / control treatment
Participants allocated to the comparison group will receive assessment only with weekly check-ins. Participants will receive a one-page report at the end of the baseline assessment. This report will provide a calculation of scores on Qualtrics, against the same assessment items as the intervention group. However, there will be no personalised feedback or explanations of what the scores mean. A coach will also prompt participants to report their duration and frequency of gaming at weekly check-ins (total of three check-ins) via email, rather than through the Gaming Habit Hacker website. These check-ins will be the same intervals as the intervention group but without feedback, to increase retention in the study. The coach will have a postgraduate degree in population health, and have received extensive training in the protocol.
Control group
Active

Outcomes
Primary outcome [1] 330930 0
The primary outcome is gaming duration. Duration is measured with the TimeLine Followback which applies a calendar-based system to assess behaviour. Participants will record the number of hours spent gaming each day. The measure will prompt participants with context (e.g., thinking about where they usually play games) and events over the past 28 days which may have impacted gaming patterns to improve accuracy for recall.
Timepoint [1] 330930 0
Baseline, 4 weeks post-intervention commencement (primary timepoint), and 26 weeks post-intervention commencement.
Secondary outcome [1] 408113 0
For the follow-up evaluation, a secondary outcome is gaming frequency, which is measured by the TimeLine Followback.
Timepoint [1] 408113 0
Baseline, 4 weeks post-intervention commencement, 26 weeks post-intervention commencement.
Secondary outcome [2] 408114 0
For the follow-up evaluation, a secondary outcome is gaming disorder symptoms, which is measured by the Gaming Disorder Scale for Adolescence.
Timepoint [2] 408114 0
Baseline, 4 weeks post-intervention commencement, 26 weeks post-intervention commencement.
Secondary outcome [3] 408115 0
For the follow-up evaluation, planning propensity is measured using an adapted action control questionnaire. This questionnaire is adapted for gaming for this study, from previous intention implementation research
Timepoint [3] 408115 0
Baseline, 4 weeks post-intervention commencement, 26 weeks post-intervention commencement.
Secondary outcome [4] 408116 0
For the follow-up evaluation, a secondary outcome is subjective psychological wellbeing, which is measured by the World Health Organisation Well-Being Index.
Timepoint [4] 408116 0
Baseline, 4 weeks post-intervention commencement, 26 weeks post-intervention commencement.
Secondary outcome [5] 408117 0
For the follow-up evaluation, a secondary outcome is psychological distress, which is measured by the Kessler 6 Distress Scale.
Timepoint [5] 408117 0
Baseline, 4 weeks post-intervention commencement, 26 weeks post-intervention commencement.
Secondary outcome [6] 408118 0
For the follow-up evaluation, a secondary outcome is quality of relationships, which is measured by the Ryff’s Positive Relationships with Others Scale.
Timepoint [6] 408118 0
Baseline, 4 weeks post-intervention commencement, 26 weeks post-intervention commencement.
Secondary outcome [7] 408120 0
For the follow-up evaluation, a secondary outcome is gaming-related self-efficacy to resist gaming urges, which is measured by the Brief Situational Confidence Questionnaire.
Timepoint [7] 408120 0
Baseline, 4 weeks post-intervention commencement, 26 weeks post-intervention commencement.
Secondary outcome [8] 408121 0
For the follow-up evaluation, a secondary outcome is gaming cravings, which is measured by the Penn Alcohol Craving Scale (PACS) adapted for gaming for this study.
Timepoint [8] 408121 0
Baseline, 4 weeks post-intervention commencement, 26 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
Eligibility criteria are as follows: (1) aged 16 or older, (2) living in New Zealand or Australia, (3) ready to take a 28-day challenge to change gaming, (4) willing to complete three online surveys for baseline, post-intervention (4 weeks) and follow-up evaluation (6 months).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they are already receiving professional help for gaming.

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)
Randomisation is with a computer sequence delivered by Qualtrics survey software, and therefore group allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation for simple randomisation will be done automatically by Qualtrics.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 204 participants (136 participants in the intervention group and 68 participants in the control group) are needed to detect an overall group x time effect, assuming a statistical power of 0.9, a variability scale factor of 1, and a type I error rate of 0.05. This calculation was performed in GLIMMPSE using the Hotelling Lawley Trace test and takes into account a 2:1 randomisation and a conservative 50% drop-out rate at the 26-week follow-up. This calculation would allow us to detect a difference in the mean gaming duration between groups that are as small as 10 hours (19 VS 29) at 4 weeks and as small as 9 hours (21 VS 30) at 26 weeks, assuming a standard deviation of 14 hours for all groups and time points. Note that a previous feasibility study with a pre-post design showed that internet-delivered planning interventions for problem gaming had a large effect (a difference of 11.9 hours from baseline to 3-month follow-up) on the primary outcome of gaming hours measured by the TimeLine Followback.

For continuous and categorical variables, descriptive statistics will be presented as means (SD) and frequencies (%) respectively. A linear mixed model will be used to analyse the differences between the intervention and comparison groups regarding the trend of the examined outcomes over 26 weeks. The dependent variable will be the outcomes. The fixed factors will be the group (intervention and comparison) and time (baseline, 4-week post-intervention, and 26-week follow-up evaluation). The interaction effect of group and time will be used to assess the differences over time. Analysis with be performed in SPSS.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
9/05/2022
Actual
9/06/2022
Date of last participant enrolment
Anticipated
30/11/2022
Actual
2/04/2023
Date of last data collection
Anticipated
30/07/2023
Actual
Sample size
Target
204
Accrual to date
Final
215
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24695 0
New Zealand
State/province [1] 24695 0

Funding & Sponsors
Funding source category [1] 311124 0
Charities/Societies/Foundations
Name [1] 311124 0
Ember Korowai Takitini
Country [1] 311124 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
22-30 Park Ave, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 312462 0
None
Name [1] 312462 0
Address [1] 312462 0
Country [1] 312462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310654 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 310654 0
Ethics committee country [1] 310654 0
New Zealand
Date submitted for ethics approval [1] 310654 0
Approval date [1] 310654 0
06/12/2021
Ethics approval number [1] 310654 0
UAHPEC23543

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

Contacts
Principal investigator
Name 118406 0
Miss Jennifer J. Park
Address 118406 0
School of Population Health, University of Auckland, Private Bag 92019, Auckland 1142
Country 118406 0
New Zealand
Phone 118406 0
+64 2108226685
Fax 118406 0
Email 118406 0
[email protected]
Contact person for public queries
Name 118407 0
Jennifer J. Park
Address 118407 0
School of Population Health, University of Auckland, Private Bag 92019, Auckland 1142
Country 118407 0
New Zealand
Phone 118407 0
+64 2108226685
Fax 118407 0
Email 118407 0
[email protected]
Contact person for scientific queries
Name 118408 0
Jennifer J. Park
Address 118408 0
School of Population Health, University of Auckland, Private Bag 92019, Auckland 1142
Country 118408 0
New Zealand
Phone 118408 0
+64 2108226685
Fax 118408 0
Email 118408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.