Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000490774
Ethics application status
Approved
Date submitted
14/03/2022
Date registered
28/03/2022
Date last updated
3/03/2023
Date data sharing statement initially provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
GAMBLINGLESS: IN-THE-MOMENT: A micro-randomised trial of a gambling Just-In-Time Adaptive Intervention
Scientific title
GAMBLINGLESS: IN-THE-MOMENT: A micro-randomised trial of a Just-In-Time Adaptive Intervention for adult gamblers
Secondary ID [1] 302547 0
None
Universal Trial Number (UTN)
U1111-1259-7423
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem gambling 319419 0
Condition category
Condition code
Mental Health 317393 317393 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GAMBLINGLESS: IN-THE-MOMENT is a Just-In-Time Adaptive Intervention (JITAI) delivered via a smartphone app for people who want to gamble less. The aim of this cognitive-behavioural therapeutic intervention is to prevent cravings, low self-efficacy in high-risk situations, and positive outcome expectancies from transitioning into gambling episodes.

GAMBLINGLESS: IN-THE-MOMENT is informed by the reformulated relapse prevention model. This JITAI employs decision rules specifying that participants who are in a state of receptivity (available for treatment) and report a state of cognitive vulnerability characterised by high craving intensity, low self-efficacy, or positive outcome expectancies (tailoring variables) in Ecological Momentary Assessments (EMAs) sent during three semi-random times a day (decision points) are delivered tailored cognitive-behavioural activities targeting these cognitive processes (intervention options). These components are guided primarily by the long-term goal of reducing gambling symptom severity (distal outcome), which is posited to be achieved through the short-term goal of reducing the likelihood of gambling episodes (primary proximal outcome) via reduced craving intensity, enhanced self-efficacy, and lowered positive outcome expectancies (secondary proximal outcomes).

Trial design
A micro-­randomised trial (MRT), a form of sequential factorial design, will be employed to inform the optimisation of this JITAI. In this MRT, each participant will be randomised to a tailored intervention condition or a no intervention control condition at each decision point across a 28-day period. The MRT will be supplemented with: (1) a within-group follow-up evaluation to explore the longer-term outcomes of the intervention in relation to the primary (gambling symptom severity) and secondary (gambling frequency, gambling expenditure, cravings, self-efficacy, and positive outcome expectancies) outcomes from the pre-intervention evaluation to the post-intervention and six-month follow-up evaluations; and (2) an evaluation of the usability and acceptability of the JITAI using items in the post-intervention evaluation, indices of app usage and engagement, and qualitative telephone interviews.

EMA features:
All participants will be prompted to complete time-based EMAs (t-EMAs) via push notifications at random times during three pre-specified periods (morning, afternoon, and evening). These in-app t-EMAs will consist of single items assessing craving intensity, self-efficacy, positive outcome expectancies (tailoring variables), as well as psychological distress, impulsivity, subjective alcohol intoxication, readiness to change, gambling availability (financial), gambling availability (location), and social context. These items are mostly measured on 5-point Likert scales (from 0-4). The t-EMAs will also include a gambling event record, which will assess gambling episodes (and gambling expenditure) since the last t-EMA completed (e-EMA) (see Primary Outcome).

Intervention content:
This app intervention comprises 53 activities in total (1-15 minutes each to complete), spanning three tailored interventions (modules) detailed below. Selected activities were developed for smartphone delivery with a focus on engagement, interactivity, user preferences, participant literacy, inclusiveness, and ease of use, with an aim to encourage autonomy and create an aesthetically pleasing design. Activities were interactive and gamified using multimedia delivery strategies, comprising a combination of video activities, audio activities, personalised feedback, quizzes, open-ended items, and multiple-choice items.

Intervention 1 Curbing Craving - This intervention comprises 10 activities to help participants manage their gambling cravings to prevent them from transitioning into a gambling episode.

Intervention 2 Tackling Triggers - This intervention contains 25 activities evenly spanned across five types of high-risk situations/triggers, including: (1) financial pressures; (2) unpleasant emotions; (3) social pressure to gamble; (4) testing control over gambling; and (5) conflict with others. Activities aim to improve self-efficacy to resist an urge to gamble in these specific types of high-risk situation.

Intervention 3 Exploring Expectancies - This intervention contains 18 activities evenly spanned across three types of positive outcome expectancies, including: (1) excitement; (2) escape; and (3) money. Activities aim to redress that specific type of positive outcome expectancy.

Intervention options:
Responses to t-EMA items assessing craving intensity, self-efficacy, and positive outcome expectancies (tailoring variables) will be used to determine eligibility for the delivery of the tailored intervention according to a set of predetermined decision rules (>0 on each tailoring variable).

Participants who do not exceed the cut-point for any of the relevant t-EMA items will not be eligible for any intervention. These participants will receive a short encouraging message and their interaction with the app will end.

Importantly, participants who exceed the cut-point for intervention delivery at each t-EMA will be micro-randomised to one of two conditions: (1) a no intervention control condition (in which the participant will receive an encouraging message and their interaction with the app will end) or (2) tailored intervention condition. The micro-randomisation procedure will involve a 25% chance of receiving the intervention control condition and a 75% chance of receiving a tailored intervention condition. Participants who are eligible for more than one intervention will be randomly allocated to an intervention (37.5% chance of receiving either intervention when eligible for two interventions; and 25% chance of receiving any of the intervention when eligible for three interventions).

In the tailored intervention condition, if participants are randomised to receive the Curbing Cravings intervention, they will have the option of selecting which of the 10 activities they want to complete. If participants are randomised to receive the Tackling Triggers or Exploring Expectancies interventions, participants first have to select which of the five high-risk situations or three positive outcome expectancies, respectively, they would like to address in that moment, and then select an activity from that specific group.

Following completion of an intervention activity, participants will be required to complete a post-intervention EMA item specific to the activity completed. Their response to this post-intervention EMA item will be subjected to the same eligibility criteria threshold employed for the t-EMAs. Participants who do not reach exceed the cut-point on the post-intervention EMA item will be presented with an encouraging message and their interaction with the app will end until the next t-EMA. Participants who exceed the cut-point on the post-intervention EMA item are returned to the relevant intervention activity group and asked to select another activity, creating an intervention loop that continues until the participant no longer exceeds the cut-point or closes the app.

Importantly, GAMBLINGLESS: IN-THE-MOMENT includes a “provide nothing” option in situations in which the participant is unreceptive, support is not required, or the provision of support may be unsafe, inconvenient or unethical. Specifically, support will not be offered if the push notification prompting EMA completion is ignored or they press the “snooze” function indicating that are currently unable to complete the EMA (i.e., they are not receptive). Individuals will be allowed two hours to complete an EMA to preserve the momentary nature of the intervention while accommodating the potential for possible unavailability (e.g., driving, working) of the participant at the initial notification time.

Notably, the micro-randomised trial will be conducted over a 28-day period. During this time, intervention activities will only be available in response to the push notification (“push” intervention). These notifications will not be delivered during a six-month follow-up period, but the intervention content will be available to participants “on-demand” during this time (tailored “pull” intervention). During this period of time, participants will be able to access the same tailored intervention activities via a participant-initiated t-EMA.
Intervention code [1] 318835 0
Behaviour
Comparator / control treatment
As outlined in the Intervention section, participants who exceed the cut-point for an intervention at each t-EMA according to the decision rules will be micro-randomised to one of two conditions, including: (1) a no intervention control condition or (2) a tailored intervention condition.

The no intervention control condition is the comparator group in the MRT. Depending on the t-EMA item cut-point met, participants in this condition will receive a short encouraging message indicating that their response suggests that they may be experiencing a craving (Curbing Craving intervention), low confidence to resist gambling in a high-risk situation (Tackling Triggers intervention), or expectations that something good will happen if they gamble (Exploring Expectancies intervention); and suggesting that they should consider doing something to reduce the craving (Curbing Craving), avoid or do something to help cope with the situation (Tackling Triggers), or consider trying to reduce their expectations (Explore Expectancies); however, no intervention will be delivered by the app.
Control group
Active

Outcomes
Primary outcome [1] 325426 0
For the MRT, the primary proximal outcome is the probability of a subsequent gambling episode. This outcome is measured using a single item employed in previous gambling EMA research: “Have you gambled since the last time you checked in?”, with a dichotomous response option.
Timepoint [1] 325426 0
For the MRT, the primary proximal outcome is measured at each subsequent t-EMA.
Primary outcome [2] 325427 0
For the within-group follow-up evaluation, the primary outcome is gambling symptom severity, which is measured using the Gambling Symptom Assessment Scale.
Timepoint [2] 325427 0
For the within-group follow-up evaluation, gambling symptom severity is measured at pre-intervention, post-intervention, and 6-month follow-up evaluations.
Secondary outcome [1] 387915 0
For the MRT, a secondary proximal outcome is subsequent craving intensity, which is measured using a single item adapted from the first item of the Gambling Symptom Assessment Scale.
Timepoint [1] 387915 0
For the MRT, craving intensity is measured at each subsequent t-EMA.
Secondary outcome [2] 387916 0
For the MRT, a secondary proximal outcome is subsequent self-efficacy, which is measured using a single item adapted from the Brief Situational Confidence Questionnaire-Gambling.
Timepoint [2] 387916 0
For the MRT, self-efficacy is measured at each subsequent t-EMA.
Secondary outcome [3] 407642 0
For the MRT, a secondary proximal outcome is subsequent positive outcome expectancies, which is measured using a single item adapted from the Gambling Outcome Expectancy Scale.
Timepoint [3] 407642 0
For the MRT, positive outcome expectancies are measured at each subsequent t-EMA.
Secondary outcome [4] 407643 0
For the within-group follow-up evaluation, a secondary outcome is gambling frequency, which is measured using a TimeLine Follow-Back at the pre-intervention evaluation, e-EMA data at the post-intervention evaluation, and single items at the six-month follow-up evaluation.
Timepoint [4] 407643 0
For the within-group follow-up evaluation, gambling frequency is measured at pre-intervention, post-intervention, and 6-month follow-up evaluations.
Secondary outcome [5] 407644 0
For the within-group follow-up evaluation, a secondary outcome is gambling expenditure, which is measured using a TimeLine Follow-Back at the pre-intervention evaluation, e-EMA data at the post-intervention evaluation, and single items at the six-month follow-up evaluation.
Timepoint [5] 407644 0
For the within-group follow-up evaluation, gambling expenditure is measured at pre-intervention, post-intervention, and 6-month follow-up evaluations.
Secondary outcome [6] 407645 0
For the within-group follow-up evaluation, a secondary outcome is craving to gamble, which is measured using the Penn Alcohol Craving Scale (modified for gambling).
Timepoint [6] 407645 0
For the within-group follow-up evaluation, craving to gamble is measured at pre-intervention, post-intervention, and 6-month follow-up evaluations.
Secondary outcome [7] 407646 0
For the within-group follow-up evaluation, a secondary outcome is self-efficacy, which is measured using the Brief Situational Confidence Questionnaire-Gambling.
Timepoint [7] 407646 0
For the within-group follow-up evaluation, self-efficacy is measured at pre-intervention, post-intervention, and 6-month follow-up evaluations.
Secondary outcome [8] 407647 0
For the within-group follow-up evaluation, a secondary outcome is positive outcome expectancies, which is measured using the Excitement, Escape and Money subscales of the Gambling Outcome Expectancies scale.
Timepoint [8] 407647 0
For the within-group follow-up evaluation, positive outcome expectancies are measured at pre-intervention, post-intervention, and 6-month follow-up evaluations.

Eligibility
Key inclusion criteria
Eligibility criteria will include:
(1) current Australian or New Zealand residence;
(2) 18 years of age or older;
(3) installation of the app from an internet-enabled smartphone;
(4) willingness to receive notifications from the app;
(5) fluency in English language; and
(6) seeking support for one’s own gambling
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Consistent with a pragmatic design, this program will be available to any interested gambler, regardless of the level of gambling symptom severity or whether they are seeking other forms of support or treatment.

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)
Treatment condition allocation procedures will be conducted via the app's pre-specified decision rules without the involvement from any members of the research team. As such, the allocation procedure will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study will be a 28-day MRT. This will involve randomisation into a no intervention control condition or a tailored intervention condition at each t-EMA over the 28-day trial. Micro-randomisation will occur automatically via the app, and because intervention delivery is dependent on participants’ responses to the t-EMAs, participants will not be assigned to the same single intervention condition for the duration of the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other
Other design features
Micro-randomised trial (MRT). Each participant will be randomised to a tailored intervention condition or a no intervention control condition at each decision point across a 28-day period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To assess the research questions, we will use the method of generalised estimating equations (GEE), with appropriate link function for the outcome of interest (e.g., identity, logit). Whilst we intend to use an exchangeable working correlational structure for analyses, we will consider alternative correlational structures based on the observed within person correlation pattern over the course of the study (e.g., independent or autoregressive). For all MRT analyses, we will regress the (lagged) outcome of interest (e.g., gambling episode at Time t+1) on to a variable denoting the intervention received (e.g., Intervention vs No intervention) at Time t, as well as covariates (including unbalanced time). To assess the efficacy of the interventions and which type of intervention option is most beneficial, we will examine the effects of any intervention vs no intervention on the probability of subsequent gambling episode, stratified analyses focusing on each intervention separately versus no intervention (on the specific outcome related to each intervention type, i.e., craving intensity, self-efficacy, positive outcome expectancies), and finally a formal test comparing the magnitude of each intervention to the no intervention condition on probability of subsequent gambling episodes. The identification of the conditions under which the interventions are most beneficial and how the effect of the interventions change over the course of the MRT will be examined by specifying interaction terms between the intervention variable and interaction variable of interest (e.g., psychological distress, time). To explore the longer-term outcomes of the intervention (within-group follow-up evaluation), distal outcomes will also be assessed using GEE by regressing the outcome of interest (e.g., gambling symptom severity) on to a variable denoting time (i.e., pre-intervention, post-intervention, six-month follow-up) and covariates. Where appropriate, we will address missingness using multiple imputation with appropriate accounting for the multilevel nature of the data (e.g., see multilevel multiple imputation).

Using within-group data collected at pre-intervention, post-intervention and 6-month follow-up evaluations, we will consider the clinical significance of any effect in the trial, including: (1) effect sizes (standardised beta); (2) clinically significant change, whereby each participant’s status will be defined as recovered, improved, unchanged, or deteriorated, based on the Gambling Symptom Severity Scale; and (3) an gambling behaviour goal achievement scale, in which the concordance between actual and intended gambling behaviour (frequencey, expenditure) is calculated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/04/2022
Actual
30/03/2022
Date of last participant enrolment
Anticipated
18/08/2023
Actual
Date of last data collection
Anticipated
15/03/2024
Actual
Sample size
Target
200
Accrual to date
228
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24578 0
New Zealand
State/province [1] 24578 0

Funding & Sponsors
Funding source category [1] 306984 0
Government body
Name [1] 306984 0
New South Wales Office of Responsible Gambling
Country [1] 306984 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, 3125 Victoria
Country
Australia
Secondary sponsor category [1] 307548 0
None
Name [1] 307548 0
Address [1] 307548 0
Country [1] 307548 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307115 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 307115 0
221 Burwood Highway, Burwood, 3125 Victoria
Ethics committee country [1] 307115 0
Australia
Date submitted for ethics approval [1] 307115 0
28/08/2020
Approval date [1] 307115 0
08/10/2020
Ethics approval number [1] 307115 0
2020-304

Summary
Brief summary
The aim of this cutting-edge micro-randomised trial is to evaluate the effectiveness of a new Just-In-Time Adaptive Intervention delivered via a smartphone app for people who want to gamble less. This app will provide users with in-the-moment support for gambling cravings, high-risk situations, and positive outcome expectancies to prevent gambling episodes. Participants will complete very brief real-time assessments three times per day via the app, which will be used to determine their eligibility for a real-time intervention. Participants who are eligible to receive an intervention at each assessment time point will be micro-randomised to one of two conditions: a tailored intervention condition or a no-intervention control condition. Participants who are assigned to a tailored intervention condition continue completing intervention activities in a loop until they indicate they no longer need support or close the app. Participants will also complete pre-intervention, post-intervention, and 6-month follow-up evaluations to determine change over time. In so doing, this trial will inform the optimisation of this intervention, evaluate the efficacy of the intervention, and explore when and for whom the intervention is effective.
Trial website
www.gamblingless.org.au (This website will made active during the course of the trial).
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106086 0
Prof Nicki Dowling
Address 106086 0
Deakin University,
221 Burwood highway
Burwood, 3125 Victoria
Country 106086 0
Australia
Phone 106086 0
+61 3 92445610
Fax 106086 0
Email 106086 0
nicki.dowling@deakin.edu.au
Contact person for public queries
Name 106087 0
Prof Nicki Dowling
Address 106087 0
Deakin University,
221 Burwood highway
Burwood, 3125 Victoria
Country 106087 0
Australia
Phone 106087 0
+61 3 92445610
Fax 106087 0
Email 106087 0
nicki.dowling@deakin.edu.au
Contact person for scientific queries
Name 106088 0
Prof Nicki Dowling
Address 106088 0
Deakin University,
221 Burwood highway
Burwood, 3125 Victoria
Country 106088 0
Australia
Phone 106088 0
+61 3 92445610
Fax 106088 0
Email 106088 0
nicki.dowling@deakin.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9466Study protocolDowling, N. A., Merkouris, S. S., Youssef, G. J., Lubman, D. I., Bagot, K. L., Hawker, C. O., ... & Rodda, S. N. (2022). A Gambling Just-In-Time Adaptive Intervention (GamblingLess: In-The-Moment): Protocol for a Microrandomized Trial. JMIR Research Protocols, 11(8), e38958. Chicago https://www.researchprotocols.org/2022/8/e38958/   See study protocol publication details above
9467Clinical study report    TBA



Results publications and other study-related documents

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