Help on demand: a self-help app for gambling problems

ISRCTN	ISRCTN10990330
DOI	https://doi.org/10.1186/ISRCTN10990330

Submission date: 18/10/2024
Registration date: 25/10/2024
Last edited: 22/10/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This research study aims to test the effectiveness of a self-help smartphone app for gambling problems. The content of the app has been studied in other formats (e.g., paper-and-pencil workbook), but never as an app. To test how effective the app is at reducing gambling problems, this study will follow up with participants after 8 weeks of using the app, and also at 3, 6, and 12 months.

Who can participate?
Canadian adults with ongoing gambling problems can participate if they own a smartphone and have access to the internet

What does the study involve?
Eligible participants will complete a baseline assessment, use the app for 8 weeks, and complete a series of follow-up assessments at 8 weeks, 3, 6, and 12 months.

What are the possible benefits and risks of participating?
Participants will be compensated after each follow-up survey is completed. Compensation will be provided via email with an electronic gift card valued at CAD $20. Additionally, this study will help the researchers learn more about how to best help individuals with gambling problems. This is an opportunity for participants to influence the development of new technology-based gambling treatments. Participants may feel uncomfortable at times when asked questions of a personal nature, particularly about gambling behaviour and mental health. They may also experience boredom or fatigue when answering some of the questions.

Where is the study run from?
The University of Calgary

When is the study starting and how long is it expected to run for?
July 2023 to May 2026

Who is funding the study?
The Alberta Gambling Research Institute (AGRI)

Who is the main contact?
Brad Brazeau (brad.brazeau@ucalgary.ca)

Contact information

Mr Brad Brazeau
Public, Scientific

2500 University Drive NW
Calgary, Alberta
T2N1N4
Canada

ORCID ID	0000-0001-6874-5170
Phone	+1 403-210-9500
Email	brad.brazeau@ucalgary.ca

Dr David Hodgins
Principal Investigator

2500 University Dr NW
Calgary, Alberta
T2N1N4
Canada

ORCID ID	0000-0003-2737-5200
Phone	+1 403-210-9500
Email	dhodgins@ucalgary.ca

Study information

Study design	Single-centre two-arm interventional pilot randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Internet/virtual
Study type	Treatment
Participant information sheet	Not available in web format. Please use contact details to request a participant information sheet.
Scientific title	Help on demand: pilot testing of a personalized gambling self-help smartphone app
Study objectives	1. Gamblers in the PA group will demonstrate greater subjective user engagement and objective user engagement compared to those in the SA group. 2. Subjective user engagement will be equally predictive of objective user engagement regardless of treatment group. 3. Objective user engagement will be equally predictive of gambling outcomes (i.e., expenditures, problem severity) regardless of treatment group. 4. Gamblers in the PA group will demonstrate greater reductions in expenditures and problem severity compared to those in the SA group. However, both groups will demonstrate meaningful reductions in those gambling outcomes.
Ethics approval(s)	Approved 29/08/2024, University of Calgary Conjoint Faculties Research Ethics Board (CFREB) (Research Services Office, 2500 University Dr NW, Calgary, Alberta, T2N1N4, Canada; +1 403-220-4283; cfreb@ucalgary.ca), ref: REB24-0639
Health condition(s) or problem(s) studied	Gambling disorder
Intervention	This study will employ two treatment conditions: SA (static app) and PA (personalized app). Both groups will have access to the self-help app for 8 weeks. Participants in the SA group (static app) will be provided access to a default version of the self-help app that does not permit any personalization. App content will be derived from extensive work in our lab developing effective paperback and website-based workbooks for gambling problems. Content is based on cognitive-behavioural and motivational enhancement principles and organized into four modules: self-assessment, goal selection, goal attainment, and goal maintenance. Activities for the SA group are presented in buffet style upon enrolment without any recommended order or suggestion based on assessment data. All activities are repeatable. Daily check-ins will be prompted at the same time for all SA participants. Participants in the PA group (personalized app) are provided access to a customizable version of the same self-help app. Upon opening the app for the first time, PA group members will be prompted to select a treatment goal (abstinence, moderation, maintenance) and given feedback based on their gambling problem severity as to whether their chosen goal is reasonable. They will also be prompted to customize the timing and frequency of daily check-in prompts. Activities will become available one at a time based on recommended order (in contrast to the buffet style of the PA group). Participants in the PA group will also receive a progress report at the end of treatment which compiles their responses within activities into a personal narrative. Participants will be randomized in a 1:1 ratio to each of the two intervention groups (SA; PA), stratified by sex (male, female, other), gambling problem severity (low-moderate, high), and past treatment (yes, no), using the software MINIM (https://www-users.york.ac.uk/~mb55/guide/minim.htm).
Intervention type	Behavioural
Primary outcome measure	1. Objective user engagement is measured using the following usage data from the app: a) total time spent in the app; b) completion status of activities; and c) total number of app logins, after treatment completion at 8 weeks 2. Subjective user engagement is measured using the Mobile App Rating Scale - User Version (uMARS) at treatment completion at 8 weeks
Secondary outcome measures	The following secondary outcome measures are assessed at baseline, 8 weeks, and 3, 6, and 12 months: 1. Past month gambling expenditures measured using retrospective self-report 2. Gambling problem severity measured using the the National Opinion Research Center (NORC) Diagnostic Screen for DSM-5 Gambling Disorder (NODS-GD) 3. General psychological distress measured using the Kessler Psychological Distress Scale (K-10) 4. Anxiety symptoms measured using the Generalized Anxiety Disorder Scale (GAD-7) 5. Depression symptoms measured using the Patient Health Questionnaire (PHQ-9) 6. Alcohol use measured using the Alcohol Use Disorders Identification Test - Consumption questions (AUDIT-C) 7. Cannabis use measured using the Cannabis Use Disorders Identification Test (CUDIT)
Overall study start date	01/07/2023
Completion date	31/05/2026

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	270
Key inclusion criteria	1. 18 years of age or older at the point of enrolment 2. Currently residing in Canada 3. Not currently receiving professional treatment for gambling problems 4. Gambled at least once in the past month 5. Currently has at least a moderate gambling problem (as determined by eligibility screening questionnaire)
Key exclusion criteria	1. Does not own an Apple or Android smartphone (and therefore cannot download the app) 2. Does not have access to the internet
Date of first enrolment	16/09/2024
Date of final enrolment	30/04/2025

Locations

Countries of recruitment

Canada

Study participating centre

University of Calgary

2500 University Dr NW
Calgary, Alberta
T2N1N4
Canada

Sponsor information

University of Calgary
University/education

Research Services Office, 2500 University Dr NW
Calgary, Alberta
T2N1N4
Canada

Phone	+1 403-220-6354
Email	rsoadmin@ucalgary.ca
Website	https://www.research.ucalgary.ca/contact/research-services
"ROR"	https://ror.org/03yjb2x39

Funders

Funder type

Research organisation

Alberta Gambling Research Institute, University of Calgary
Private sector organisation / Universities (academic only)

Alternative name(s): Alberta Gambling Research Institute, University of Alberta, Alberta Gambling Research Institute
Location: Canada

Results and Publications

Intention to publish date	15/05/2026
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The final trial manuscript will be submitted to a peer-reviewed journal for publication. The results will also be presented as a peer-reviewed conference presentation at the Alberta Gambling Research Institution annual conference.
IPD sharing plan	The datasets generated and/or analyzed during the current study will be available upon request from Brad Brazeau (brad.brazeau@ucalgary.ca). All anonymized data will be available upon request after the study has been completed and results have been published, but identifying information will not be released. Data will be available to request for as long as the data is retained, but the timeframe for retention of anonymized data is currently unspecified. The data generated from this study will be the property of the Addictive Behaviours Laboratory. If other researchers wish to request the anonymized data for secondary analyses, they will be asked to provide a one-page summary of the rationale, analytic plan, and significance of the secondary data analyses. This summary will be evaluated by the investigators on the research team. If approved, researchers who wish to conduct secondary analyses will be asked to acknowledge the research team who collected the data as well as the funding source in any resulting publications or presentations.

Editorial Notes

22/10/2024: Study's existence confirmed by the Conjoint Faculties Research Ethics Board (CFREB), University of Calgary.