Condition category
Not Applicable
Date applied
30/10/2020
Date assigned
19/11/2020
Last edited
19/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Over 400,000 individuals in the UK identify as problem gamblers, a number that is rapidly expanding given the increasing popularity of online gambling. At the same time, it is rare that those affected seek treatment. Currently, the point at which someone shifts from being a social gambler to a problem gambler is not known. The stigma around gambling means gamblers rarely seek treatment and prefer anonymity, hence online interventions are likely to be well-received. The aim of this study is to test the feasibility and acceptability to gamblers of online interventions using data-driven feedback, SMART (Specific-Measurable-Attainable-Realistic and Time-Bound) goal-setting, and data-driven social norms. . It will also help us to find out whether a large-scale trial is possible and if so, help us to plan it.

Who can participate?
Adults aged 18 or over in the UK who place bets at least once a week

What does the study involve?
Participants will be randomly allocated to one of 4 groups:
1. Goal setting intervention
2. Descriptive norm messages (information about how other people gamble)
3. Injunctive norm messages (information about other people’s attitudes to gambling)
4. Wait-list control group (no additional treatment)
All three groups take part in the study over the internet for 6 weeks, but the content of the programme is different for each group. All participants will be asked to share their previous week's gambling-related data with the researchers after the baseline questionnaire and after 6 weeks, 3 months, and 6 months. Data will include self-reported mood, beliefs about gambling, quality of life, wellbeing, heath use, and loss of productivity.

What are the possible benefits and risks of participating?
The main benefit is that all participants will have the opportunity to receive an intervention over the internet (if they are assigned to the control group they will be invited to receive an intervention once the study has finished) which makes it possible to receive support over geographical distances and at times chosen by the participant. Possible risks are that being in the control group might cause negative impacts on wellbeing as participants could feel they are missing out. However, they will be offered the intervention of their choice at the study end.

Where is the study run from?
Department of Psychology, Bournemouth University (UK)

When is the study starting and how long is it expected to run for?
From June 2020 to March 2022

Who is funding the study?
GambleAware (UK)

Who is the main contact?
Dr Emily Arden-Close
eardenclose@bournemouth.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emily Arden-Close

ORCID ID

http://orcid.org/0000-0002-5954-2598

Contact details

Department of Psychology
Faculty of Science and Technology
Bournemouth University Talbot Campus
Fern Barrow
Poole
BH12 5BB
United Kingdom
+44 (0)1202 965529
eardenclose@bournemouth.ac.uk

Type

Scientific

Additional contact

Dr John McAlaney

ORCID ID

Contact details

Department of Psychology
Faculty of Science and Technology
Bournemouth University Talbot Campus
Fern Barrow
Poole
BH12 5BB
United Kingdom
+44 (0)1202 964930
jmcalaney@bournemouth.ac.uk

Type

Public

Additional contact

Dr Emily Arden-Close

ORCID ID

http://orcid.org/0000-0002-5954-2598

Contact details

Department of Psychology
Faculty of Science and Technology
Bournemouth University Talbot Campus
Fern Barrow
Poole
BH12 5BB
United Kingdom
+44 (0)1202 965529
eardenclose@bournemouth.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

A 4-arm randomised controlled feasibility study of online social norms and goal setting for promoting responsible gambling in low to moderate gamblers

Acronym

Study hypothesis

1. Assess the acceptability and feasibility of key aspects of study design, randomisation and recruitment processes
2. Estimate recruitment and retention rates
3. Assess the suitability of the outcome measures and inform the selection of the primary outcome for a future full-scale RCT
4. Explore participants’ experiences (including barriers and facilitators) of participating in the study, receiving the interventions and completing the outcome measures, via telephone interviews
5. Determine whether a data-driven social norm approach to promoting responsible gambling is acceptable to gamblers, as measured by uptake of and adherence to the intervention and feedback from qualitative interviews
6. Collect data on the variability of outcome measures to inform a sample size calculation for a larger trial and obtain preliminary estimates of effect size
7. Provide preliminary information about levels of gambling at which the intervention is most beneficial
8. Pilot questions relating to primary healthcare use and productivity for a future within-trial economic evaluation

Ethics approval

Approved 11/09/2020, Faculty of Science and Technology Ethics Committee, Bournemouth University (Talbot Campus, Fern Barrow, Poole, Dorset, BH12 5BB; +44 (0)1202 961073; researchgovernance@bournemouth.ac.uk), ref: 33247

Study design

Online interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Low to moderate gambling

Intervention

Randomisation will be undertaken via REDCap’s randomisation module with randomisation sequences generated by and uploaded from the Robust Randomisation app by an independent data manager. Participants will be allocated to one of the 4 trial arms using restricted randomisation, with random permuted blocks, in an allocation ratio of 1:1:1:1 with stratification by gender (male/female/prefer not to say or other). Participants will be randomly assigned to one of the following four arms (3 intervention, 1 wait-list control) and all interventions will be delivered for a period of 6 weeks:
1. Goal setting. Participants will be provided visual data about their gambling activity and given the opportunity to set one SMART goal (money-related) per week around their gambling activity. Each week participants will be given feedback based on whether or not their goal was met and invited to set a further goal, which could be the same as the previous goal or different.
2. Descriptive norm. Participants will be sent messages that challenge any misperceptions they have around how much similar others gamble. This information will be presented both textually and graphically, with each message focussing on a different dimension of gambling behaviour
3. Injunctive norm. Participants will be sent messages that challenge any misperceptions they have around how much others believe it is appropriate to gamble. This information will be presented both textually and graphically, with each message focussing on a different dimension of gambling behaviour
4. Wait-list control. Participants in this arm will not receive any intervention during the study. They will be given the option to receive visual feedback on their data following debriefing, combined with either goal setting or social normative feedback.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Feasibility of a future full-scale randomised controlled trial (RCT) and to inform the selection of a primary outcome for a future full-scale RCT

Secondary outcome measures

1. Proportion of participants completing the intervention, completing the required number of sessions, number of early drop-outs from the intervention, reasons for dropouts, overall and by group, between baseline and 6 months
2. Participants' willingness to share their gambling data with researchers assessed by noting whether the participants share their gambling data with the researchers on request at baseline, 6 weeks, 3, and 6 months
3. Number of participants completing the screening questionnaire
4. Numbers of participants recruited from each operator
5. Proportion of participants found eligible for the study
6. Proportion of participants that consent to the study out of those found to be eligible
7. Proportion of participants completing the study out of those registered, number of withdrawals from follow-up data collection, reasons for withdrawal between baseline and 6 months
8. Number of losses to follow-up and characteristics of participants lost to follow-up between baseline and 6 months
9. Proportion of participants with follow-up self-reported outcome data at 6 weeks, 3, and 6 months
10. Overall and item completion rates at baseline, 6 weeks, 3, and 6 months
11. Feedback from qualitative interviews on the acceptability of questionnaires at baseline, 6 weeks, 3, and 6 months
12. Self-reported outcomes:
12.1. Problem gambling severity measured using the Problem Gambling Severity Index (PGSI) at pre-baseline to assess eligibility, baseline, 6 weeks, 3, and 6 months
12.2. Time and number of days spent gambling over the past week at baseline, 6 weeks, 3, and 6 months
12.3. Amount of money spent gambling over the past week as assessed by data from operator websites that participants share with the researchers at baseline, 6 weeks, 3, and 6 months
12.4. Gambling-related cognitions assessed using The Gambling Related Cognitions Scale (GRCS) at baseline, 6 weeks, 3, and 6 months
12.5. Depressive symptoms assessed using the Patient Health Questionnaire (PHQ-8) at baseline, 6 weeks, 3, and 6 months
12.6. Anxiety symptoms assessed using The Generalized Anxiety Disorder 7-item scale (GAD-7) at baseline, 6 weeks, 3, and 6 months
12.7. Quality of life measured using the EUROHIS-QOL at baseline, 3, and 6 months
12.8. Contacts made with GP/nurse in the past 3 months will be self-reported at baseline, 3, and 6 months
12.9. Work productivity assessed using a questionnaire about work productivity at baseline, 3, 6 months
12.9. Capability wellbeing using the ICEpop CAPability measure for Adults (ICECAP-A) at baseline, 3, and 6 months
12.10. Health economic evaluation using the EuroQol 5-Dimension-5 Level (EQ-5D-5L) questionnaire at baseline, 3, and 6 months
12.11. Descriptive and injunctive norms, including perceived descriptive norm of gambling behaviours (such as frequency, amount) and perceived norms of injunctive gambling attitudes (such as desire to gain greater control) reported at baseline, 6 weeks, 3, and 6 months
12.12. Narcissism measured using the Narcissistic Admiration and Rivalry questionnaire (NARQ) at baseline

Overall trial start date

01/06/2020

Overall trial end date

28/02/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥18 years
2. Resident in the UK
3. Gamble online a minimum of once a week or place more than 5 bets per week
4. Have access to the internet
5. Sufficient English language ability to engage with the study
6. Owns a smartphone

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Inability to provide informed consent
2. Score on the Problem Gambling Severity Index (PGSI) is indicative of problem gambling

Recruitment start date

01/12/2020

Recruitment end date

31/08/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bournemouth University
Department of Psychology Faculty of Science and Technology Talbot Campus Fern Barrrow
Poole
BH12 5BB
United Kingdom

Sponsor information

Organisation

Bournemouth University

Sponsor details

Research Development & Support
M402 Melbury House
1-3 Oxford Road
Bournemouth
BH8 8ES
United Kingdom
+44 (0)1202 961073
researchethics@bournemouth.ac.uk

Sponsor type

University/education

Website

https://www1.bournemouth.ac.uk/

Funders

Funder type

Charity

Funder name

GambleAware

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results will be disseminated in a peer-reviewed scientific journal, a report for funder, and a conference presentation. The results will inform the design of a definitive randomised controlled trial.

IPD sharing statement:
Anonymised data will be stored on Bournemouth University’s data repository, BORDAR (https://bordar.bournemouth.ac.uk) which is publicly accessible.

Intention to publish date

28/02/2023

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/11/2020: Trial’s existence confirmed by Bournemouth University.