Data-informed behaviours and responsible gambling
| ISRCTN | ISRCTN37874344 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37874344 |
- Submission date
- 30/10/2020
- Registration date
- 19/11/2020
- Last edited
- 16/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Current plain English summary as of 25/02/2022:
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 feedback, SMART (Specific-Measurable-Attainable-Realistic and Time-Bound) goal-setting, and 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 until end of study)
All three groups will take part in the intervention for 6 weeks over the internet via a secure messaging mobile phone application called WIRE, but the content of the programme will be different for each group. Participants in the goal setting group will be asked to share their previous week's gambling-related data with the researchers during the intervention. In all groups, we intend (with participants’ permission) to obtain participant gambling-related data from gambling operators at the end of the study.
Around 10-12 participants from each of the four groups will be invited for an interview after the intervention to find out about their experiences of the interventions and taking part in the study. We will also interview around 6 participants from the wait-list control group at the end of the study. Participants who take part in an interview will receive a £20 voucher.
Outcome measures will include self-reported mood, beliefs about gambling, quality of life, wellbeing, primary care health use, and 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 WIRE app (if they are assigned to the control group they will be invited to receive their choice of one of the three interventions 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, as noted, they will be offered the intervention of their choice at the study end. Participants will be offered vouchers for completing questionnaires during the study (up to a value of £50).
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 February 2023
Who is funding the study?
GambleAware (UK)
Who is the main contact?
Dr Emily Arden-Close
eardenclose@bournemouth.ac.uk
Previous 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 November 2022
Who is funding the study?
GambleAware (UK)
Who is the main contact?
Dr Emily Arden-Close
eardenclose@bournemouth.ac.uk
Contact information
Scientific
Department of Psychology
Faculty of Science and Technology
Bournemouth University Talbot Campus
Fern Barrow
Poole
BH12 5BB
United Kingdom
 ORCID ID |
0000-0002-5954-2598 |
|---|---|
| Phone | +44 (0)1202 965529 |
| eardenclose@bournemouth.ac.uk |
Scientific
Department of Psychology
Faculty of Science and Technology
Bournemouth University Talbot Campus
Fern Barrow
Poole
BH12 5BB
United Kingdom
| Phone | +44 (0)1202 964930 |
|---|---|
| jmcalaney@bournemouth.ac.uk |
Public
Department of Psychology
Faculty of Science and Technology
Bournemouth University Talbot Campus
Fern Barrow
Poole
BH12 5BB
United Kingdom
| ORCID ID |
0000-0002-5954-2598 |
|---|---|
| Phone | +44 (0)1202 965529 |
| eardenclose@bournemouth.ac.uk |
Study information
| Study design | Online interventional randomized controlled feasibility trial with nested qualitative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | Current study hypothesis as of 25/02/2022: 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 qualitative telephone/video conference interviews 5. Determine whether a 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 Previous 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(s) | 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 |
| Health condition(s) or problem(s) studied | Low to moderate gambling |
| Intervention | Current intervention as of 25/02/2022: Randomisation will be performed via Sealed Envelope™, a centralised, independent, computer-based randomisation service. 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 and all interventions will be delivered for a period of 6 weeks: 1. Goal setting. Participants will be given the opportunity to set one SMART goal (money-related) per week around their gambling activity. Each week participants will be asked to share data about their gambling activity with the researchers, 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 textually, 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 textually, 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 their choice of one of the three interventions (goal setting/descriptive norm/injunctive norm) following debriefing. Nested qualitative study Approximately 10-12 qualitative telephone/video conference interviews per arm will be undertaken after the intervention. Participants will be purposively sampled for diversity of demographic characteristics. Interviews will elicit participants’ experiences of the interventions and of taking part in the study. We will interview 6 participants from the wait-list control group at the end of the study. Previous 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 |
| Primary outcome measure | Current primary outcome measure as of 17/01/2023: Our primary outcomes are feasibility and process outcomes related to determining the feasibility and acceptability of study design, recruitment and randomisation, the data collection strategy, methods and interventions. 1. Proportion of participants completing the interventions, number of sessions completed, (based on whether participants have read social norm messages, or in the case of the goal-setting arm, set a goal) number of early drop-outs from the intervention 2. Participants' willingness to share their gambling data with researchers (goal-setting arm only) (proportion who provide their weekly data during the intervention) 3. Number of participants completing the screening questionnaire 4. Proportion of participants found eligible for the study 5. Proportion of participants that consent to the study out of those found to be eligible 6. 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 7. Number of losses to follow-up and characteristics of participants lost to follow-up 8. Proportion of participants with complete self-reported outcome data at 6 weeks, 3 months and 6 months 9. Outcome measure and item completion rates at baseline, 6 weeks, 3, and 6 months 10. Feedback from qualitative interviews on the acceptability of questionnaires at baseline, 6 weeks, 3, and 6 months _____ Previous 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 | Current secondary outcome measures as of 17/01/2023: Self-reported outcomes: 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 2. Time and number of days spent gambling over the past week at baseline, 6 weeks, 3, and 6 months 3. Amount of money spent gambling over the past week as assessed by data from operators (that participants have given permission to be shared with the researchers) at baseline, 6 weeks, 3, and 6 months 4. Gambling-related cognitions assessed using The Gambling Related Cognitions Scale (GRCS) at baseline, 6 weeks, 3, and 6 months 5. Depressive symptoms assessed using the Patient Health Questionnaire (PHQ-8) at baseline, 6 weeks, 3, and 6 months 6. Anxiety symptoms assessed using The Generalized Anxiety Disorder 7-item scale (GAD-7) at baseline, 6 weeks, 3, and 6 months 7. Quality of life measured using the EUROHIS-QOL at baseline, 3, and 6 months 8. Contacts made with GP/nurse in the past 3 months will be self-reported at baseline, 3, and 6 months 9. Productivity assessed using a questionnaire at baseline, 3 and 6 months 10. Capability wellbeing using the ICEpop CAPability measure for Adults (ICECAP-A) at baseline, 3, and 6 months 11. Generic Quality of Life using the EuroQol 5-Dimension-5 Level (EQ-5D-5L) questionnaire at baseline, 3, and 6 months 12. Descriptive and injunctive norms, including perceived descriptive norms 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 13. Narcissism measured using the Narcissistic Admiration and Rivalry questionnaire (NARQ) at baseline _____ Previous secondary outcome measures as of 25/02/2022: 1. Proportion of participants completing the interventions, number of sessions completed, (based on whether participants have read social norm messages, or in the case of the goal-setting arm, set a goal) number of early drop-outs from the intervention 2. Participants' willingness to share their gambling data with researchers (goal-setting arm only) (proportion who provide their weekly data during the intervention) 3. Number of participants completing the screening questionnaire 4. Proportion of participants found eligible for the study 5. Proportion of participants that consent to the study out of those found to be eligible 6. 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 7. Number of losses to follow-up and characteristics of participants lost to follow-up 8. Proportion of participants with complete self-reported outcome data at 6 weeks, 3 months and 6 months 9. Outcome measure and item completion rates at baseline, 6 weeks, 3, and 6 months 10. Feedback from qualitative interviews on the acceptability of questionnaires at baseline, 6 weeks, 3, and 6 months 11. Self-reported outcomes: 11.1. Problem gambling severity measured using the Problem Gambling Severity Index (PGSI) at pre-baseline to assess eligibility, baseline, 6 weeks, 3, and 6 months 11.2. Time and number of days spent gambling over the past week at baseline, 6 weeks, 3, and 6 months 11.3. Amount of money spent gambling over the past week as assessed by data from operators (that participants have given permission to be shared with the researchers) at baseline, 6 weeks, 3, and 6 months 11.4. Gambling-related cognitions assessed using The Gambling Related Cognitions Scale (GRCS) at baseline, 6 weeks, 3, and 6 months 11.5. Depressive symptoms assessed using the Patient Health Questionnaire (PHQ-8) at baseline, 6 weeks, 3, and 6 months 11.6. Anxiety symptoms assessed using The Generalized Anxiety Disorder 7-item scale (GAD-7) at baseline, 6 weeks, 3, and 6 months 11.7. Quality of life measured using the EUROHIS-QOL at baseline, 3, and 6 months 11.8. Contacts made with GP/nurse in the past 3 months will be self-reported at baseline, 3, and 6 months 11.9. Productivity assessed using a questionnaire at baseline, 3 and 6 months 11.10. Capability wellbeing using the ICEpop CAPability measure for Adults (ICECAP-A) at baseline, 3, and 6 months 11.11. Generic Quality of Life using the EuroQol 5-Dimension-5 Level (EQ-5D-5L) questionnaire at baseline, 3, and 6 months 11.12. Descriptive and injunctive norms, including perceived descriptive norms 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 11.13. Narcissism measured using the Narcissistic Admiration and Rivalry questionnaire (NARQ) at baseline _____ Previous 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 study start date | 01/06/2020 |
| Completion date | 16/02/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 140 (35 per arm) |
| Total final enrolment | 168 |
| Key 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 |
| Key exclusion criteria | 1. Inability to provide informed consent 2. Score on the Problem Gambling Severity Index (PGSI) is indicative of problem gambling |
| Date of first enrolment | 01/12/2020 |
| Date of final enrolment | 30/06/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Faculty of Science and Technology
Talbot Campus
Fern Barrrow
Poole
BH12 5BB
United Kingdom
Sponsor information
University/education
Research Development & Support
M402 Melbury House
1-3 Oxford Road
Bournemouth
BH8 8ES
England
United Kingdom
| Phone | +44 (0)1202 961073 |
|---|---|
| researchethics@bournemouth.ac.uk | |
| Website | https://www1.bournemouth.ac.uk/ |
"ROR" |
https://ror.org/05wwcw481 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| 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 plan | Anonymised data will be stored on Bournemouth University’s data repository, BORDAR (https://bordar.bournemouth.ac.uk) which is publicly accessible. Added 06/01/2023: Type of data stored: quantitative and qualitative All participants gave consent to their data being stored in the data repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 14/03/2023 | 15/03/2023 | Yes | No |
Editorial Notes
16/09/2024: The intention to publish date was changed from 30/09/2024 to 30/09/2025.
04/03/2024: The intention to publish date was changed from 28/02/2024 to 30/09/2024.
15/03/2023: Publication reference added.
17/01/2023: The following changes were made to the trial record:
1. The intention to publish date was changed from 28/02/2023 to 28/02/2024.
2. The primary outcome measure was changed.
3. The secondary outcome measures were changed.
06/01/2023: The following changes were made to the trial record:
1. The overall trial end date has been changed from 31/01/2023 to 16/02/2023.
2. Total final enrolment added.
3. IPD sharing statement updated.
16/06/2022: The following changes have been made:
1. The recruitment end date has been changed from 15/06/2022 to 30/06/2022.
2. The overall trial end date has been changed from 15/01/2023 to 31/01/2023.
26/05/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2022 to 15/06/2022.
2. The overall trial end date has been changed from 30/11/2022 to 15/01/2023 and the plain English summary has been updated to reflect this change.
3. The target number of participants has been changed from "200" to "140 (35 per arm)" and the total target enrolment has been changed from 200 to 140.
25/02/2022: The following changes have been made:
1. The study hypothesis has been updated.
2. The study design has been changed from "Online interventional randomized controlled trial" to "Online interventional randomized controlled feasibility trial with nested qualitative study".
3. The intervention has been updated.
4. The secondary outcome measures have been updated.
5. The plain English summary has been updated.
21/02/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/08/2022 to 30/11/2022.
2. The recruitment end date was changed from 28/02/2022 to 31/05/2022.
3. The plain English summary was updated to reflect these changes.
06/08/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/08/2021 to 28/02/2022.
2. The overall trial end date has been changed from 28/02/2022 to 31/08/2022 and the plain English summary has been updated to reflect this change.
11/11/2020: Trial’s existence confirmed by Bournemouth University.
