Problem GamblingNCT06011070
Brief Online Personalised Feedback Intervention for Gambling Harm
A study testing Gambling Personalised Feedback in people with Problem Gambling, run by King's College London at 1 site in United Kingdom.
Trial summary
Purpose and significance A brief self-directed online personalised feedback intervention was developed for the UK context designed to prevent, reduce, and address gambling harm. The intervention, which also comes in a paper format, comprises of normative feedback and personalised information on the risk of gambling… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Problem Gambling
- What is being tested?
- Gambling Personalised Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,586 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Aug 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Problem gambling severity index score of 3 or more
- Willingness to complete 1 and 3-month follow-up surveys
Who cannot join
- Do not live in the United Kingdom
- Incorrectly answer attention check question on baseline survey
- Do not endorse that they answered all questions truthfully on the baseline survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomised Trial of a Brief Online Personalised Feedback Intervention for the UK Context Designed to Prevent, Reduce, and Address Gambling Harm
Purpose and significance A brief self-directed online personalised feedback intervention was developed for the UK context designed to prevent, reduce, and address gambling harm. The intervention, which also comes in a paper format, comprises of normative feedback and personalised information on the risk of gambling above lower-risk gambling guidelines. The content is based on recent work adapting the Canadian lower-risk gambling guidelines to the UK context. The purpose of this exploratory research is to conduct the first randomised controlled trial of this intervention. Further, given the increased prevalence of online gambling, the project will target this at-risk population.
Rationale This project will generate participant feedback on the intervention important to improve its utility. The project will also produce publishable findings on the intervention's efficacy. This evaluation provides a necessary first step towards the wide-spread implementation of this free-of-charge intervention in the UK.
Read more
Methodology First, using methods developed in our previous research, we will rapidly recruit 926 online gambling participants with moderate or problem gambling from an existing online panel of UK residents. These participants will be randomised to receive the self-directed online intervention or assigned to a no intervention control group. Participants will be followed-up up at one- and three-months to provide detailed feedback on their impressions of the intervention (and what further modifications are needed) and to assess the short-term impact of the intervention on gambling frequency and harm.
Potential implications of the proposed research The intervention can be accessed at any time of the day and allow the delivery of help without requiring face-to-face contact. Online interventions also have the potential to promote reductions in social inequalities through reducing barriers to accessible care. At present, there appears to be no UK online at-risk gambling intervention that is publicly available.
- Conditions
- Problem Gambling
- Being tested
- Gambling Personalised Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gambling Personalised FeedbackBehavioural
The intervention is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in gambling
| Study group | Role | What they receive |
|---|---|---|
| Gambling Personalised Feedback | Experimental | The intervention is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in gambling Receives: Behavioral: Gambling Personalised Feedback |
| Control | No intervention | No intervention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days gambled in the last month
The number of days the participants reports gambling in the past month
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start21 Aug 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem GamblingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,586 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011070
- Sponsor's protocol ID
- HR-22/23-36398
- Status last verified
- Feb 2024
- First submitted
- 21 Aug 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomised Trial of a Brief Online Personalised Feedback Intervention for the UK Context Designed to Prevent, Reduce, and Address Gambling Harm
- ClinicalTrials.gov ID
- NCT06011070
- Acronym / sponsor ID
- HR-22/23-36398
- Conditions
- Problem Gambling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,586 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose and significance A brief self-directed online personalised feedback intervention was developed for the UK context designed to prevent, reduce, and address gambling harm. The intervention, which also comes in a paper format, comprises of normative feedback and personalised information on the risk of gambling above lower-risk gambling guidelines. The content is based on recent work adapting the Canadian lower-risk gambling guidelines to the UK context. The purpose of this exploratory research is to conduct the first randomised controlled trial of this intervention. Further, given the increased prevalence of online gambling, the project will target this at-risk population.
Rationale This project will generate participant feedback on the intervention important to improve its utility. The project will also produce publishable findings on the intervention's efficacy. This evaluation provides a necessary first step towards the wide-spread implementation of this free-of-charge intervention in the UK.
Methodology First, using methods developed in our previous research, we will rapidly recruit 926 online gambling participants with moderate or problem gambling from an existing online panel of UK residents. These participants will be randomised to receive the self-directed online intervention or assigned to a no intervention control group. Participants will be followed-up up at one- and three-months to provide detailed feedback on their impressions of the intervention (and what further modifications are needed) and to assess the short-term impact of the intervention on gambling frequency and harm.
Potential implications of the proposed research The intervention can be accessed at any time of the day and allow the delivery of help without requiring face-to-face contact. Online interventions also have the potential to promote reductions in social inequalities through reducing barriers to accessible care. At present, there appears to be no UK online at-risk gambling intervention that is publicly available.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gambling Personalised Feedback | Experimental | Behavioral: Gambling Personalised FeedbackThe intervention is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in gambling |
| Control | No intervention | –No intervention Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Problem gambling severity index score of 3 or more
- Willingness to complete 1 and 3-month follow-up surveys
Key exclusion criteria (3 listed)
- Do not live in the United Kingdom
- Incorrectly answer attention check question on baseline survey
- Do not endorse that they answered all questions truthfully on the baseline survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gambling Personalised FeedbackThe intervention is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in gambling | Behavioural | Gambling Personalised Feedback |
Primary outcome
number of days gambled in the last month
Time frame: 1 and 3 months
The number of days the participants reports gambling in the past month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gambling Personalised Feedback in people with Problem Gambling, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of days gambled in the last month (time frame: 1 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.