Problem GamblingNCT04646421
Responsible Gambling Telephone Intervention to High-risk Gamblers by a State-owned Gambling Operator in Sweden.
An observational study of Problem Gambling and Gambling Disorder, run by Lund University at 1 site in Sweden.
Trial summary
The present overall project evaluates an intervention carried out by the Swedish state-owned gambling operator AB Svenska Spel, in order to help high-risk gamblers reduce or quit their gambling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Problem Gambling, Gambling Disorder
- What is being tested?
- Motivational telephone intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,626 participants
- Where
- 1 siteSweden
- Study dates
- 12 Mar 2021to 30 Nov 2021
- Phase
- Observational
- 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
Study population: Individuals who are gamblers and the AB Svenska Spel sub-section for sports and casino gambling, and who are screened as high-risk gamblers based on an objective measure from the operator or by a voluntary self-test taken by the gambler and indicating a high-risk gambling behavior. Study population retrospective study part: All individuals aimed for the telephone intervention September, 2019-April, 2020, comparing those who were successfully reached by the intervention, to the control individuals (not reached on telephone), Study population prospective study part: Individuals who are reached by the telephone intervention from prospective study start I November, 2020, and who receive a text message intervention 10+ days after the intervention (first business day 10 days after the intervention) and who provide informed consent to study participation.
Who may be able to join
- High-risk gambler as perceived by the high-risk gambling screen by the gambling operator (AB Svenska Spel) or by a voluntary self-test
Who cannot join
- None in the retrospective study. In the prospective study: failure to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Lund University
Lund, 221 00
Anders Håkansson, PhD
About this study
Official title: Responsible Gambling Telephone Intervention to High-risk Gamblers by a State-owned Gambling Operator in Sweden. Effectiveness, User Satisfaction and Acceptability of the Motivational Telephone Intervention of AB Svenska Spel.
The present overall project evaluates an intervention carried out by the Swedish state-owned gambling operator AB Svenska Spel, in order to help high-risk gamblers reduce or quit their gambling. The intervention is a motivational telephone intervention, called by responsible gambling officers trained in motivational interviewing, and who call gamblers who are screened for suspected high-risk gambling practices either through the operator's own records, or because they have voluntarily taken a self-test indicating a hazardous gambling pattern. The present projects evaluates the effectiveness, user satisfaction and acceptability of the intervention, in two parts: 1) A retrospective, register-based follow-up of gamblers reached by the telephone intervention, in comparison to control individuals for whom attempts were made to carry out the same intervention, but who were never successfully reached on telephone. The effectiveness measures include potential changes in gambling level (frequency, level of wagering) post-intervention compared to pre-intervention, as well as occurrence of deposit limits, or voluntary self-exclusion. 2) A prospective web survey study involving individuals reached with the intervention from November, 2020, who - after receiving electronic written information and after providing informed consent - will answer a web survey around 10 days after the intervention, about their attitudes to the telephone intervention, and their self-reported gambling (on the same operator and on other gambling operators), self-limiting interventions and treatment seeking after the intervention. The study will provide important data on the effectiveness of this intervention aiming to reduce high-risk gambling practices, and will be able to study also the risk of gamblers transferring their gambling practices to other operators after a motivational intervention as the present one. Also, as acceptability and user satisfaction of the intervention are crucial for its success over time, these measures are also included in order to improve the understanding or how effective responsible gambling interventions can be implemented by gambling operators with a harm-reducing mission.
Read the detailed description
The project includes two sub-studies:
- Retrospective study part: intervention group (reached with the telephone intervention) and control group (gamblers attempted to be reached but who were not reached by the telephone intervention). Involves objective gambling data post- and pre-intervention, as derived from the AB Svenska Spel databases. Includes the study period September, 2019-April, 2020. Total N of individuals available: 3,626. This study part will also include a sub-analysis, where each individual successfully reached for the motivational telephone call will be compared to a 1:1-matched individual who was not reached (but intended to be reached by the call). Matching is carried out based on the reason for including the individual in the intervention, i.e. either because of a risk screen in a voluntary self-test, or the level of monthly gambling loss. An individual will be matched to a control individual based on the 2,000-SEK interval (approximately 190-Euro inteval) of gambling losses or the inclusion criterion of self-test risk screen.
- Prospective study part: cohort study of individuals reached with the intervention prospectively from November, 2020, and who provide informed consent. Web survey study which collects data on user satisfaction, acceptability, and self-reported changes in gambling (on the same gambling operator and other gambling operators) post-intervention compared to self-reported gambling prior to the intervention. Data collected after sending the survey on the first business day 10 days after the intervention. Target N 200.
The aims of the study are the following:
- Retrospective study part: to study 1a) effects of the telephone intervention, with respect to individuals' level of gambling (frequency and total amount), uptake of responsible gambling tools, and enrolment into self-exclusion, during four weeks after the intervention, in comparison to a period of eight weeks prior to the intervention; 1b) whether the objective effects above differed during the period of COVID-19 pandemic in Sweden (week by week throughout March and April, 2020, compared to previous weeks during the study)
- Prospective study part: to study 2a) participants' subjective attitudes to and experience of the telephone intervention 2b) subjective effects of the intervention on participants' self-reported change in gambling on the same and other operators, and self-reported uptake of self-exclusion
- Conditions
- Problem Gambling, Gambling Disorder
- Being tested
- Motivational telephone intervention
- Keywords
- problem gambling, gambling disorder, behavioral addiction, motivational intervention, COVID-19
- Medical subject headings
- Gambling, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational telephone interventionBehavioural
Motivational telephone intervention to high-risk gamblers, aiming to stimulate them to reduce gambling, quit gambling, or to seek peer support or treatment.
| Study group | Role | What they receive |
|---|---|---|
| Motivational intervention - clients reached | Gamblers successfully reached with the motivational telephone intervention. Receives: Behavioral: Motivational telephone intervention | |
| Control group: clients not reached for the motivational intervention | Clients aimed to be reached for the same intervention, but who were not reached and therefore were not exposed to the intervention. | |
| Prospective intervention group | Clients subject to the prospective study part (target N 200), who are successfully reached by the intervention from November, 2020, and who provide informed consent to the web survey study. Studied as a cohort without control group, but with the pre-intervention situation as their own control condition. Receives: Behavioral: Motivational telephone intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gambling frequency.
Change in wagering (any, and frequency) for each of the specific gambling types, during four weeks after the intervention, compared to the eight weeks prior to the intervention.
Measured: 4 weeks
Change in money wagered
Change in wagering (amounts) for each of the specific gambling types, during four weeks after the intervention, compared to the eight weeks prior to the intervention.
Measured: 4 weeks
Change in money lost
Change in losses for each of the specific gambling types, during four weeks after the intervention, compared to the eight weeks prior to the intervention.
Measured: 4 weeks
Occurrence of any self-limiting intervention post-intervention
Occurrence of deposit limits and voluntary self-exclusions post-intervention,during four weeks after the intervention, compared to the eight weeks prior to the intervention.
Measured: 4 weeks
Change in wagering frequency in both the own operator and other operators
Reduced wagering frequency for each of the specific gambling types, during the approximate 10-day period after the intervention, in gamblers reached with the intervention in the prospective study part (self-reported in survey sent on first business day 10 days after the intervention)
Measured: 10 days
Change in wagering amounts in both the own operator and other operators
Reduced wagering (amounts) and losses for each of the specific gambling types, during the approximate 10-day period after the intervention, in gamblers reached with the intervention in the prospective study part (self-report in survey sent on first business day 10 days after the intervention)
Measured: 10 days
Change in gambling losses in both the own operator and other operators, in prospective study part
Gambling losses (amounts) for each of the specific gambling types, during the approximate 10-day period after the intervention, in gamblers reached with the intervention in the prospective study part (survey sent on first business day 10 days after the intervention)
Measured: 10 days
Occurrence of any self-limiting intervention after the intervention in prospective study part
Occurrence of self-reported voluntary self-exclusions and help-seeking during the approximate 10-day period after the intervention in the prospective study part (self-reported in survey sent on first business day 10 days after the intervention)
Measured: 10 days
Secondary outcomes (3)
Gambler's immediate perception of the call
Gambler's self-reported satisfaction (overall) with the call, as responded by telephone to a direct question from the caller, in the retrospective study part
Measured: 0 days
Gambler's perception of the intervention
Gambler's attitudes to positive and negative effects of the call (feelings of care from the operator and feelings or being annoyed by the call), in the prospective study part (survey sent on first business day 10 days after the intervention)
Measured: 10 days
Gambler's perception of the intervention's effects on gambling
Gambler's attitudes to the call with respect to subjective effects on gambling (increasing/decreasing) and help-seeking, in the prospective study part.(survey sent on first business day 10 days after the intervention)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start12 Mar 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
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.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 3,626 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- AB Svenska Spel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646421
- Sponsor's protocol ID
- omsorgssamtal
- Status last verified
- May 2021
- First submitted
- 6 Nov 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsible Gambling Telephone Intervention to High-risk Gamblers by a State-owned Gambling Operator in Sweden. Effectiveness, User Satisfaction and Acceptability of the Motivational Telephone Intervention of AB Svenska Spel.
- ClinicalTrials.gov ID
- NCT04646421
- Acronym / sponsor ID
- omsorgssamtal
- Conditions
- Problem Gambling, Gambling Disorder
- Keywords
- problem gambling, gambling disorder, behavioral addiction, motivational intervention, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,626 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- AB Svenska Spel
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 30 Nov 2020 (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.
The present overall project evaluates an intervention carried out by the Swedish state-owned gambling operator AB Svenska Spel, in order to help high-risk gamblers reduce or quit their gambling. The intervention is a motivational telephone intervention, called by responsible gambling officers trained in motivational interviewing, and who call gamblers who are screened for suspected high-risk gambling practices either through the operator's own records, or because they have voluntarily taken a self-test indicating a hazardous gambling pattern. The present projects evaluates the effectiveness, user satisfaction and acceptability of the intervention, in two parts: 1) A retrospective, register-based follow-up of gamblers reached by the telephone intervention, in comparison to control individuals for whom attempts were made to carry out the same intervention, but who were never successfully reached on telephone. The effectiveness measures include potential changes in gambling level (frequency, level of wagering) post-intervention compared to pre-intervention, as well as occurrence of deposit limits, or voluntary self-exclusion. 2) A prospective web survey study involving individuals reached with the intervention from November, 2020, who - after receiving electronic written information and after providing informed consent - will answer a web survey around 10 days after the intervention, about their attitudes to the telephone intervention, and their self-reported gambling (on the same operator and on other gambling operators), self-limiting interventions and treatment seeking after the intervention. The study will provide important data on the effectiveness of this intervention aiming to reduce high-risk gambling practices, and will be able to study also the risk of gamblers transferring their gambling practices to other operators after a motivational intervention as the present one. Also, as acceptability and user satisfaction of the intervention are crucial for its success over time, these measures are also included in order to improve the understanding or how effective responsible gambling interventions can be implemented by gambling operators with a harm-reducing mission.
Detailed description
The project includes two sub-studies:
- Retrospective study part: intervention group (reached with the telephone intervention) and control group (gamblers attempted to be reached but who were not reached by the telephone intervention). Involves objective gambling data post- and pre-intervention, as derived from the AB Svenska Spel databases. Includes the study period September, 2019-April, 2020. Total N of individuals available: 3,626. This study part will also include a sub-analysis, where each individual successfully reached for the motivational telephone call will be compared to a 1:1-matched individual who was not reached (but intended to be reached by the call). Matching is carried out based on the reason for including the individual in the intervention, i.e. either because of a risk screen in a voluntary self-test, or the level of monthly gambling loss. An individual will be matched to a control individual based on the 2,000-SEK interval (approximately 190-Euro inteval) of gambling losses or the inclusion criterion of self-test risk screen.
- Prospective study part: cohort study of individuals reached with the intervention prospectively from November, 2020, and who provide informed consent. Web survey study which collects data on user satisfaction, acceptability, and self-reported changes in gambling (on the same gambling operator and other gambling operators) post-intervention compared to self-reported gambling prior to the intervention. Data collected after sending the survey on the first business day 10 days after the intervention. Target N 200.
The aims of the study are the following:
- Retrospective study part: to study 1a) effects of the telephone intervention, with respect to individuals' level of gambling (frequency and total amount), uptake of responsible gambling tools, and enrolment into self-exclusion, during four weeks after the intervention, in comparison to a period of eight weeks prior to the intervention; 1b) whether the objective effects above differed during the period of COVID-19 pandemic in Sweden (week by week throughout March and April, 2020, compared to previous weeks during the study)
- Prospective study part: to study 2a) participants' subjective attitudes to and experience of the telephone intervention 2b) subjective effects of the intervention on participants' self-reported change in gambling on the same and other operators, and self-reported uptake of self-exclusion
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational intervention - clients reached | – | Behavioral: Motivational telephone interventionGamblers successfully reached with the motivational telephone intervention. |
| Control group: clients not reached for the motivational intervention | – | –Clients aimed to be reached for the same intervention, but who were not reached and therefore were not exposed to the intervention. |
| Prospective intervention group | – | Behavioral: Motivational telephone interventionClients subject to the prospective study part (target N 200), who are successfully reached by the intervention from November, 2020, and who provide informed consent to the web survey study. Studied as a cohort without control group, but with the pre-intervention situation as their own control condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are gamblers and the AB Svenska Spel sub-section for sports and casino gambling, and who are screened as high-risk gamblers based on an objective measure from the operator or by a voluntary self-test taken by the gambler and indicating a high-risk gambling behavior. Study population retrospective study part: All individuals aimed for the telephone intervention September, 2019-April, 2020, comparing those who were successfully reached by the intervention, to the control individuals (not reached on telephone), Study population prospective study part: Individuals who are reached by the telephone intervention from prospective study start I November, 2020, and who receive a text message intervention 10+ days after the intervention (first business day 10 days after the intervention) and who provide informed consent to study participation.
Key inclusion criteria (1 listed)
- High-risk gambler as perceived by the high-risk gambling screen by the gambling operator (AB Svenska Spel) or by a voluntary self-test
Key exclusion criteria (1 listed)
- None in the retrospective study. In the prospective study: failure to provide informed consent.
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 |
|---|---|---|
| Motivational telephone interventionMotivational telephone intervention to high-risk gamblers, aiming to stimulate them to reduce gambling, quit gambling, or to seek peer support or treatment. | Behavioural | Motivational intervention - clients reached, Prospective intervention group |
Primary outcome
Change in gambling frequency.
Time frame: 4 weeks
Change in wagering (any, and frequency) for each of the specific gambling types, during four weeks after the intervention, compared to the eight weeks prior to the intervention.
Change in money wagered
Time frame: 4 weeks
Change in wagering (amounts) for each of the specific gambling types, during four weeks after the intervention, compared to the eight weeks prior to the intervention.
Change in money lost
Time frame: 4 weeks
Change in losses for each of the specific gambling types, during four weeks after the intervention, compared to the eight weeks prior to the intervention.
Occurrence of any self-limiting intervention post-intervention
Time frame: 4 weeks
Occurrence of deposit limits and voluntary self-exclusions post-intervention,during four weeks after the intervention, compared to the eight weeks prior to the intervention.
Change in wagering frequency in both the own operator and other operators
Time frame: 10 days
Reduced wagering frequency for each of the specific gambling types, during the approximate 10-day period after the intervention, in gamblers reached with the intervention in the prospective study part (self-reported in survey sent on first business day 10 days after the intervention)
Change in wagering amounts in both the own operator and other operators
Time frame: 10 days
Reduced wagering (amounts) and losses for each of the specific gambling types, during the approximate 10-day period after the intervention, in gamblers reached with the intervention in the prospective study part (self-report in survey sent on first business day 10 days after the intervention)
Change in gambling losses in both the own operator and other operators, in prospective study part
Time frame: 10 days
Gambling losses (amounts) for each of the specific gambling types, during the approximate 10-day period after the intervention, in gamblers reached with the intervention in the prospective study part (survey sent on first business day 10 days after the intervention)
Occurrence of any self-limiting intervention after the intervention in prospective study part
Time frame: 10 days
Occurrence of self-reported voluntary self-exclusions and help-seeking during the approximate 10-day period after the intervention in the prospective study part (self-reported in survey sent on first business day 10 days after the intervention)
3 secondary outcomes
Gambler's immediate perception of the call
Time frame: 0 days
Gambler's perception of the intervention
Time frame: 10 days
Gambler's perception of the intervention's effects on gambling
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Problem Gambling and Gambling Disorder, run by Lund University at 1 site in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anders Håkansson, PhD (+46 46 175596, anders_c.hakansson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gambling frequency. (time frame: 4 weeks). The study lists 8 primary outcomes in all. 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 2 Jun 2021.