Problem GamblingNCT00578357
A Personalized Feedback Intervention for Problem Gamblers
A study testing personalized feedback intervention in people with Problem Gambling, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The main aim of this randomized controlled trial is to evaluate the sustained efficacy of a personalized feedback intervention for problem gamblers. Adult problem gamblers who express an interest in self-help materials for gamblers will be recruited from respondents to a random digit telephone survey, which also… 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?
- personalized feedback intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2007to Jul 2011
- 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
- at least 18 years old
- encompassing the full range of potential problems from moderate problem gambling to gambling dependence as defined by the Canadian Problem Gambling Index (CPGI score of 3 or more)
- spent at least $100.00 in the past year on gambling
- will indicate an interest in self-help materials for problem gamblers.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of this randomized controlled trial is to evaluate the sustained efficacy of a personalized feedback intervention for problem gamblers. Adult problem gamblers who express an interest in self-help materials for gamblers will be recruited from respondents to a random digit telephone survey, which also collects the baseline data. Subjects will be randomly assigned to receive personalized feedback about their gambling, or to a waiting list control group.
Three-month, six-month, and 12-month follow-up surveys will be conducted by mail to assess gambling over the intervening periods. Collaterals will be requested as part of the 12-month follow-up and interviewed by telephone. Gambling at three- six- and 12-months will be compared between the groups. Change in perception of gambling norms and sex will be tested as mediational and moderating variables.
Read the detailed description
Most problem gamblers don't access treatment, often because of stigma, embarrassment or a desire to handle their problems on their own. However, research has demonstrated the effectiveness of self-help interventions for gambling problems, and this area deserves more attention because it addresses a cost-effective means of helping problem gamblers without requiring them to come to treatment. One promising self-help intervention for problem gamblers is personalized feedback. Such interventions have shown consistently positive results with other addictive behaviours, and our pilot test of personalized feedback materials for gamblers showed positive results. This randomized controlled study will evaluate the sustained efficacy of a personalized feedback intervention for problem gamblers in the general population of Ontario. It will also allow testing of the hypothesis that change in perception of gambling norms is a mediator in this process.
Hypothesis 1: Problem gamblers who receive the personalized feedback intervention will reduce their gambling more than problem gamblers who do not receive any intervention (waiting list control condition) by a six-month follow-up.Hypothesis 2: The effect of the intervention will be sustained through the 12-month follow-up.Hypothesis 3 (mediator hypothesis): Respondents in the intervention condition who report greater reductions in their estimates about how much others gamble between baseline and three-month follow-up will demonstrate more improvement in gambling outcomes at six-month follow-up, compared to respondents in the intervention condition who report smaller reductions in their perceived gambling norms.
The design of this study is a randomized (modified) waiting list controlled study. Subjects will be recruited via a random digit dialing telephone screener of the Ontario population. Respondents who are identified by the screener as problem gamblers and who indicate an interest in receiving, at some time in the future, a free computerized summary comparing their gambling to that of other Canadians, will be asked if they will take part in a study to "help us develop and evaluate self-help materials for gamblers." They will be told that the materials and the three-, six- and 12-month follow-up surveys would be mailed to them. Compensation is provided for the completion of each survey.
Provision of name and address will constitute consent. Subjects will be randomly assigned to condition - those in the intervention condition will be sent their personalized feedback - those in the control condition will be asked to tell us what they think should be included in self-help materials for gamblers. (Control subjects will receive the personalized feedback after the six-month follow-up.)
3-month, 6-month, and 12-month follow-up questionnaires will be sent to all subjects.
On the 12-month follow-up subjects will be asked to provide the name, address and telephone number of a collateral.
- Conditions
- Problem Gambling
- Being tested
- personalized feedback intervention
- Keywords
- problem gambling, personalized feedback, gambling addiction
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized feedback interventionBehavioural
personalized feedback will be sent to participants after they complete and return self-help materials/questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | immediate intervention Receives: Behavioral: personalized feedback intervention |
| 2 | No intervention | note: participants in this arm will receive the intervention after the 6-month follow-up (serving as control during the trial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean number of dollars lost per month
Measured: 1 month
mean number of gambled days per month
Measured: 1 month
greatest dollar amount gambled on any day
Measured: 1 day
total CGPI score
Measured: intermittent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Investigators
- John Cunningham, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578357
- Sponsor's protocol ID
- 212/2007
- Status last verified
- Jul 2011
- First submitted
- 18 Dec 2007
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Cunningham JA, Hodgins DC, Toneatto T, Murphy M. A randomized controlled trial of a personalized feedback intervention for problem gamblers. PLoS One. 2012;7(2):e31586. doi: 10.1371/journal.pone.0031586. Epub 2012 Feb 14.
PubMed 22348112
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Feedback Intervention for Problem Gamblers
- ClinicalTrials.gov ID
- NCT00578357
- Acronym / sponsor ID
- 212/2007
- Conditions
- Problem Gambling
- Keywords
- problem gambling, personalized feedback, gambling addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Dec 2007 (estimated)
- 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 main aim of this randomized controlled trial is to evaluate the sustained efficacy of a personalized feedback intervention for problem gamblers. Adult problem gamblers who express an interest in self-help materials for gamblers will be recruited from respondents to a random digit telephone survey, which also collects the baseline data. Subjects will be randomly assigned to receive personalized feedback about their gambling, or to a waiting list control group.
Three-month, six-month, and 12-month follow-up surveys will be conducted by mail to assess gambling over the intervening periods. Collaterals will be requested as part of the 12-month follow-up and interviewed by telephone. Gambling at three- six- and 12-months will be compared between the groups. Change in perception of gambling norms and sex will be tested as mediational and moderating variables.
Detailed description
Most problem gamblers don't access treatment, often because of stigma, embarrassment or a desire to handle their problems on their own. However, research has demonstrated the effectiveness of self-help interventions for gambling problems, and this area deserves more attention because it addresses a cost-effective means of helping problem gamblers without requiring them to come to treatment. One promising self-help intervention for problem gamblers is personalized feedback. Such interventions have shown consistently positive results with other addictive behaviours, and our pilot test of personalized feedback materials for gamblers showed positive results. This randomized controlled study will evaluate the sustained efficacy of a personalized feedback intervention for problem gamblers in the general population of Ontario. It will also allow testing of the hypothesis that change in perception of gambling norms is a mediator in this process.
Hypothesis 1: Problem gamblers who receive the personalized feedback intervention will reduce their gambling more than problem gamblers who do not receive any intervention (waiting list control condition) by a six-month follow-up.Hypothesis 2: The effect of the intervention will be sustained through the 12-month follow-up.Hypothesis 3 (mediator hypothesis): Respondents in the intervention condition who report greater reductions in their estimates about how much others gamble between baseline and three-month follow-up will demonstrate more improvement in gambling outcomes at six-month follow-up, compared to respondents in the intervention condition who report smaller reductions in their perceived gambling norms.
The design of this study is a randomized (modified) waiting list controlled study. Subjects will be recruited via a random digit dialing telephone screener of the Ontario population. Respondents who are identified by the screener as problem gamblers and who indicate an interest in receiving, at some time in the future, a free computerized summary comparing their gambling to that of other Canadians, will be asked if they will take part in a study to "help us develop and evaluate self-help materials for gamblers." They will be told that the materials and the three-, six- and 12-month follow-up surveys would be mailed to them. Compensation is provided for the completion of each survey.
Provision of name and address will constitute consent. Subjects will be randomly assigned to condition - those in the intervention condition will be sent their personalized feedback - those in the control condition will be asked to tell us what they think should be included in self-help materials for gamblers. (Control subjects will receive the personalized feedback after the six-month follow-up.)
3-month, 6-month, and 12-month follow-up questionnaires will be sent to all subjects.
On the 12-month follow-up subjects will be asked to provide the name, address and telephone number of a collateral.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: personalized feedback interventionimmediate intervention |
| 2 | No intervention | –note: participants in this arm will receive the intervention after the 6-month follow-up (serving as control during the trial) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years old
- encompassing the full range of potential problems from moderate problem gambling to gambling dependence as defined by the Canadian Problem Gambling Index (CPGI score of 3 or more)
- spent at least $100.00 in the past year on gambling
- will indicate an interest in self-help materials for problem gamblers.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| personalized feedback interventionpersonalized feedback will be sent to participants after they complete and return self-help materials/questionnaires | Behavioural | 1 |
Primary outcome
mean number of dollars lost per month
Time frame: 1 month
mean number of gambled days per month
Time frame: 1 month
greatest dollar amount gambled on any day
Time frame: 1 day
total CGPI score
Time frame: intermittent
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 26 Jul 2011.
- Derived from this study: PubMed 22348112Cunningham JA, Hodgins DC, Toneatto T, Murphy M. A randomized controlled trial of a personalized feedback intervention for problem gamblers. PLoS One. 2012;7(2):e31586. doi: 10.1371/journal.pone.0031586. Epub 2012 Feb 14.
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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.
John Cunningham, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized feedback intervention in people with Problem Gambling, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 4 inclusion and 0 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 26 Jul 2011. 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 Canada. 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?
mean number of dollars lost per month (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00578357, which also lists 1 linked publication.
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 26 Jul 2011.