Pathological GamblingPhase 3NCT00203645
Minimal and Brief Treatments for Pathological Gamblers
A Phase 3 study testing Self-help treatment in people with Pathological Gambling, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of the study is to examine whether problem gamblers who receive therapy calls in addition to a self-help manual will be more likely to quit or cut back on their gambling when compared with problem gamblers who receive just the manual. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- Self-help treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2003to Feb 2009
- Phase
- Phase 3
- 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
- Over age 17
- Perception of a gambling problem and a score of 3 or higher (moderate risk) on the Canadian Problem Gambling Index.
- Not involved in treatment at present.
- Willingness to read a short book written in English as a major treatment.
- Willing to have telephone contacts recorded.
- Willing to provide follow-up data on gambling.
- Willing to provide the name of a collateral to help locate them for follow-up interviews.
- Must have gambled at least once in the past month
Who cannot join
- Participants in the preliminary study will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimal and Brief Treatments for Pathological Gamblers: Developing Effective Treatment Systems
The purpose of the study is to examine whether problem gamblers who receive therapy calls in addition to a self-help manual will be more likely to quit or cut back on their gambling when compared with problem gamblers who receive just the manual.
Read the detailed description
With gambling becoming more accessible, the occurrence of problems related to gambling are on the rise. The costs of problem gambling are enormous.There are social and economic costs, the gambler can sometimes lose a significant relationship, job, or commit an illegal activity. Pathological gamblers are also at risk for developing a general medical condition related to stress. There is a high risk of suicide and problem gamblers also have increased rates of mental health disorders. Relatively few people choose to attend formal treatment programs so it's important to provide a range of options to make treatment more accessible. The present study examines the effectiveness of minimal and brief interventions delivered by the telephone.
Comparison(s): The "Workbook Only Control" condition involves receiving the self-help booklet through the mail after a brief telephone assessment. The "Minimal Treatment" condition involves receiving the same workbook but also having a motivational enhancement intervention by telephone. The "Brief Treatment" condition provides the workbook, motivational enhancement, and follow-up support on six occasions spread over 36 weeks. The "Wait List Control" condition involves participants being assigned to a six week waiting list. Participants are assessed and after a six week waiting period they will have a reassessment at which time they will be sent the gambling self-help workbook.
- Conditions
- Pathological Gambling
- Being tested
- Self-help treatment
- Keywords
- Problem gambling, Self-help manual, Motivation enhancement, Telephone support, Treatment, Pathological gambling
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help treatmentBehavioural
Also called Bibliotherapy, motivational interviewing
Workbook "Becoming a Winner",
| Study group | Role | What they receive |
|---|---|---|
| Brief self-directed treatment | Experimental | self-help workbook plus motivational telephone intervention Receives: Behavioral: Self-help treatment |
| Self-directed plus telephone support | Experimental | Self-help workbook, motivational telephone intervention plus telephone booster calls Receives: Behavioral: Self-help treatment |
| Workbook only | Active comparator | Workbook only Receives: Behavioral: Self-help treatment |
| Waitlist | No intervention | Six week waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Gambling
Measured: 3,6,9 12 months
Money lost
Measured: 3,6,9 12 months
Secondary outcomes (3)
Gambling problem severity
Measured: 12 months
Psychiatric symptoms
Measured: 12 months
Self-efficacy
Measured: 3,6,9,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionApr 2006
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- David C Hodgins, PhD., Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203645
- Sponsor's protocol ID
- 110328 - CIHR
- Other IDs
- 1016 - OPGRC
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Hodgins DC, Currie SR, el-Guebaly N. Motivational enhancement and self-help treatments for problem gambling. J Consult Clin Psychol. 2001 Feb;69(1):50-7. doi: 10.1037//0022-006x.69.1.50.
PubMed 11302277Hodgins DC, Currie S, el-Guebaly N, Peden N. Brief motivational treatment for problem gambling: a 24-month follow-up. Psychol Addict Behav. 2004 Sep;18(3):293-6. doi: 10.1037/0893-164X.18.3.293.
PubMed 15482086
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal and Brief Treatments for Pathological Gamblers: Developing Effective Treatment Systems
- ClinicalTrials.gov ID
- NCT00203645
- Acronym / sponsor ID
- 110328 - CIHR
- Conditions
- Pathological Gambling
- Keywords
- Problem gambling, Self-help manual, Motivation enhancement, Telephone support, Treatment, Pathological gambling
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 20 Sep 2005 (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 purpose of the study is to examine whether problem gamblers who receive therapy calls in addition to a self-help manual will be more likely to quit or cut back on their gambling when compared with problem gamblers who receive just the manual.
Detailed description
With gambling becoming more accessible, the occurrence of problems related to gambling are on the rise. The costs of problem gambling are enormous.There are social and economic costs, the gambler can sometimes lose a significant relationship, job, or commit an illegal activity. Pathological gamblers are also at risk for developing a general medical condition related to stress. There is a high risk of suicide and problem gamblers also have increased rates of mental health disorders. Relatively few people choose to attend formal treatment programs so it's important to provide a range of options to make treatment more accessible. The present study examines the effectiveness of minimal and brief interventions delivered by the telephone.
Comparison(s): The "Workbook Only Control" condition involves receiving the self-help booklet through the mail after a brief telephone assessment. The "Minimal Treatment" condition involves receiving the same workbook but also having a motivational enhancement intervention by telephone. The "Brief Treatment" condition provides the workbook, motivational enhancement, and follow-up support on six occasions spread over 36 weeks. The "Wait List Control" condition involves participants being assigned to a six week waiting list. Participants are assessed and after a six week waiting period they will have a reassessment at which time they will be sent the gambling self-help workbook.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brief self-directed treatment | Experimental | Behavioral: Self-help treatmentself-help workbook plus motivational telephone intervention |
| Self-directed plus telephone support | Experimental | Behavioral: Self-help treatmentSelf-help workbook, motivational telephone intervention plus telephone booster calls |
| Workbook only | Active comparator | Behavioral: Self-help treatmentWorkbook only |
| Waitlist | No intervention | –Six week waitlist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over age 17
- Perception of a gambling problem and a score of 3 or higher (moderate risk) on the Canadian Problem Gambling Index.
- Not involved in treatment at present.
- Willingness to read a short book written in English as a major treatment.
- Willing to have telephone contacts recorded.
Key exclusion criteria (1 listed)
- Participants in the preliminary study will be excluded.
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 |
|---|---|---|
| Self-help treatmentAlso: Bibliotherapy, motivational interviewingWorkbook "Becoming a Winner", | Behavioural | Brief self-directed treatment, Self-directed plus telephone support, Workbook only |
Primary outcome
Days of Gambling
Time frame: 3,6,9 12 months
Money lost
Time frame: 3,6,9 12 months
3 secondary outcomes
Gambling problem severity
Time frame: 12 months
Psychiatric symptoms
Time frame: 12 months
Self-efficacy
Time frame: 3,6,9,12 months
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 16 Feb 2009.
- Background: PubMed 11302277Hodgins DC, Currie SR, el-Guebaly N. Motivational enhancement and self-help treatments for problem gambling. J Consult Clin Psychol. 2001 Feb;69(1):50-7. doi: 10.1037//0022-006x.69.1.50.
- Background: PubMed 15482086Hodgins DC, Currie S, el-Guebaly N, Peden N. Brief motivational treatment for problem gambling: a 24-month follow-up. Psychol Addict Behav. 2004 Sep;18(3):293-6. doi: 10.1037/0893-164X.18.3.293.
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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.
David C Hodgins, PhD. principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Self-help treatment in people with Pathological Gambling, run by University of Calgary 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 8 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: finished, as of the sponsor's last update on 16 Feb 2009. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Days of Gambling (time frame: 3,6,9 12 months). The study lists 2 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 NCT00203645, which also lists 2 linked publications.
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 16 Feb 2009.