GamblingNCT00495261
Development and Validation of a Mindfulness Intervention for Problem Gambling: An Exploratory Study
A study testing Mindfulness-enhanced cognitive behavioural therapy (MCBT) and relaxation-enhanced cognitive behavioural therapy (RCBT) in people with Gambling, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
In recent years, mindfulness meditation has been shown to be a promising approach for alleviating emotional distress associated with chronic medical and psychiatric conditions and in reducing relapse following treatment for depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling
- What is being tested?
- Mindfulness-enhanced cognitive behavioural therapy (MCBT) and relaxation-enhanced cognitive behavioural therapy (RCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2007to Nov 2007
- 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
- current diagnosis of pathological gambling
- willingness to practice mindfulness or relaxation
Who cannot join
- substance abuse/dependence (except nicotine)
- concurrent attendance at any treatment in which their gambling is addressed (including Gamblers Anonymous)
Trial locations and contacts
1 site in 1 country.
About this study
In recent years, mindfulness meditation has been shown to be a promising approach for alleviating emotional distress associated with chronic medical and psychiatric conditions and in reducing relapse following treatment for depression. The applicability of mindfulness meditation to problem gambling has not yet been explored. Mindfulness meditation may be particularly suitable for this clinical disorder as it stresses a process-oriented, metacognitive, approach to cognitive pathology in contrast to a content-focused approach, characteristic of traditional approaches to treating cognitive psychopathology. Gambling-related cognitive psychopathology is a well-known characteristic of problem gambling and frequently the target of therapy. Although there is growing evidence that cognitive-behavioral treatments are effective for gambling, outcomes may be improved by teaching gamblers additional ways to cope with cognitive distortions that emphasize metacognitive processes.
Read the detailed description
Hypothesis The mindfulness-enhanced CBT (MCBT) will report significant reductions in the frequency of gambling, gambling urges, gambling cognitions and gambling-related expenditures compared to the relaxation-enhanced CBT (RCBT) at end-of-treatment and at the 3-month follow-up.
Significance
- feasibility of mindfulness interventions for problem gamblers
- tentative data for the effectiveness of the intervention
- an additional clinical tool to treat problem gamblers
- basis of a larger, grant-funded study obtain more definitive data
- Conditions
- Gambling
- Being tested
- Mindfulness-enhanced cognitive behavioural therapy (MCBT), relaxation-enhanced cognitive behavioural therapy (RCBT)
- Keywords
- Gambling, Mindfulness, Cognitive Behavioural Therapy
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-enhanced cognitive behavioural therapy (MCBT)Behavioural
a variation of cognitive behavioural therapy (CBT)
relaxation-enhanced cognitive behavioural therapy (RCBT)Behavioural
a variation of cognitive behavioural therapy (CBT)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Mindfulness-enhanced cognitive behavioural therapy (MCBT) |
| 2 | Active comparator | Not described Receives: Behavioral: relaxation-enhanced cognitive behavioural therapy (RCBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gambling urges
Measured: Baseline, post and 3 month fup
Gambling-related expenditures
Measured: Baseline, post and 3 month fup
Secondary outcomes (2)
treatment adherence
Measured: Baseline, post and 3 month fup
gambling cognitions
Measured: Baseline, post and 3 month fup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Investigators
- Tony Toneatto, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495261
- Sponsor's protocol ID
- 311/2006
- Status last verified
- Jan 2008
- First submitted
- 29 Jun 2007
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Mindfulness Intervention for Problem Gambling: An Exploratory Study
- ClinicalTrials.gov ID
- NCT00495261
- Acronym / sponsor ID
- 311/2006
- Conditions
- Gambling
- Keywords
- Gambling, Mindfulness, Cognitive Behavioural Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 3 Jul 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.
In recent years, mindfulness meditation has been shown to be a promising approach for alleviating emotional distress associated with chronic medical and psychiatric conditions and in reducing relapse following treatment for depression. The applicability of mindfulness meditation to problem gambling has not yet been explored. Mindfulness meditation may be particularly suitable for this clinical disorder as it stresses a process-oriented, metacognitive, approach to cognitive pathology in contrast to a content-focused approach, characteristic of traditional approaches to treating cognitive psychopathology. Gambling-related cognitive psychopathology is a well-known characteristic of problem gambling and frequently the target of therapy. Although there is growing evidence that cognitive-behavioral treatments are effective for gambling, outcomes may be improved by teaching gamblers additional ways to cope with cognitive distortions that emphasize metacognitive processes.
Detailed description
Hypothesis The mindfulness-enhanced CBT (MCBT) will report significant reductions in the frequency of gambling, gambling urges, gambling cognitions and gambling-related expenditures compared to the relaxation-enhanced CBT (RCBT) at end-of-treatment and at the 3-month follow-up.
Significance
- feasibility of mindfulness interventions for problem gamblers
- tentative data for the effectiveness of the intervention
- an additional clinical tool to treat problem gamblers
- basis of a larger, grant-funded study obtain more definitive data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Mindfulness-enhanced cognitive behavioural therapy (MCBT) |
| 2 | Active comparator | Behavioral: relaxation-enhanced cognitive behavioural therapy (RCBT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- current diagnosis of pathological gambling
- willingness to practice mindfulness or relaxation
Key exclusion criteria (2 listed)
- substance abuse/dependence (except nicotine)
- concurrent attendance at any treatment in which their gambling is addressed (including Gamblers Anonymous)
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 |
|---|---|---|
| Mindfulness-enhanced cognitive behavioural therapy (MCBT)a variation of cognitive behavioural therapy (CBT) | Behavioural | 1 |
| relaxation-enhanced cognitive behavioural therapy (RCBT)a variation of cognitive behavioural therapy (CBT) | Behavioural | 2 |
Primary outcome
Gambling urges
Time frame: Baseline, post and 3 month fup
Gambling-related expenditures
Time frame: Baseline, post and 3 month fup
2 secondary outcomes
treatment adherence
Time frame: Baseline, post and 3 month fup
gambling cognitions
Time frame: Baseline, post and 3 month fup
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 Jan 2008.
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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.
Tony Toneatto, 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 Mindfulness-enhanced cognitive behavioural therapy (MCBT) and relaxation-enhanced cognitive behavioural therapy (RCBT) in people with 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 2 inclusion and 2 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 Jan 2008. 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?
Gambling urges (time frame: Baseline, post and 3 month fup). 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?
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 Jan 2008.