Pathological GamblingPhase 2NCT01340274
Community Reinforcement Approach and Family Training (CRAFT) for Problem Gambling
A Phase 2 study testing CRAFT treatment and Treatment as Usual in people with Pathological Gambling, run by Colchester East Hants Health Authority at 3 sites in Canada.
Trial summary
Nova Scotia is experiencing a proliferation of gambling opportunities and their related gambling problems. The 2003 Nova Scotia Prevalence Study (2004) found that approximately 50,000 adult Nova Scotians are at some risk for problem gambling and that approximately 93,000 adult Nova Scotians are intimately connected to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- CRAFT treatment and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesCanada
- Study dates
- 3 Jun 2011to 15 Apr 2012
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Concerned Significant Other (CSO) must have a significant relationship with the Individuals Engaged in Problem Gambling (IPG)(e.g. parent, child, sibling, friend, partner).
- CSO must have face-to-face contact with the IPG at least 3 days per week and for at least 1 hour per day with no anticipated relationship change (e.g. separation) over the next 90 days.
- Impaired functioning of the CSO consequential to their significant other being engaged in problem gambling.
- Evidence (from the CSOs) that the IPG meets Canadian Problem Gambling Index (CPGI) criteria for problem gambling.
- The CSO's primary motivation for treatment is to influence their IPG's gambling behaviour.
Who cannot join
- CSO meets CPGI criteria for having problem gambling.
- CSO has a condition, including substance dependency and/or significant psychopathology, which could impede the CSO's ability to understand and participate in treatment.
- The IPG has received treatment for problem gambling in the previous 3 months, is currently willing to receive treatment, or has been court ordered to receive treatment.
- Domestic violence is a significant risk based on the CSOs report and psychometric measure.
- The CSO is currently receiving psychotherapy for issues related to their IPG's gambling.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Addiction Services
Amherst Nova Scotia, Nova Scotia, B0M 1X0
Addiction Services
Pictou, Nova Scotia, B0K 1H0
Addictions Services
Truro, Nova Scotia
About this study
Official title: Evaluating the Benefits of the Community Reinforcement and Family Training(CRAFT) Approach to Concerned Significant Others(CSO) of Individuals Engaged in Problem Gambling (IPGs)
Nova Scotia is experiencing a proliferation of gambling opportunities and their related gambling problems. The 2003 Nova Scotia Prevalence Study (2004) found that approximately 50,000 adult Nova Scotians are at some risk for problem gambling and that approximately 93,000 adult Nova Scotians are intimately connected to at least one person who has a gambling problem. The serious consequences of problem gambling are being felt by the Individuals engaging in Problem Gambling (IPGs), their Concerned Significant Others (CSOs) and their Communities.
Very few IPGs access support services for their gambling problems. Some reports (National Gambling Impact Study Commission 1999) have found that only 3% of IPGs seek treatment. The Nova Scotia Gambling Prevalence Study (2004) states: "Overall, 3.5% (26,000 adults) have been motivated to help someone else with a current gambling problem versus 0.5% (3,700 adults) seeking assistance or information for a personal problem". While the CSOs of IPGs are seven times more likely to access professional addiction treatment the options for these individuals are limited and treatment programs often lack evidence in support of their effectiveness.
Read more
The Community Reinforcement and Family Training (CRAFT) (Meyers \& Wolfe 2004) approach provides significant benefits to the CSOs of persons abusing alcohol and other drugs. They benefits include: improvement in the quality of life of the CSOs; increasing the rate of substance abusers entering treatment; and decreased substance use. CRAFT empowers CSOs by providing tools to positively influence theirs and their significant other's behavior.
The current study investigates the applicability and effectiveness of the CRAFT approach to the CSOs of IPGS.
It is predicted that benefits to the CSOs receiving CRAFT will significantly surpass those receiving treatment as usual. The predicted benefits are: improvement in quality of life for the CSO; engagement of IPGs in treatment; and decreased gambling by the IPGs. With these achieved outcomes, this research will provide opportunity for earlier intervention, improved individual and family functioning and a reduction of the negative impact of problem gambling on the community.
Read the detailed description
It has been estimated that 50,000 adult Nova Scotians are at some risk for problem gambling and approximately 93,000 adult Nova Scotians are intimately connected to at least one person who has a gambling problem (Nova Scotia Prevalence Study 2004). The serious consequences of problem gambling are being felt by Individuals engaged in Problem Gambling (IPGs), their Concerned Significant Others (CSOs) and their Communities.
It is known that despite the negative consequence of problem gambling very few IPGs access services for treating their gambling problems. The Nova Scotia Gambling Prevalence Study (2004) has shown that CSOs are seven times more likely to access services than IPGs "Overall, 3.5% (26,000 adults) have been motivated to help someone else with a current gambling problem versus 0.5% (3,700 adults) seeking assistance or information for a personal problem". Despite such findings the treatment options for the CSOs of IPGs are limited (Crisp, B.R. et al. 2001; Shaw, M.C. et al. 2007).
The Community Reinforcement and Family Training (CRAFT) (Meyers \& Wolfe 2004) model for CSOs of substance abusers has demonstrated significant success with the following outcomes: improvement in the quality of life of CSOs; engagement of the substance abuser in treatment; and decreased substance use. CRAFT empowers CSOs by providing tools to positively influence their own and their significant others behavior through a cognitive behavioral approach.
This current project investigates the applicability and effectiveness of the CRAFT model as a tool for supporting the CSOs of problem gamblers. A comparative analysis will be completed with random assignment of 60 CSOs to either of Group A (CRAFT) or Group B (treatment as usual). Twelve individual treatment sessions will be offered to each of the CSOs. It is predicted the outcomes of from Group A (CRAFT) will significantly surpass those from Group B (treatment as usual). The predicted outcomes are: improvement in quality of life for the CSOs; engagement of the IPGs in treatment; and decreased gambling by the IPGs. All therapists in the CRAFT experimental group have been certified in the CRAFT model. A comparative analysis will be conducted with the CRAFT approach (Group A) and the traditional treatment approach (Group B). Model adherence will be supervised and tested.
- Conditions
- Pathological Gambling
- Being tested
- CRAFT treatment, Treatment as Usual
- Keywords
- Community Reinforcement and Family Training, Concerned Significant Others, Identified Problem Gambler, Therapeutics
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRAFT treatmentBehavioural
Also called Community Reinforcement Approach and Family Training
Clients will receive 12 sessions of CRAFT delivered over a 12 week period. There will be 1 session per week.
Treatment as UsualBehavioural
Also called Cognitive Behavioural Therapy, Motivational Enhancement
Clients will receive Treatment as Usual delivered over 12 session. There will be 1 session per week.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | Clients will receive 12 sessions of "Treatment as usual ", delivered 1 session per week for 12 consecutive weeks. Receives: Behavioral: Treatment as Usual |
| CRAFT Treatment | Experimental | Clients will receive 12 sessions of "CRAFT", delivered 1 session per week for 12 consecutive weeks. Receives: Behavioral: CRAFT treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concerned Significant Other Status (Quality of Life)
Measured through the following Tests:
Beck Depression Inventory (Beck, Steer \& Garbin 1988) State/Trait Anxiety Inventory (Speilberger 1999) State-trait Anger Expression Inventory-II (Speilberger et al. 1988) DSM -IV Screening Questionnaire; Social functioning and Resources Scale (Moos et al 1987) Physical symptoms (Moos et al 1987)
Measured: Baseline: At 0 weeks
Secondary outcomes (2)
Concerned Significant Other Status (Quality of Life)
Measured through the following Tests:
Beck Depression Inventory (Beck, Steer \& Garbin 1988) State/Trait Anxiety Inventory (Speilberger 1999) State-trait Anger Expression Inventory-II (Speilberger et al. 1988) DSM -IV Screening Questionnaire; Social functioning and Resources Scale (Moos et al 1987) Physical symptoms (Moos et al 1987) Significant Other Status (Quality of Life)
Measured: Post treatment: 1 week
Concerned Significant Other Status (Quality of Life)
Measured through the following Tests:
Beck Depression Inventory (Beck, Steer \& Garbin 1988) State/Trait Anxiety Inventory (Speilberger 1999) State-trait Anger Expression Inventory-II (Speilberger et al. 1988) DSM -IV Screening Questionnaire; Social functioning and Resources Scale (Moos et al 1987) Physical symptoms (Moos et al 1987)
Measured: Follow up: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study start3 Jun 2011 (estimated)
- Primary completion15 Apr 2012
- Study completion15 Apr 2012
Why it stopped: Could not get participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colchester East Hants Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Pictou County Health Authority, University of Calgary, Dalhousie University
- Responsible party
- Sponsor
- Investigators
- Greg Purvis, MSc, Principal investigator, Pictou County Health AuthorityDavid Hodgins, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340274
- Sponsor's protocol ID
- 001
- Status last verified
- Apr 2011
- First submitted
- 4 Feb 2011
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Benefits of the Community Reinforcement and Family Training(CRAFT) Approach to Concerned Significant Others(CSO) of Individuals Engaged in Problem Gambling (IPGs)
- ClinicalTrials.gov ID
- NCT01340274
- Acronym / sponsor ID
- 001
- Conditions
- Pathological Gambling
- Keywords
- Community Reinforcement and Family Training, Concerned Significant Others, Identified Problem Gambler, Therapeutics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not get participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Colchester East Hants Health AuthorityUniversity, hospital or other
- Collaborators
- Pictou County Health Authority, University of Calgary, Dalhousie University
- Study start
- 3 Jun 2011 (estimated)
- Primary completion
- 15 Apr 2012 (actual)
- Study completion
- 15 Apr 2012 (actual)
- First posted
- 22 Apr 2011 (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.
Nova Scotia is experiencing a proliferation of gambling opportunities and their related gambling problems. The 2003 Nova Scotia Prevalence Study (2004) found that approximately 50,000 adult Nova Scotians are at some risk for problem gambling and that approximately 93,000 adult Nova Scotians are intimately connected to at least one person who has a gambling problem. The serious consequences of problem gambling are being felt by the Individuals engaging in Problem Gambling (IPGs), their Concerned Significant Others (CSOs) and their Communities.
Very few IPGs access support services for their gambling problems. Some reports (National Gambling Impact Study Commission 1999) have found that only 3% of IPGs seek treatment. The Nova Scotia Gambling Prevalence Study (2004) states: "Overall, 3.5% (26,000 adults) have been motivated to help someone else with a current gambling problem versus 0.5% (3,700 adults) seeking assistance or information for a personal problem". While the CSOs of IPGs are seven times more likely to access professional addiction treatment the options for these individuals are limited and treatment programs often lack evidence in support of their effectiveness.
The Community Reinforcement and Family Training (CRAFT) (Meyers \& Wolfe 2004) approach provides significant benefits to the CSOs of persons abusing alcohol and other drugs. They benefits include: improvement in the quality of life of the CSOs; increasing the rate of substance abusers entering treatment; and decreased substance use. CRAFT empowers CSOs by providing tools to positively influence theirs and their significant other's behavior.
The current study investigates the applicability and effectiveness of the CRAFT approach to the CSOs of IPGS.
It is predicted that benefits to the CSOs receiving CRAFT will significantly surpass those receiving treatment as usual. The predicted benefits are: improvement in quality of life for the CSO; engagement of IPGs in treatment; and decreased gambling by the IPGs. With these achieved outcomes, this research will provide opportunity for earlier intervention, improved individual and family functioning and a reduction of the negative impact of problem gambling on the community.
Detailed description
It has been estimated that 50,000 adult Nova Scotians are at some risk for problem gambling and approximately 93,000 adult Nova Scotians are intimately connected to at least one person who has a gambling problem (Nova Scotia Prevalence Study 2004). The serious consequences of problem gambling are being felt by Individuals engaged in Problem Gambling (IPGs), their Concerned Significant Others (CSOs) and their Communities.
It is known that despite the negative consequence of problem gambling very few IPGs access services for treating their gambling problems. The Nova Scotia Gambling Prevalence Study (2004) has shown that CSOs are seven times more likely to access services than IPGs "Overall, 3.5% (26,000 adults) have been motivated to help someone else with a current gambling problem versus 0.5% (3,700 adults) seeking assistance or information for a personal problem". Despite such findings the treatment options for the CSOs of IPGs are limited (Crisp, B.R. et al. 2001; Shaw, M.C. et al. 2007).
The Community Reinforcement and Family Training (CRAFT) (Meyers \& Wolfe 2004) model for CSOs of substance abusers has demonstrated significant success with the following outcomes: improvement in the quality of life of CSOs; engagement of the substance abuser in treatment; and decreased substance use. CRAFT empowers CSOs by providing tools to positively influence their own and their significant others behavior through a cognitive behavioral approach.
This current project investigates the applicability and effectiveness of the CRAFT model as a tool for supporting the CSOs of problem gamblers. A comparative analysis will be completed with random assignment of 60 CSOs to either of Group A (CRAFT) or Group B (treatment as usual). Twelve individual treatment sessions will be offered to each of the CSOs. It is predicted the outcomes of from Group A (CRAFT) will significantly surpass those from Group B (treatment as usual). The predicted outcomes are: improvement in quality of life for the CSOs; engagement of the IPGs in treatment; and decreased gambling by the IPGs. All therapists in the CRAFT experimental group have been certified in the CRAFT model. A comparative analysis will be conducted with the CRAFT approach (Group A) and the traditional treatment approach (Group B). Model adherence will be supervised and tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualClients will receive 12 sessions of "Treatment as usual ", delivered 1 session per week for 12 consecutive weeks. |
| CRAFT Treatment | Experimental | Behavioral: CRAFT treatmentClients will receive 12 sessions of "CRAFT", delivered 1 session per week for 12 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Concerned Significant Other (CSO) must have a significant relationship with the Individuals Engaged in Problem Gambling (IPG)(e.g. parent, child, sibling, friend, partner).
- CSO must have face-to-face contact with the IPG at least 3 days per week and for at least 1 hour per day with no anticipated relationship change (e.g. separation) over the next 90 days.
- Impaired functioning of the CSO consequential to their significant other being engaged in problem gambling.
- Evidence (from the CSOs) that the IPG meets Canadian Problem Gambling Index (CPGI) criteria for problem gambling.
- The CSO's primary motivation for treatment is to influence their IPG's gambling behaviour.
Key exclusion criteria (5 listed)
- CSO meets CPGI criteria for having problem gambling.
- CSO has a condition, including substance dependency and/or significant psychopathology, which could impede the CSO's ability to understand and participate in treatment.
- The IPG has received treatment for problem gambling in the previous 3 months, is currently willing to receive treatment, or has been court ordered to receive treatment.
- Domestic violence is a significant risk based on the CSOs report and psychometric measure.
- The CSO is currently receiving psychotherapy for issues related to their IPG's gambling.
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 |
|---|---|---|
| CRAFT treatmentAlso: Community Reinforcement Approach and Family TrainingClients will receive 12 sessions of CRAFT delivered over a 12 week period. There will be 1 session per week. | Behavioural | CRAFT Treatment |
| Treatment as UsualAlso: Cognitive Behavioural Therapy, Motivational EnhancementClients will receive Treatment as Usual delivered over 12 session. There will be 1 session per week. | Behavioural | Treatment as Usual |
Primary outcome
Concerned Significant Other Status (Quality of Life)
Time frame: Baseline: At 0 weeks
Measured through the following Tests: Beck Depression Inventory (Beck, Steer \& Garbin 1988) State/Trait Anxiety Inventory (Speilberger 1999) State-trait Anger Expression Inventory-II (Speilberger et al. 1988) DSM -IV Screening Questionnaire; Social functioning and Resources Scale (Moos et al 1987) Physical symptoms (Moos et al 1987)
2 secondary outcomes
Concerned Significant Other Status (Quality of Life)
Time frame: Post treatment: 1 week
Concerned Significant Other Status (Quality of Life)
Time frame: Follow up: 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
Related trials for Pathological Gambling
Not yet recruiting
Theory-based Intervention for Promoting Responsible Gambling Among College Students
Problem Gambling, Pathological Gambling
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.
Greg Purvis, MSc principal investigator
Pictou County Health Authority
David Hodgins, PhD principal investigator
University of Calgary
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRAFT treatment and Treatment as Usual in people with Pathological Gambling, run by Colchester East Hants Health Authority at 3 sites 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Concerned Significant Other Status (Quality of Life) (time frame: Baseline: At 0 weeks). 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 23 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.