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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01340274
Other study ID # 001
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date June 3, 2011
Est. completion date April 15, 2012

Study information

Verified date April 2011
Source Colchester East Hants Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 15, 2012
Est. primary completion date April 15, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Concerned Significant Other (CSO) must have a significant relationship with the Individuals Engaged in Problem Gambling (IPG)(e.g. parent, child, sibling, friend, partner).

2. 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.

3. Impaired functioning of the CSO consequential to their significant other being engaged in problem gambling.

4. Evidence (from the CSOs) that the IPG meets Canadian Problem Gambling Index (CPGI) criteria for problem gambling.

5. The CSO's primary motivation for treatment is to influence their IPG's gambling behaviour.

Exclusion Criteria:

1. CSO meets CPGI criteria for having problem gambling.

2. CSO has a condition, including substance dependency and/or significant psychopathology, which could impede the CSO's ability to understand and participate in treatment.

3. 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.

4. Domestic violence is a significant risk based on the CSOs report and psychometric measure.

5. The CSO is currently receiving psychotherapy for issues related to their IPG's gambling.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CRAFT treatment
Clients will receive 12 sessions of CRAFT delivered over a 12 week period. There will be 1 session per week.
Treatment as Usual
Clients will receive Treatment as Usual delivered over 12 session. There will be 1 session per week.

Locations

Country Name City State
Canada Addiction Services Amherst Nova Scotia
Canada Addiction Services Pictou Nova Scotia
Canada Addictions Services Truro Nova Scotia

Sponsors (4)

Lead Sponsor Collaborator
Colchester East Hants Health Authority Dalhousie University, Pictou County Health Authority, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Baseline: At 0 weeks
Secondary 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)
Post treatment: 1 week
Secondary 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)
Follow up: 9 months
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