A Pilot SMART Design for Pathological Gamblers

Study Overview
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Brief Summary
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Pathological gambling is serious problem, with significant psychological, financial, and public health consequences. Nevertheless, controlled trials examining the efficacy of therapeutic interventions for pathological gamblers are sparse, and many pathological gamblers recover on their own, or with only minimal interventions. In this initial study of a SMART design for pathological gamblers, we will offer a brief intervention to all (n = 100), and subsequently randomize individuals based upon their initial treatment response to varying intensities of additional care from none to 8 sessions of individual cognitive behavioral therapy (CBT) plus 14 weeks of Aftercare. Gambling outcomes will be assessed pre-treatment and at about weeks 10, 24, 36 and 52.

Official Title
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A Pilot SMART Design for Pathological Gamblers

Conditions
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Pathological Gambling

Intervention / Treatment
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* Behavioral: Motivational Enhancement Therapy (MET)
* Behavioral: Cognitive-Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years old, DSM-IV criteria for pathological gambling >2 gambling episodes in past 60 days spent >$100 wagering in the past 60 days willingness to accept random assignment after the brief intervention. Exclusion Criteria: Reading level below 5th grade uncontrolled psychiatric conditions (e.g., active suicidal intention, psychosis, bipolar disorder)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Following 2 sessions of MET intervention received by all patients, patients in Condition 1 receive no further intervention. | Behavioral: Motivational Enhancement Therapy (MET)<br>* MET is a client-centered, directive form of therapy designed to enhance clients' intrinsic motivation to change.<br>|
| Experimental: 2<br>Patients in Condition 2 will receive 8 sessions of the CBT (Cognitive Behavioral Therapy) intervention. | Behavioral: Motivational Enhancement Therapy (MET)<br>* MET is a client-centered, directive form of therapy designed to enhance clients' intrinsic motivation to change.<br>|
| Experimental: 3<br>Patients in Condition 3 will receive 8 sessions of CBT plus aftercare treatment. | Behavioral: Motivational Enhancement Therapy (MET)<br>* MET is a client-centered, directive form of therapy designed to enhance clients' intrinsic motivation to change.<br>Behavioral: Cognitive-Behavioral Therapy (CBT)<br>* In CBT, clients learn to modify their thoughts as well as their behaviors by increasing awareness of the relationship between thoughts, emotions, and actions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self and collateral indices of gambling and gambling related problems |  | baseline and each follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pathological gambling, cognitive-behavioral therapy, motivational enhancement therapy