A Pilot SMART Design for Pathological Gamblers (SMART)
Primary Purpose
Pathological Gambling
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Enhancement Therapy (MET)
Cognitive-Behavioral Therapy (CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Pathological Gambling focused on measuring pathological gambling, cognitive-behavioral therapy, motivational enhancement therapy
Eligibility Criteria
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)
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Following 2 sessions of MET intervention received by all patients, patients in Condition 1 receive no further intervention.
Patients in Condition 2 will receive 8 sessions of the CBT (Cognitive Behavioral Therapy) intervention.
Patients in Condition 3 will receive 8 sessions of CBT plus aftercare treatment.
Outcomes
Primary Outcome Measures
self and collateral indices of gambling and gambling related problems
Secondary Outcome Measures
Full Information
NCT ID
NCT00685724
First Posted
May 23, 2008
Last Updated
April 5, 2019
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00685724
Brief Title
A Pilot SMART Design for Pathological Gamblers
Acronym
SMART
Official Title
A Pilot SMART Design for Pathological Gamblers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling
Keywords
pathological gambling, cognitive-behavioral therapy, motivational enhancement therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Following 2 sessions of MET intervention received by all patients, patients in Condition 1 receive no further intervention.
Arm Title
2
Arm Type
Experimental
Arm Description
Patients in Condition 2 will receive 8 sessions of the CBT (Cognitive Behavioral Therapy) intervention.
Arm Title
3
Arm Type
Experimental
Arm Description
Patients in Condition 3 will receive 8 sessions of CBT plus aftercare treatment.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy (MET)
Intervention Description
MET is a client-centered, directive form of therapy designed to enhance clients' intrinsic motivation to change.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy (CBT)
Intervention Description
In CBT, clients learn to modify their thoughts as well as their behaviors by increasing awareness of the relationship between thoughts, emotions, and actions.
Primary Outcome Measure Information:
Title
self and collateral indices of gambling and gambling related problems
Time Frame
baseline and each follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Petry, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
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A Pilot SMART Design for Pathological Gamblers
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