Susceptibility to Pathological Gambling
Primary Purpose
Pathological Gambling
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Cognition
Sponsored by
About this trial
This is an interventional prevention trial for Pathological Gambling
Eligibility Criteria
Inclusion Criteria:
- Ability to understand the procedures and provide written consent
- Gambled at least 5 times in the past year
- Between the ages of 18 and 29 at intake
Exclusion Criteria:
- Inability to understand the procedures and provide written consent
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control
Mindfulness
Cognition
Arm Description
Psychoeducation
Mindfulness activity and psychoeducation
Cognitive training and psychoeducation
Outcomes
Primary Outcome Measures
Structured Clinical Interview for Pathological Gambling (SCI-PG)
The SCI-PG is a validated and reliable scale assessing the presence of DSM-IV criteria for pathological gambling. The number of criteria met for PG is added for a total score and those meeting 5 or more criteria have DSM-IV pathological gambling.
Subjects are expected to be followed for the duration of the 3 year study.
Diagnostic criteria for pathological gambling every 3 months for the length of the study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01528982
Brief Title
Susceptibility to Pathological Gambling
Official Title
Susceptibility to Pathological Gambling
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to assess the risk factors for the development of pathological gambling.
Detailed Description
This study will track up to 600 young adults (ages 18 to 29) for a two-year period, collecting variables such as gambling behavior, drug and alcohol use, psychiatry and medical history, family history, impulsivity, quality of life, self-esteem, and cognition. For some individuals who meet criteria as being impulsive, they will be randomized to receive an intervention to help reduce their impulsivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
588 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Psychoeducation
Arm Title
Mindfulness
Arm Type
Active Comparator
Arm Description
Mindfulness activity and psychoeducation
Arm Title
Cognition
Arm Type
Active Comparator
Arm Description
Cognitive training and psychoeducation
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Other Intervention Name(s)
Training
Intervention Description
Subjects receive mindfulness training
Intervention Type
Behavioral
Intervention Name(s)
Cognition
Other Intervention Name(s)
Training
Intervention Description
Subject receive cognitive training
Primary Outcome Measure Information:
Title
Structured Clinical Interview for Pathological Gambling (SCI-PG)
Description
The SCI-PG is a validated and reliable scale assessing the presence of DSM-IV criteria for pathological gambling. The number of criteria met for PG is added for a total score and those meeting 5 or more criteria have DSM-IV pathological gambling.
Subjects are expected to be followed for the duration of the 3 year study.
Diagnostic criteria for pathological gambling every 3 months for the length of the study
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ability to understand the procedures and provide written consent
Gambled at least 5 times in the past year
Between the ages of 18 and 29 at intake
Exclusion Criteria:
Inability to understand the procedures and provide written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, JD, MD, MPH
Organizational Affiliation
University of Chicago, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
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Susceptibility to Pathological Gambling
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