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Cognitive Behavioral Therapy for Pathological Gambling

Primary Purpose

Pathological Gambling

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Wait-list
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pathological Gambling focused on measuring Gambling

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Outpatient men and women age 18 to 75 Presence of current DSM-IV pathological gambling for at least 6 months duration PG is the most problematic psychiatric disorder (in the patient's and clinician's opinion) and the primary reason for seeking treatment Minimum score of >5 on the South Oaks Gambling Screen which reflects gambling severity consistent with pathological gambling Exclusion Criteria: Current clinically significant suicidality, severe depression (a score of ≥ 19 on the Hamilton Rating Scale for Depression, 17-item version)(30) or any other disorder requiring immediate intervention Presence of any clinical features requiring a higher level of care than outpatient treatment Cognitive impairment that interferes with the capacity to engage in CBT or to provide informed consent DSM-IV substance abuse or dependence within the past 3 months (see Screening Visit) Current Axis I diagnosis of bipolar disorder or psychotic disorder Previous treatment of CBT for PG (duration of at least 6 sessions); because CBT is not widely used for PG, a minimum of 6 treatments will be rare. Current use of psychotropic medications or within 2 months prior to study entry. Current participation in Gambler's Anonymous (GA).

Sites / Locations

  • University of Minnesota Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Cognitive Behavioral Therapy

Wait-list

Arm Description

Weekly Cognitive Behavior therapy

Subjects in wait-list for six-weeks

Outcomes

Primary Outcome Measures

PG-YBOCS

Secondary Outcome Measures

Time spent gambling

Full Information

First Posted
June 14, 2006
Last Updated
January 4, 2010
Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00337753
Brief Title
Cognitive Behavioral Therapy for Pathological Gambling
Official Title
Cognitive Behavioral Therapy for Pathological Gambling
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate a new form of counseling for pathological gambling and to see if the counseling is more effective than attending Gamblers Anonymous.
Detailed Description
Subjects will be assigned to counseling or be given a referral list of available Gamblers Anonymous meetings at the first visit based on answers to questions. Assignment to counseling or Gamblers Anonymous will be randomly selected (i.e. chance) with an equal chance of receiving either one. For those assigned to counseling, you will meet with the therapist for 60 minutes weekly. You will receive 5 sessions of counseling. All subjects will be assessed with gambling questionnaires twice during the 5-week period and again at 3 and 6 months following the 5-week period. For those assigned to Gamblers Anonymous, they will be offered 5 weeks of counseling at the end of the 6-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling
Keywords
Gambling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Weekly Cognitive Behavior therapy
Arm Title
Wait-list
Arm Type
Other
Arm Description
Subjects in wait-list for six-weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
5-weeks of Cognitive Behavioral Therapy
Intervention Type
Behavioral
Intervention Name(s)
Wait-list
Intervention Description
subjects assigned to wait-list condition for six-weeks
Primary Outcome Measure Information:
Title
PG-YBOCS
Time Frame
At each visit prior to and after therapy has been completed
Secondary Outcome Measure Information:
Title
Time spent gambling
Time Frame
At each visit prior to and after therapy has been completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatient men and women age 18 to 75 Presence of current DSM-IV pathological gambling for at least 6 months duration PG is the most problematic psychiatric disorder (in the patient's and clinician's opinion) and the primary reason for seeking treatment Minimum score of >5 on the South Oaks Gambling Screen which reflects gambling severity consistent with pathological gambling Exclusion Criteria: Current clinically significant suicidality, severe depression (a score of ≥ 19 on the Hamilton Rating Scale for Depression, 17-item version)(30) or any other disorder requiring immediate intervention Presence of any clinical features requiring a higher level of care than outpatient treatment Cognitive impairment that interferes with the capacity to engage in CBT or to provide informed consent DSM-IV substance abuse or dependence within the past 3 months (see Screening Visit) Current Axis I diagnosis of bipolar disorder or psychotic disorder Previous treatment of CBT for PG (duration of at least 6 sessions); because CBT is not widely used for PG, a minimum of 6 treatments will be rare. Current use of psychotropic medications or within 2 months prior to study entry. Current participation in Gambler's Anonymous (GA).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD, JD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cognitive Behavioral Therapy for Pathological Gambling

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