- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00337753
Cognitive Behavioral Therapy for Pathological Gambling
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55454
- University of Minnesota Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cognitive Behavioral Therapy
Weekly Cognitive Behavior therapy
|
5-weeks of Cognitive Behavioral Therapy
Other Names:
|
|
Other: Wait-list
Subjects in wait-list for six-weeks
|
subjects assigned to wait-list condition for six-weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PG-YBOCS
Time Frame: At each visit prior to and after therapy has been completed
|
At each visit prior to and after therapy has been completed
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time spent gambling
Time Frame: At each visit prior to and after therapy has been completed
|
At each visit prior to and after therapy has been completed
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0503M68191
- K23MH069754-01A1 (U.S. NIH Grant/Contract)
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