Cognitive Behavioral Therapy for Pathological Gambling

Pathological Gambling Clinical Trial

Official title:

Cognitive Behavioral Therapy for Pathological Gambling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337753
• Other study ID #: 0503M68191
• Secondary ID: K23MH069754-01A1
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2006
• Last updated: January 4, 2010
• Start date: June 2006
• Est. completion date: June 2009

Study information

• Verified date: January 2010
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Outpatient men and women age 18 to 75

2. Presence of current DSM-IV pathological gambling for at least 6 months duration

3. PG is the most problematic psychiatric disorder (in the patient's and clinician's opinion) and the primary reason for seeking treatment

4. Minimum score of >5 on the South Oaks Gambling Screen which reflects gambling severity consistent with pathological gambling

Exclusion Criteria:

1. 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

2. Presence of any clinical features requiring a higher level of care than outpatient treatment

3. Cognitive impairment that interferes with the capacity to engage in CBT or to provide informed consent

4. DSM-IV substance abuse or dependence within the past 3 months (see Screening Visit)

5. Current Axis I diagnosis of bipolar disorder or psychotic disorder

6. 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.

7. Current use of psychotropic medications or within 2 months prior to study entry.

8. Current participation in Gambler's Anonymous (GA).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gambling
• Pathological Gambling

Intervention

Behavioral:
• Cognitive Behavioral Therapy
5-weeks of Cognitive Behavioral Therapy
• Wait-list
subjects assigned to wait-list condition for six-weeks

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PG-YBOCS		At each visit prior to and after therapy has been completed	No
Secondary	Time spent gambling		At each visit prior to and after therapy has been completed	No