NCT00337753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 5, 2010

Status Verified

January 1, 2010

Enrollment Period

3 years

First QC Date

June 14, 2006

Last Update Submit

January 4, 2010

Conditions

Keywords

Gambling

Outcome Measures

Primary Outcomes (1)

  • PG-YBOCS

    At each visit prior to and after therapy has been completed

Secondary Outcomes (1)

  • Time spent gambling

    At each visit prior to and after therapy has been completed

Study Arms (2)

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Weekly Cognitive Behavior therapy

Behavioral: Cognitive Behavioral Therapy

Wait-list

OTHER

Subjects in wait-list for six-weeks

Behavioral: Wait-list

Interventions

5-weeks of Cognitive Behavioral Therapy

Also known as: CBT
Cognitive Behavioral Therapy
Wait-listBEHAVIORAL

subjects assigned to wait-list condition for six-weeks

Wait-list

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Gambling

Interventions

Cognitive Behavioral TherapyWaiting Lists

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesAppointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Jon E Grant, MD, JD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 16, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 5, 2010

Record last verified: 2010-01

Locations