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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00118391
Other study ID # R01MH060417-02
Secondary ID R01MH060417-02
Status Completed
Phase Phase 1
First received July 6, 2005
Last updated June 28, 2013
Start date November 2002
Est. completion date October 2005

Study information

Verified date June 2013
Source University of Connecticut Health Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will determine the effectiveness of cognitive behavior therapy (CBT) and contingency management (CM) in reducing gambling behaviors and other related problems in pathological gambling.

Study hypothesis: Participants who receive CBT and CM will attend more treatment sessions and show better outcomes than those who receive CBT alone.


Description:

Pathological gambling has become an increasingly problematic condition in the United States, often causing serious financial, psychological, and public health consequences. In an effort to treat this growing problem, researchers have evaluated numerous therapies; one such therapy is CBT. CBT has been shown to improve pathological gambling outcomes. However, evidence suggests that adding CM to CBT could result in even more improved outcomes. This study will compare the effectiveness of CBT and CM with that of CBT alone in reducing pathological gambling.

This study will last 12 months. Participants will be randomly assigned to receive either CBT and CM or CBT alone for 8 weeks. CBT will focus on reducing gambling urges and helping patients develop alternative behaviors to gambling. CM will focus on encouraging patients to avoid gambling. Participants in the CBT and CM group will receive voucher incentives for completing homework assignments and engaging in non-gambling social activities. The vouchers will allow participants to take part in non-gambling activities of their choice. Changes in gambling activities and problems will be assessed with self-report scales and interviews at study start and at Weeks 10, 24, and 52.

Participants will be asked to identify at least one person who knows about their gambling and will have regular contact with them over the 12 months of the study. This person will be interviewed at study start and at Months 2, 6, and 12. Contact persons will be asked about participants' gambling behaviors, personal relationships, legal problems, use of health care and mental health services, and how the participant can be contacted if he or she moves.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00158314

http://clinicaltrials.gov/show/NCT00618462


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of pathological gambling

- At least 1 gambling episode within 30 days prior to study entry

- Able to read English at a 5th grade level

- Willing and able to comply with all study requirements

Exclusion Criteria:

- Uncontrolled psychiatric conditions

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive behavior therapy
Receive 8 50-minute sessions of one-on-one cognitive behavioral therapy
Contingency management
Receive vouchers that can be spent on rewards for completing activities that support abstinence from gambling

Locations

Country Name City State
United States University of Connecticut Health Center Farmington Connecticut

Sponsors (2)

Lead Sponsor Collaborator
University of Connecticut Health Center National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Addiction Severity Index (ASI) gambling severity scores
Primary amount spent gambling per gambling episode
Primary longest period of non-gambling
Primary days until first gambling episode
Primary percent of days gambling
Primary proportion meeting diagnostic criteria
Primary number of treatment sessions attended
Secondary Psychosocial functioning
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