Gambling and Brief Interventions | NCT00183599

Studies
Gambling and Brief Interventions

NCT00183599

Sponsor

UConn Health

Status

Completed

Last Update Posted

Apr 9, 2019Actual

Enrollment

500

Phase

Not Applicable

Conditions

Gambling

Interventions

5 Minutes of Simple Advice
Motivational Enhancement Therapy (MET)
Cognitive Behavioral Therapy (CBT)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DF#00-121

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1999

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2019

Last Update Posted Date

Apr 9, 2019Actual

Name	Class
Donaghue Medical Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will compare four different combinations and durations of motivational enhancement therapy, cognitive behavioral therapy, and brief advice treatments for gambling versus a non-intervention condition to determine which is most effective in reducing problem gambling.

Detailed Description

Gambling, if done compulsively, can cause psychological, physical, social, and vocational problems. Problem gambling, or compulsive gambling, is a progressive addiction characterized by a preoccupation with gambling, a need to bet more money more frequently, restlessness or irritability when attempting to stop, and gambling more to make up for losses. This study will compare four different combinations and durations of motivational enhancement therapy (MET), cognitive behavioral therapy (CBT), and brief advice treatments for gambling versus a non-intervention condition to determine which is most effective in reducing problem gambling.

This open-label study will last a total of 9 months. Participants will be randomly assigned to one of four groups. Group 1 will have no intervention and will be instructed to call if they experience any gambling problems. Group 2 will receive 5 minutes of education on the hazards of heavy gambling. In addition, they will receive a 1-page brochure on problem gambling and its consequences. Group 3 will receive a 1-hour session of MET focused on increasing commitment to change by raising awareness of personal consequences of gambling. Group 4 will receive the same MET session as Group 3, as well as three 1-hour sessions of CBT focused on identifying specific social and mood cues associated with gambling. Treatment will end at Week 4. Participants will have two follow-up sessions held over the phone at Week 6 and again 9 months after enrollment. Gambling behavior, employment status, alcohol and drug use, psychiatric problems, and family problems will be assessed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Behavioral: 5 Minutes of Simple Advice
2	Experimental	Behavioral: Motivational Enhancement Therapy (MET)
3	Experimental	Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5 Minutes of Simple Advice	Behavioral		1
Motivational Enhancement Therapy (MET)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Addiction Severity Index (ASI)-gambling severity scores		measured at baseline, Week 6, and 9 months
Amount spent gambling		measured at baseline, Week 6, and 9 months
Days gambled		measured at baseline, Week 6, and 9 months
Proportion meeting problem gambling criteria		measured at baseline, Week 6, and 9 months
Proportion abstinent		measured at baseline, Week 6, and 9 months

Secondary Outcomes

Measure	Description	Time Frame
Psychosocial functioning		measured at baseline, Week 6, and 9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meets criteria for problem gambling
Two or more gambling episodes per month for 2 months prior to enrollment
Has spent at least $50 per month on gambling for 2 months prior to enrollment

Exclusion Criteria:

Any uncontrolled psychiatric conditions
Severe cognitive impairment
Currently receiving treatment for gambling

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nancy M Petry, PhD	UConn Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LMG		Bridgeport	Connecticut	06604	United States
University of Connecticut Health Center

Condition Browse Module

MeSH Terms

ID	Term
D005715	Gambling

Ancestor Terms

ID	Term
D012309	Risk-Taking
D001519	Behavior
D007174	Disruptive, Impulse Control, and Conduct Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062405	Motivational Interviewing
D015928	Cognitive Behavioral Therapy

Ancestor Terms

ID	Term
D037001	Directive Counseling
D003376	Counseling
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided