Minimal and Brief Treatments for Pathological Gamblers | NCT00203645

Studies
Minimal and Brief Treatments for Pathological Gamblers

NCT00203645

Sponsor

University of Calgary

Status

Completed

Last Update Posted

Feb 16, 2009Estimated

Enrollment

312Actual

Phase

Phase 3

Conditions

Pathological Gambling

Interventions

Self-help treatment

Countries

Canada

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
1016 - OPGRC

Status Module

Record Verification Date

Feb 2009

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

Jul 2003

Primary Completion Date

Apr 2006Actual

Completion Date

Feb 2009Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 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

Feb 13, 2009

Last Update Posted Date

Feb 16, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of CalgaryOTHER

Collaborators

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of the study is to examine whether problem gamblers who receive therapy calls in addition to a self-help manual will be more likely to quit or cut back on their gambling when compared with problem gamblers who receive just the manual.

Detailed Description

With gambling becoming more accessible, the occurrence of problems related to gambling are on the rise. The costs of problem gambling are enormous.There are social and economic costs, the gambler can sometimes lose a significant relationship, job, or commit an illegal activity. Pathological gamblers are also at risk for developing a general medical condition related to stress. There is a high risk of suicide and problem gamblers also have increased rates of mental health disorders. Relatively few people choose to attend formal treatment programs so it's important to provide a range of options to make treatment more accessible. The present study examines the effectiveness of minimal and brief interventions delivered by the telephone.

Comparison(s): The "Workbook Only Control" condition involves receiving the self-help booklet through the mail after a brief telephone assessment. The "Minimal Treatment" condition involves receiving the same workbook but also having a motivational enhancement intervention by telephone. The "Brief Treatment" condition provides the workbook, motivational enhancement, and follow-up support on six occasions spread over 36 weeks. The "Wait List Control" condition involves participants being assigned to a six week waiting list. Participants are assessed and after a six week waiting period they will have a reassessment at which time they will be sent the gambling self-help workbook.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

312Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brief self-directed treatment	Experimental	self-help workbook plus motivational telephone intervention	Behavioral: Self-help treatment
Self-directed plus telephone support	Experimental	Self-help workbook, motivational telephone intervention plus telephone booster calls	Behavioral: Self-help treatment
Workbook only	Active Comparator	Workbook only	Behavioral: Self-help treatment
Waitlist	No Intervention	Six week waitlist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Self-help treatment	Behavioral	Workbook "Becoming a Winner",	Brief self-directed treatment Self-directed plus telephone support Workbook only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Days of Gambling		3,6,9 12 months
Money lost		3,6,9 12 months

Secondary Outcomes

Measure	Description	Time Frame
Gambling problem severity		12 months
Psychiatric symptoms		12 months
Self-efficacy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over age 17
Perception of a gambling problem and a score of 3 or higher (moderate risk) on the Canadian Problem Gambling Index.
Not involved in treatment at present.
Willingness to read a short book written in English as a major treatment.
Willing to have telephone contacts recorded.
Willing to provide follow-up data on gambling.
Willing to provide the name of a collateral to help locate them for follow-up interviews.
Must have gambled at least once in the past month

Exclusion Criteria:

Participants in the preliminary study will be excluded.

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
David C Hodgins, PhD.	University of Calgary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Calgary		Calgary	Alberta	T2N 1N4	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11302277	Background	Hodgins DC, Currie SR, el-Guebaly N. Motivational enhancement and self-help treatments for problem gambling. J Consult Clin Psychol. 2001 Feb;69(1):50-7. doi: 10.1037//0022-006x.69.1.50.
15482086	Background	Hodgins DC, Currie S, el-Guebaly N, Peden N. Brief motivational treatment for problem gambling: a 24-month follow-up. Psychol Addict Behav. 2004 Sep;18(3):293-6. doi: 10.1037/0893-164X.18.3.293.

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

ID	Term
D001638	Bibliotherapy
D062405	Motivational Interviewing

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care