- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02800096
Online Interventions for Gamblers With and Without Co-occurring Mental Health Concerns
October 24, 2017 updated by: John Cunningham, Centre for Addiction and Mental Health
Online Interventions for Problem Gamblers With and Without Co-occurring Mental Health Concerns: Randomized Controlled Trial
Comorbidity between problem gambling and mental health concerns such as anxiety and depression is common.
Further, the treatment needs of people with co-occurring gambling and mental health concerns may be different from those of problem gamblers who do not have a co-occurring mental health concern.
The present study is a two-arm, double blinded, parallel group randomized controlled trial (RCT) that will evaluate whether there is a benefit to providing access to mental health Internet interventions (G+MH intervention) in addition to an Internet intervention for problem gambling (G-only intervention) in participants with gambling problems who do or do not have co-occurring mental health concerns.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
People with gambling concerns will be recruited using targeted advertisements.
Potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling.
As part of the baseline screening process, measures of current depression and anxiety will be assessed.
Eligible participants agreeing to take part in the study will be randomized to one of two versions of an online intervention for gamblers - an intervention that just targets gambling issues (G-only) versus one that contains interventions for anxiety and depression in addition to an intervention for gamblers (G+MH).
It is predicted that problem gamblers who do not have co-occurring mental health concerns will display no significant difference between intervention conditions at a six-month follow-up.
However, for those with co-occurring mental health concerns, it is predicted that participants receiving access to G+MH website will display significantly reduced gambling outcomes at six-month follow-up as compared to those provided with G-only website.
Study Type
Interventional
Enrollment (Actual)
284
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or over
- Score of 3 or greater on the Problem Gambling Severity Index of the Canadian Problem Gambling Index (PGSI- CPGI)
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Gambling Internet intervention
The gambling only Internet intervention (G-only) will consist of a new online version of self-change tools that have previously been translated successfully into an online form and shown to have a significant impact on gambling in three trials.
A major focus of this intervention is to provide individuals with clear and concise behavioral and cognitive strategies for meeting the goal of reducing or quitting gambling.
|
The gambling Internet intervention consists of a new online version of self-change tools that have previously been translated successfully into an online form and shown to have a significant impact on gambling in three trials.
A major focus of this intervention is to provide individuals with clear and concise behavioral and cognitive strategies for meeting the goal of reducing or quitting gambling.
|
Experimental: Gambling Internet intervention + MoodGYM
The G+MH intervention condition will consist of the G-only intervention and an online intervention for depression and anxiety.
The mental health intervention chosen is MoodGYM, an extensively evaluated intervention found to be effective in a variety of different settings.
|
The gambling Internet intervention consists of a new online version of self-change tools that have previously been translated successfully into an online form and shown to have a significant impact on gambling in three trials.
A major focus of this intervention is to provide individuals with clear and concise behavioral and cognitive strategies for meeting the goal of reducing or quitting gambling.
Internet intervention for depression and anxiety - MoodGYM, an extensively evaluated intervention found to be effective in a variety of different settings.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The NORC DSM-IV Screen for Gambling Problems (NODS) past 3 month version indicating DSM-IV gambling severity.
Time Frame: 3 and 6 months
|
Change in gambling severity (NODS) from baseline
|
3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days gambled per month
Time Frame: 3 and 6 months
|
Change in mean days per month gambling from baseline
|
3 and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cunningham JA, Hodgins DC, Mackenzie CS, Godinho A, Schell C, Kushnir V, Hendershot CS. Randomized controlled trial of an Internet intervention for problem gambling provided with or without access to an Internet intervention for co-occurring mental health distress. Internet Interv. 2019 Mar 6;17:100239. doi: 10.1016/j.invent.2019.100239. eCollection 2019 Sep.
- Cunningham JA, Hodgins DC, Bennett K, Bennett A, Talevski M, Mackenzie CS, Hendershot CS. Online interventions for problem gamblers with and without co-occurring mental health symptoms: Protocol for a randomized controlled trial. BMC Public Health. 2016 Jul 22;16:624. doi: 10.1186/s12889-016-3291-7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
August 11, 2017
Study Completion (Actual)
August 11, 2017
Study Registration Dates
First Submitted
June 8, 2016
First Submitted That Met QC Criteria
June 10, 2016
First Posted (Estimate)
June 15, 2016
Study Record Updates
Last Update Posted (Actual)
October 25, 2017
Last Update Submitted That Met QC Criteria
October 24, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 004/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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