NCT02800096

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

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, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

June 8, 2016

Last Update Submit

October 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • The NORC DSM-IV Screen for Gambling Problems (NODS) past 3 month version indicating DSM-IV gambling severity.

    Change in gambling severity (NODS) from baseline

    3 and 6 months

Secondary Outcomes (1)

  • Number of days gambled per month

    3 and 6 months

Study Arms (2)

Gambling Internet intervention

ACTIVE COMPARATOR

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.

Behavioral: Gambling Internet intervention

Gambling Internet intervention + MoodGYM

EXPERIMENTAL

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.

Behavioral: Gambling Internet interventionBehavioral: MoodGYM

Interventions

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.

Gambling Internet interventionGambling Internet intervention + MoodGYM
MoodGYMBEHAVIORAL

Internet intervention for depression and anxiety - MoodGYM, an extensively evaluated intervention found to be effective in a variety of different settings.

Gambling Internet intervention + MoodGYM

Eligibility Criteria

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

You may qualify if:

  • years of age or over
  • Score of 3 or greater on the Problem Gambling Severity Index of the Canadian Problem Gambling Index (PGSI- CPGI)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (3)

  • Najavits LM, Ledgerwood DM, Afifi TO. A Randomized Controlled Trial for Gambling Disorder and PTSD: Seeking Safety and CBT. J Gambl Stud. 2023 Dec;39(4):1865-1884. doi: 10.1007/s10899-023-10224-z. Epub 2023 Jun 12.

  • 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.

Related Links

MeSH Terms

Conditions

GamblingDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersBehavioral Symptoms

Study Officials

  • John A Cunningham, Ph.D.

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 15, 2016

Study Start

June 1, 2016

Primary Completion

August 11, 2017

Study Completion

August 11, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations