- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03614884
Effectiveness of an Online Integrated Treatment for Problem Gambling and Tobacco Smoking
Developing and Testing the Effectiveness of a Novel Online Integrated Treatment for Problem Gambling and Tobacco Smoking: A Randomized Controlled Trial
Research has shown that problem gambling and tobacco smoking are highly comorbid. Problem gamblers who smoke tend to: have more severe gambling problems, experience stronger gambling urges, have other mental disorders, bet larger sums of money, spend more time in gambling activities, and have greater financial problems. Accordingly, it might be helpful to reduce your smoking as well, while you are trying to get a grip on your gambling.
Previous studies have treated gambling on its own or tobacco smoking on its own. To date, there has not been a treatment that has targeted treating both at the same time. Considering how often these conditions occur together, it is important to see if combining their treatment results in beneficial outcomes. In the current research, the researchers aim to design and test an online, self-help intervention for co-occurring problem gambling and tobacco smoking. It will draw on strategies from Cognitive Behavioural Therapy (CBT) and Motivational Interviewing (MI) - both which have been shown to be successful in treating problem gambling and tobacco smoking. These outcomes will be compared to a group that receives treatment for problem gambling only. This research will provide insight into a potential new intervention for treating two highly co-occurring conditions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The researchers are hoping to recruit 300 participants for this study. Half (150) of these individuals will receive the integrated treatment, where both gambling and smoking behaviours will be addressed. Those in the integrated group will be encouraged to use nicotine replacement therapy (NRT) in the form of nicotine patches. These patches will be provided to participants at the beginning of the intervention and will be encouraged to use for the duration of the 8-weeks. The the other half of the participants (150) will receive the problem gambling treatment only.
Once participants provided informed consent and are registered on the treatment website, they will be asked to complete a baseline assessment in order to determine eligibility. Eligible participants will be those that: are aged 19 years old+, have at least moderate levels of gambling, report current daily smoking, are fluent in English, have weekly internet access, and report at least moderate motivation to change gambling and/or smoking behaviours.
Once the link is available, participants will complete the online, self-help 8-week treatment. At the end of the program, they will complete the same brief questionnaires. Six months following the completion of the online program, they will complete the same series of brief questionnaires.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matthew T Keough, PhD
- Phone Number: 204-474-7400
- Email: matthew.keough@umanitoba.ca
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3T 2M8
- Recruiting
- University of Manitoba
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Contact:
- Matthew Keough, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ages 19+
- problem gambling status based on reporting a score of > 3 on the Problem Gambling Severity Index
- reporting current daily smoking
- fluency in English
- have weekly Internet access
- report at least moderate motivation to change gambling and/or smoking behaviours
Exclusion Criteria:
- Those that are identified as "Higher" risk on the suicide screener
- self-reported engagement in other psychosocial treatments for problem gambling and/or smoking
- past-90 day psychosis or mania
- presence of a severe substance use disorder (SUD) (For alcohol, individuals with a score of > 20 on the Alcohol Use Disorder Identification Test (AUDIT) will be excluded from the study. For substance use, individuals with a score of > 5 on the Drug Abuse Screening Test-10 (DAST-10) will be excluded).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Gambling and Smoking Treatment
Participants in this arm will be given access to the online integrated treatment for gambling and smoking.
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The treatment condition will have access to 7 treatment modules on content surrounding both gambling and smoking behaviours.
Participants will have 8-weeks to complete them.
The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing.
Through module engagement, participants will identify goals related to gambling and smoking behaviours, learn strategies to cope with cravings and triggers, and learn how to prevent relapse.
Participants will have immediate access to all modules, and it will be recommended that they work through the modules sequentially.
Participants in this condition will also be provided with nicotine replacement therapy (NRT) in the form of nicotine patches to use for the duration of the study.
Other Names:
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ACTIVE_COMPARATOR: Gambling Only Treatment
Participants in this arm will be given access to the online gambling only treatment.
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The control condition will have access to 7 treatment modules on content surrounding gambling only.
Participants will have 8-weeks to complete them.
The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing.
Through module engagement, participants will identify goals related to gambling behaviours, learn strategies to cope with cravings and triggers, and learn how to prevent relapse.
Participants will have immediate access to all modules, and it will be recommended that they work through the modules sequentially.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in number of days gambled
Time Frame: Participants will be assessed using the TLFB at three time points: at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
|
Timeline Follow-Back (TLFB; Sobell & Sobell, 1992) - designed to assess the number of days gambled during a 30-day period.
The TLFB has been shown to provide reliable and valid estimates of gambling behaviour, and is widely used in basic and treatment studies.
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Participants will be assessed using the TLFB at three time points: at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
|
|
Change in money spent gambling
Time Frame: Participants will be assessed using the TLFB at three time points: at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
|
TLFB designed to assess money (in dollars) spent gambling during a 30-day period.
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Participants will be assessed using the TLFB at three time points: at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
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Change in time spent gambling
Time Frame: Participants will be assessed using the TLFB at three time points: at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
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TLFB designed to assess the time spent gambling (in minutes) during a 30-day period.
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Participants will be assessed using the TLFB at three time points: at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gambling symptom assessment
Time Frame: Change in score from beginning of program (baseline T0) at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
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Brief self-report questionnaire with questions about gambling symptoms
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Change in score from beginning of program (baseline T0) at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
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Problem gambling severity
Time Frame: Change in score from beginning of program (baseline T0) at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
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Brief self-report questionnaire with questions about gambling severity
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Change in score from beginning of program (baseline T0) at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
|
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Cigarette use
Time Frame: Participants will be assessed using the TLFB at three time points: at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
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TLFB designed to assess the number of cigarettes smoked during a 30-day period.
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Participants will be assessed using the TLFB at three time points: at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
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Point Prevalence for Abstinence
Time Frame: Percentage of people at baseline (T0),immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
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Percentage of participants who remained abstinent from smoking in the 30-days prior to each assessment
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Percentage of people at baseline (T0),immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
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Nicotine dependence symptoms
Time Frame: Change in score from beginning of program (baseline T0) at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
|
Brief self-report questionnaire with questions about nicotine dependence
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Change in score from beginning of program (baseline T0) at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew T Keough, PhD, University of Manitoba
- Principal Investigator: Michael Schaub, PhD, University of Zurich
- Study Chair: Sherry H Stewart, PhD, Dalhousie University
- Study Chair: David Hodgins, PhD, University Of Calgary
- Study Chair: James Mackillop, PhD, McMaster University
- Study Chair: R. Michael Bagby, PhD, University of Toronto
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2018:088 (HS22037)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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