Effectiveness of an Online Integrated Treatment for Problem Gambling and Tobacco Smoking
Primary Purpose
Gambling Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gambling and Smoking Treatment
Gambling only treatment
Sponsored by
About this trial
This is an interventional treatment trial for Gambling Disorder focused on measuring gambling, smoking, online intervention, Cognitive Behavioural Therapy, Motivational Interviewing, Randomized Controlled Trial
Eligibility Criteria
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).
Sites / Locations
- University of ManitobaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gambling and Smoking Treatment
Gambling Only Treatment
Arm Description
Participants in this arm will be given access to the online integrated treatment for gambling and smoking.
Participants in this arm will be given access to the online gambling only treatment.
Outcomes
Primary Outcome Measures
Change in number of days gambled
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.
Change in money spent gambling
TLFB designed to assess money (in dollars) spent gambling during a 30-day period.
Change in time spent gambling
TLFB designed to assess the time spent gambling (in minutes) during a 30-day period.
Secondary Outcome Measures
Gambling symptom assessment
Brief self-report questionnaire with questions about gambling symptoms
Problem gambling severity
Brief self-report questionnaire with questions about gambling severity
Cigarette use
TLFB designed to assess the number of cigarettes smoked during a 30-day period.
Point Prevalence for Abstinence
Percentage of participants who remained abstinent from smoking in the 30-days prior to each assessment
Nicotine dependence symptoms
Brief self-report questionnaire with questions about nicotine dependence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03614884
Brief Title
Effectiveness of an Online Integrated Treatment for Problem Gambling and Tobacco Smoking
Official Title
Developing and Testing the Effectiveness of a Novel Online Integrated Treatment for Problem Gambling and Tobacco Smoking: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder
Keywords
gambling, smoking, online intervention, Cognitive Behavioural Therapy, Motivational Interviewing, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A two-arm randomized controlled trial (RCT) will be conducted to evaluate the proposed online intervention. Eligible participants will be randomized to either the online integrated gambling and smoking treatment condition, or the gambling only (i.e., control) condition.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gambling and Smoking Treatment
Arm Type
Experimental
Arm Description
Participants in this arm will be given access to the online integrated treatment for gambling and smoking.
Arm Title
Gambling Only Treatment
Arm Type
Active Comparator
Arm Description
Participants in this arm will be given access to the online gambling only treatment.
Intervention Type
Behavioral
Intervention Name(s)
Gambling and Smoking Treatment
Other Intervention Name(s)
Online CBT and MI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gambling only treatment
Other Intervention Name(s)
Online CBT and MI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in number of days gambled
Description
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.
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).
Title
Change in money spent gambling
Description
TLFB designed to assess money (in dollars) spent gambling during a 30-day period.
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).
Title
Change in time spent gambling
Description
TLFB designed to assess the time spent gambling (in minutes) during a 30-day period.
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).
Secondary Outcome Measure Information:
Title
Gambling symptom assessment
Description
Brief self-report questionnaire with questions about gambling 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).
Title
Problem gambling severity
Description
Brief self-report questionnaire with questions about 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).
Title
Cigarette use
Description
TLFB designed to assess the number of cigarettes smoked during a 30-day period.
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).
Title
Point Prevalence for Abstinence
Description
Percentage of participants who remained abstinent from smoking in the 30-days prior to each assessment
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).
Title
Nicotine dependence symptoms
Description
Brief self-report questionnaire with questions about nicotine dependence
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew T Keough, PhD
Phone
204-474-7400
Email
matthew.keough@umanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew T Keough, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Schaub, PhD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherry H Stewart, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Hodgins, PhD
Organizational Affiliation
University of Calgary
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James Mackillop, PhD
Organizational Affiliation
McMaster University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
R. Michael Bagby, PhD
Organizational Affiliation
University of Toronto
Official's Role
Study Chair
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2M8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Keough, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33213506
Citation
Bilevicius E, Single A, Baumgartner C, Bui V, Kempe T, Schaub MP, Stewart SH, MacKillop J, Hodgins DC, Wardell JD, O'Connor R, Read J, Hadjistavropoulos H, Sundstrom C, Keough MT. Developing and testing the effectiveness of a novel online integrated treatment for problem gambling and tobacco smoking: a protocol for an open-label randomized controlled trial. Trials. 2020 Nov 19;21(1):937. doi: 10.1186/s13063-020-04867-1.
Results Reference
derived
Learn more about this trial
Effectiveness of an Online Integrated Treatment for Problem Gambling and Tobacco Smoking
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