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
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedStudy Start
First participant enrolled
September 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMay 12, 2021
May 1, 2021
2.9 years
July 30, 2018
May 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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
TLFB designed to assess money (in dollars) spent gambling during a 30-day period.
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 time spent gambling
TLFB designed to assess the time spent gambling (in minutes) during a 30-day period.
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 Outcomes (5)
Gambling symptom assessment
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).
Problem gambling severity
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).
Cigarette use
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).
Point Prevalence for Abstinence
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).
Nicotine dependence symptoms
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).
Study Arms (2)
Gambling and Smoking Treatment
EXPERIMENTALParticipants in this arm will be given access to the online integrated treatment for gambling and smoking.
Gambling Only Treatment
ACTIVE COMPARATORParticipants in this arm will be given access to the online gambling only treatment.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Manitoba
Winnipeg, Manitoba, R3T 2M8, Canada
Related Publications (1)
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.
PMID: 33213506DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2018
First Posted
August 3, 2018
Study Start
September 3, 2018
Primary Completion
August 1, 2021
Study Completion
December 1, 2021
Last Updated
May 12, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share