Effectiveness of an Online Integrated Treatment for Problem Gambling and Tobacco Smoking

Sponsor
University of Manitoba (Other)
Overall Status
Recruiting
CT.gov ID
NCT03614884
Collaborator
(none)
300
1
2
38.9
7.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gambling and Smoking Treatment
  • Behavioral: Gambling only treatment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Developing and Testing the Effectiveness of a Novel Online Integrated Treatment for Problem Gambling and Tobacco Smoking: A Randomized Controlled Trial
Actual Study Start Date :
Sep 3, 2018
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gambling and Smoking Treatment

Participants in this arm will be given access to the online integrated treatment for gambling and smoking.

Behavioral: Gambling and Smoking Treatment
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:
  • Online CBT and MI
  • Active Comparator: Gambling Only Treatment

    Participants in this arm will be given access to the online gambling only treatment.

    Behavioral: Gambling only treatment
    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:
  • Online CBT and MI
  • Outcome Measures

    Primary Outcome Measures

    1. Change in number of days gambled [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.

    2. Change in money spent gambling [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.

    3. Change in time spent gambling [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 the time spent gambling (in minutes) during a 30-day period.

    Secondary Outcome Measures

    1. 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).]

      Brief self-report questionnaire with questions about gambling symptoms

    2. 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).]

      Brief self-report questionnaire with questions about gambling severity

    3. 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).]

      TLFB designed to assess the number of cigarettes smoked during a 30-day period.

    4. 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).]

      Percentage of participants who remained abstinent from smoking in the 30-days prior to each assessment

    5. 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).]

      Brief self-report questionnaire with questions about nicotine dependence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Manitoba Winnipeg Manitoba Canada R3T 2M8

    Sponsors and Collaborators

    • University of Manitoba

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Manitoba
    ClinicalTrials.gov Identifier:
    NCT03614884
    Other Study ID Numbers:
    • P2018:088 (HS22037)
    First Posted:
    Aug 3, 2018
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Manitoba
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 12, 2021