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Clinical Trials/NCT03614884
NCT03614884
Unknown
Not Applicable

Developing and Testing the Effectiveness of a Novel Online Integrated Treatment for Problem Gambling and Tobacco Smoking: A Randomized Controlled Trial

University of Manitoba1 site in 1 country300 target enrollmentSeptember 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gambling Disorder
Sponsor
University of Manitoba
Enrollment
300
Locations
1
Primary Endpoint
Change in time spent gambling
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 3, 2018
End Date
December 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

Outcomes

Primary Outcomes

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).

TLFB designed to assess the time spent gambling (in minutes) during a 30-day period.

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.

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.

Secondary Outcomes

  • 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).)
  • 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).)
  • 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).)
  • 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).)
  • 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).)

Study Sites (1)

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