Clinical trial NCT03614884: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gambling Disorder
Keywords: gambling
smoking
online intervention
Cognitive Behavioural Therapy
Motivational Interviewing
Randomized Controlled Trial
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in number of days gambled
timeFrame: 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).
measure: Change in money spent gambling
timeFrame: 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).
measure: Change in time spent gambling
timeFrame: 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:
measure: Gambling symptom assessment
timeFrame: 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).
measure: Problem gambling severity
timeFrame: 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).
measure: Cigarette use
timeFrame: 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).
measure: Point Prevalence for Abstinence
timeFrame: 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).
measure: Nicotine dependence symptoms
timeFrame: 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).
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Matthew T Keough, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Michael Schaub, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Sherry H Stewart, PhD
role: STUDY_CHAIR
affiliation: University of Calgary
name: David Hodgins, PhD
role: STUDY_CHAIR
affiliation: McMaster University
name: James Mackillop, PhD
role: STUDY_CHAIR
affiliation: University of Toronto
name: R. Michael Bagby, PhD
role: STUDY_CHAIR
References:
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.