Gambling DisorderNCT03614884
Effectiveness of an Online Integrated Treatment for Problem Gambling and Tobacco Smoking
A study testing Gambling and Smoking Treatment and Gambling only treatment in people with Gambling Disorder, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- Gambling and Smoking Treatment and Gambling only treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 3 Sep 2018to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3T 2M8
Matthew Keough, PhD
About this study
Official title: Developing and Testing the Effectiveness of a Novel Online Integrated Treatment for Problem Gambling and Tobacco Smoking: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Gambling Disorder
- Being tested
- Gambling and Smoking Treatment, Gambling only treatment
- Keywords
- gambling, smoking, online intervention, Cognitive Behavioural Therapy, Motivational Interviewing, Randomized Controlled Trial
- Medical subject headings
- Gambling, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gambling and Smoking TreatmentBehavioural
Also called Online CBT and MI
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.
Gambling only treatmentBehavioural
Also called Online CBT and MI
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.
| Study group | Role | What they receive |
|---|---|---|
| Gambling and Smoking Treatment | Experimental | Participants in this arm will be given access to the online integrated treatment for gambling and smoking. Receives: Behavioral: Gambling and Smoking Treatment |
| Gambling Only Treatment | Active comparator | Participants in this arm will be given access to the online gambling only treatment. Receives: Behavioral: Gambling only treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Brief self-report questionnaire with questions about gambling symptoms
Measured: 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
Brief self-report questionnaire with questions about gambling severity
Measured: 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
TLFB designed to assess the number of cigarettes smoked during a 30-day period.
Measured: 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 participants who remained abstinent from smoking in the 30-days prior to each assessment
Measured: 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
Brief self-report questionnaire with questions about nicotine dependence
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start3 Sep 2018
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew T Keough, PhD, Principal investigator, University of ManitobaMichael Schaub, PhD, Principal investigator, University of ZurichSherry H Stewart, PhD, Study chair, Dalhousie UniversityDavid Hodgins, PhD, Study chair, University of CalgaryJames Mackillop, PhD, Study chair, McMaster UniversityR. Michael Bagby, PhD, Study chair, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614884
- Sponsor's protocol ID
- P2018:088 (HS22037)
- Status last verified
- May 2021
- First submitted
- 30 Jul 2018
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33213506
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing the Effectiveness of a Novel Online Integrated Treatment for Problem Gambling and Tobacco Smoking: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03614884
- Acronym / sponsor ID
- P2018:088 (HS22037)
- Conditions
- Gambling Disorder
- Keywords
- gambling, smoking, online intervention, Cognitive Behavioural Therapy, Motivational Interviewing, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gambling and Smoking Treatment | Experimental | Behavioral: Gambling and Smoking TreatmentParticipants in this arm will be given access to the online integrated treatment for gambling and smoking. |
| Gambling Only Treatment | Active comparator | Behavioral: Gambling only treatmentParticipants in this arm will be given access to the online gambling only treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gambling and Smoking TreatmentAlso: Online CBT and MIThe 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. | Behavioural | Gambling and Smoking Treatment |
| Gambling only treatmentAlso: Online CBT and MIThe 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. | Behavioural | Gambling Only Treatment |
Primary outcome
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.
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.
5 secondary outcomes
Gambling symptom assessment
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).
Problem 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).
Cigarette use
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).
Point Prevalence for Abstinence
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).
Nicotine dependence 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Derived from this study: PubMed 33213506Bilevicius 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew T Keough, PhD principal investigator
University of Manitoba
Michael Schaub, PhD principal investigator
University of Zurich
Sherry H Stewart, PhD study chair
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gambling and Smoking Treatment and Gambling only treatment in people with Gambling Disorder, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew T Keough, PhD (204-474-7400, matthew.keough@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614884, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.