Gambling DisorderNCT03493399
Testing Interference-based Methods to Mitigate Gambling Craving - A Multiple Single Case Design
A study testing Interference in people with Gambling Disorder and Gambling, Pathological, run by Université Catholique de Louvain at 1 site in Switzerland.
Trial summary
Gambling craving is involved in the development, maintenance and relapse of gambling disorder. Yet, it lacks research regarding evidence-based interventions available to mitigate craving in patients displaying gambling disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling Disorder, Gambling, Pathological, Craving
- What is being tested?
- Interference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2019to 30 Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients from CJE
- In therapy for a Gambling Disorder
- French speaking
- Signifiant gambling cravings (clinically assessed)
- Sign an inform consent
Who cannot join
- Comorbidities (psychosis, acute manic phase, acute depressive phase, suicidal phase, mental retardation, alcohol intoxication or other psychic state incompatible with the study)
Trial locations and contacts
1 site in 1 country.
Olivier Simon contact
Switzerland1 site
Centre du Jeu Excessif
Lausanne, Canton of Vaud
Olivier Simon, olivier.simon@chuv.ch
About this study
Gambling craving is involved in the development, maintenance and relapse of gambling disorder. Yet, it lacks research regarding evidence-based interventions available to mitigate craving in patients displaying gambling disorder. The elaborated intrusion theory of desire (EIT) is a cognitive model of craving which offers important avenues for the development of psychological interventions, as it clearly describes the processes at play in craving experiences (e.g., mental imageries, working memory). Recent research evidenced that the elaborated intrusion theory is relevant to account for gambling craving experiences. According to this model, craving (and desire) is the result of an elaboration process where "desires thoughts" (mental images and thoughts), induced by internal (e.g., frustration) and/or external (e.g., advertisement) triggers, require attentional and cognitive resources. The principle of interference-based techniques is to move the resources allocated to the elaboration of intrusive desire thoughts to a competing task (e.g., clay modelling, competitive mental imagery, Tetris) in order to monopolize the resources underlying craving, thus preventing its elaboration and reducing its vividness and overwhelming nature. Several studies have shown the efficacy of such techniques to reduce substance-related craving. Yet, data obtained on clinical samples remain scarce.
Preliminary data have been obtained prior to this application. In order to investigate the relevance of interference-based techniques, an experimental study was conducted in community gamblers. In two conditions (19 gamblers per condition), gambling craving was first induced via a short mental imagery session and a computer-generated gambling simulation task. Then, the experimental group was asked to perform an interference task consisting of creating a vivid mental image of a bunch of keys. The control group completed a task in which they had to pop and count bubble wrap. The analyses revealed that induced craving decreases significantly in both groups. However, participants that are considered problem gamblers showed a greater decrease of their craving in the experimental condition. This previous "proof of principle" study supports that interference-based techniques are potentially promising interventions to reduce craving in problem gambling. It also warrants further research as no data is available in clinical population.
The current project consists in a pilot study aiming to test the efficacy of interference-based techniques in a sample of gambling disorder patients. The investigators decided to adopt a multiple single case design, as this methodology is ideal in the sense that it helps to understand the whole process of an interference-based intervention among a small number (10) of outpatients with a gambling disorder, without control group. Ecological Momentary Assessment will be used to allow intervention no naturally occuring craving. In addition to be easily implementable in a clinical design, this design will provide sufficient evidences before possibly, in a second time, further validation of these techniques using a randomized-control trial.
- Conditions
- Gambling Disorder, Gambling, Pathological, Craving, Gambling, Gambling Problem
- Being tested
- Interference
- Keywords
- Gambling, Craving, Urge, Desire, Interference, Elaborated Intrusion Theory, Treatment, Intervention, Clinical Sample, Single case
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterferenceBehavioural
The principle of interference-based techniques is to move the resources allocated to the elaboration of intrusive desire thoughts to a competing task (e.g., clay modelling, competitive mental imagery, Tetris) in order to monopolize the resources underlying craving, thus preventing its elaboration and reducing its vividness and overwhelming nature. Several studies (Andrade, Pears, May, \& Kavanagh, 2012; May, Andrade, Panabokke, \& Kavanagh, 2010; Skorka-Brown, Andrade, Whalley, \& May, 2015) have shown the efficacy of such techniques to reduce substance-related craving. Yet, data obtained on clinical samples remain scarce.
Due to the flexibility of the single case design towards each participant, the list of interference-based techniques that will be used in this study cannot be exhaustive. However, the following will be proposed to participants: Tetris (smartphone version), manipulation of a bunch of keys, manipulation of a fidget, mental imagery, reading and memorizing a text.
| Study group | Role | What they receive |
|---|---|---|
| Problem Gamblers | Experimental | Interference Receives: Behavioral: Interference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gambling Craving Strength
Self-reported Questionnaire: gambling Craving Experience Questionnaire Strength (g-CEQ-S; Cornil et al., in prep) with 9 items rated on a Likert scale from 0 (not at all) to 10 (extremely). It is divided in 3 subscales of 3 items each: intensity, imagery, intrusiveness.
Measured: 6 months
Gambling Craving Frequency
Self-reported Questionnaire: gambling Craving Experience Questionnaire Frequency (g-CEQ-F; Cornil et al., in prep) with 9 items rated on a Likert scale from 0 (not at all) to 10 (constantly). It is divided in 3 subscales of 3 items each: intensity, imagery, intrusiveness.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Jul 2019 (estimated)
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- University of Luxembourg, Centre Hospitalier Universitaire Vaudois, University of Geneva, Switzerland, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Responsible party
- Principal investigator, Aurelien Cornil, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493399
- Sponsor's protocol ID
- UCLouvain - CJE-CHUV
- Status last verified
- Jun 2019
- First submitted
- 23 Mar 2018
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Young MM, Wohl MJ. The Gambling Craving Scale: Psychometric validation and behavioral outcomes. Psychol Addict Behav. 2009 Sep;23(3):512-22. doi: 10.1037/a0015043.
PubMed 19769435Kavanagh DJ, Andrade J, May J. Imaginary relish and exquisite torture: the elaborated intrusion theory of desire. Psychol Rev. 2005 Apr;112(2):446-67. doi: 10.1037/0033-295X.112.2.446.
PubMed 15783293Cornil, A., Lopez-Fernandez, O., Devos, G., de Timary, P., Goudriaan, A. E., & Billieux, J. (2018). Exploring gambling craving through the elaborated intrusion theory of desire: a mixed methods approach. International Gambling Studies, 18(1), 1-21. https://doi.org/10.1080/14459795.2017.1368686
May J, Andrade J, Panabokke N, Kavanagh D. Visuospatial tasks suppress craving for cigarettes. Behav Res Ther. 2010 Jun;48(6):476-85. doi: 10.1016/j.brat.2010.02.001. Epub 2010 Feb 7.
PubMed 20189549Andrade J, Pears S, May J, Kavanagh DJ. Use of a clay modeling task to reduce chocolate craving. Appetite. 2012 Jun;58(3):955-63. doi: 10.1016/j.appet.2012.02.044. Epub 2012 Feb 24.
PubMed 22369958Skorka-Brown J, Andrade J, Whalley B, May J. Playing Tetris decreases drug and other cravings in real world settings. Addict Behav. 2015 Dec;51:165-70. doi: 10.1016/j.addbeh.2015.07.020. Epub 2015 Jul 26.
PubMed 26275843Cornil, A., & Billieux, J. (2017). OP-15. Using interference-based intervention to block gambling craving: A proof of principle study. Journal of Behavioral Addictions, 6 (Suppl.1), 9.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Interference-based Methods to Mitigate Gambling Craving - A Multiple Single Case Design
- ClinicalTrials.gov ID
- NCT03493399
- Acronym / sponsor ID
- UCLouvain - CJE-CHUV
- Conditions
- Gambling Disorder, Gambling, Pathological, Craving, Gambling, Gambling Problem
- Keywords
- Gambling, Craving, Urge, Desire, Interference, Elaborated Intrusion Theory, Treatment, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- University of Luxembourg, Centre Hospitalier Universitaire Vaudois, University of Geneva, Switzerland, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 10 Apr 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.
Gambling craving is involved in the development, maintenance and relapse of gambling disorder. Yet, it lacks research regarding evidence-based interventions available to mitigate craving in patients displaying gambling disorder. The elaborated intrusion theory of desire (EIT) is a cognitive model of craving which offers important avenues for the development of psychological interventions, as it clearly describes the processes at play in craving experiences (e.g., mental imageries, working memory). Recent research evidenced that the elaborated intrusion theory is relevant to account for gambling craving experiences. According to this model, craving (and desire) is the result of an elaboration process where "desires thoughts" (mental images and thoughts), induced by internal (e.g., frustration) and/or external (e.g., advertisement) triggers, require attentional and cognitive resources. The principle of interference-based techniques is to move the resources allocated to the elaboration of intrusive desire thoughts to a competing task (e.g., clay modelling, competitive mental imagery, Tetris) in order to monopolize the resources underlying craving, thus preventing its elaboration and reducing its vividness and overwhelming nature. Several studies have shown the efficacy of such techniques to reduce substance-related craving. Yet, data obtained on clinical samples remain scarce.
Preliminary data have been obtained prior to this application. In order to investigate the relevance of interference-based techniques, an experimental study was conducted in community gamblers. In two conditions (19 gamblers per condition), gambling craving was first induced via a short mental imagery session and a computer-generated gambling simulation task. Then, the experimental group was asked to perform an interference task consisting of creating a vivid mental image of a bunch of keys. The control group completed a task in which they had to pop and count bubble wrap. The analyses revealed that induced craving decreases significantly in both groups. However, participants that are considered problem gamblers showed a greater decrease of their craving in the experimental condition. This previous "proof of principle" study supports that interference-based techniques are potentially promising interventions to reduce craving in problem gambling. It also warrants further research as no data is available in clinical population.
The current project consists in a pilot study aiming to test the efficacy of interference-based techniques in a sample of gambling disorder patients. The investigators decided to adopt a multiple single case design, as this methodology is ideal in the sense that it helps to understand the whole process of an interference-based intervention among a small number (10) of outpatients with a gambling disorder, without control group. Ecological Momentary Assessment will be used to allow intervention no naturally occuring craving. In addition to be easily implementable in a clinical design, this design will provide sufficient evidences before possibly, in a second time, further validation of these techniques using a randomized-control trial.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Problem Gamblers | Experimental | Behavioral: InterferenceInterference |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients from CJE
- In therapy for a Gambling Disorder
- French speaking
- Signifiant gambling cravings (clinically assessed)
- Sign an inform consent
Key exclusion criteria (1 listed)
- Comorbidities (psychosis, acute manic phase, acute depressive phase, suicidal phase, mental retardation, alcohol intoxication or other psychic state incompatible with the study)
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 |
|---|---|---|
| InterferenceThe principle of interference-based techniques is to move the resources allocated to the elaboration of intrusive desire thoughts to a competing task (e.g., clay modelling, competitive mental imagery, Tetris) in order to monopolize the resources underlying craving, thus preventing its elaboration and reducing its vividness and overwhelming nature. Several studies (Andrade, Pears, May, \& Kavanagh, 2012; May, Andrade, Panabokke, \& Kavanagh, 2010; Skorka-Brown, Andrade, Whalley, \& May, 2015) have shown the efficacy of such techniques to reduce substance-related craving. Yet, data obtained on clinical samples remain scarce. Due to the flexibility of the single case design towards each participant, the list of interference-based techniques that will be used in this study cannot be exhaustive. However, the following will be proposed to participants: Tetris (smartphone version), manipulation of a bunch of keys, manipulation of a fidget, mental imagery, reading and memorizing a text. | Behavioural | Problem Gamblers |
Primary outcome
Gambling Craving Strength
Time frame: 6 months
Self-reported Questionnaire: gambling Craving Experience Questionnaire Strength (g-CEQ-S; Cornil et al., in prep) with 9 items rated on a Likert scale from 0 (not at all) to 10 (extremely). It is divided in 3 subscales of 3 items each: intensity, imagery, intrusiveness.
Gambling Craving Frequency
Time frame: 6 months
Self-reported Questionnaire: gambling Craving Experience Questionnaire Frequency (g-CEQ-F; Cornil et al., in prep) with 9 items rated on a Likert scale from 0 (not at all) to 10 (constantly). It is divided in 3 subscales of 3 items each: intensity, imagery, intrusiveness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Background: PubMed 19769435Young MM, Wohl MJ. The Gambling Craving Scale: Psychometric validation and behavioral outcomes. Psychol Addict Behav. 2009 Sep;23(3):512-22. doi: 10.1037/a0015043.
- Background: PubMed 15783293Kavanagh DJ, Andrade J, May J. Imaginary relish and exquisite torture: the elaborated intrusion theory of desire. Psychol Rev. 2005 Apr;112(2):446-67. doi: 10.1037/0033-295X.112.2.446.
- BackgroundCornil, A., Lopez-Fernandez, O., Devos, G., de Timary, P., Goudriaan, A. E., & Billieux, J. (2018). Exploring gambling craving through the elaborated intrusion theory of desire: a mixed methods approach. International Gambling Studies, 18(1), 1-21. https://doi.org/10.1080/14459795.2017.1368686
- Results publication: PubMed 20189549May J, Andrade J, Panabokke N, Kavanagh D. Visuospatial tasks suppress craving for cigarettes. Behav Res Ther. 2010 Jun;48(6):476-85. doi: 10.1016/j.brat.2010.02.001. Epub 2010 Feb 7.
- Results publication: PubMed 22369958Andrade J, Pears S, May J, Kavanagh DJ. Use of a clay modeling task to reduce chocolate craving. Appetite. 2012 Jun;58(3):955-63. doi: 10.1016/j.appet.2012.02.044. Epub 2012 Feb 24.
- Results publication: PubMed 26275843Skorka-Brown J, Andrade J, Whalley B, May J. Playing Tetris decreases drug and other cravings in real world settings. Addict Behav. 2015 Dec;51:165-70. doi: 10.1016/j.addbeh.2015.07.020. Epub 2015 Jul 26.
- Results publicationCornil, A., & Billieux, J. (2017). OP-15. Using interference-based intervention to block gambling craving: A proof of principle study. Journal of Behavioral Addictions, 6 (Suppl.1), 9.
Related trials for Gambling Disorder
RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Gambling Disorder
Recruiting
Digital Cognitive Behavioral Therapy for Gambling Disorder
Gambling Disorder, Gambling
RecruitingObservational study
Is Craving a Central Criterion for Diagnosing a Behavioral Addiction?
Addictive Behaviors, Internet Addiction Disorder
Not yet recruiting
COMpulsive Gambling: Efficacy of DEEP Transcranial Magnetic Stimulation With H7 COIL
Gambling Disorder
Not yet recruiting
QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)
Asperger's Disorder, Asperger Disorder
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.
Olivier Simon contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interference in people with Gambling Disorder and Gambling, Pathological, run by Université Catholique de Louvain at 1 site in Switzerland.
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 5 inclusion and 1 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 28 Jun 2019. 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 Switzerland. 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 Aurélien Cornil (+3210478737, aurelien.cornil@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gambling Craving Strength (time frame: 6 months). The study lists 2 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 NCT03493399, which also lists 7 linked publications.
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 28 Jun 2019.