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Testing Interference-based Methods to Mitigate Gambling Craving - A Multiple Single Case Design

Primary Purpose

Gambling Disorder, Gambling, Pathological, Craving

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Interference
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gambling Disorder focused on measuring Gambling, Craving, Urge, Desire, Interference, Elaborated Intrusion Theory, Treatment, Intervention, Clinical Sample, Single case

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Outpatients from CJE
  • In therapy for a Gambling Disorder
  • French speaking
  • Signifiant gambling cravings (clinically assessed)
  • Sign an inform consent

Exclusion Criteria:

  • Comorbidities (psychosis, acute manic phase, acute depressive phase, suicidal phase, mental retardation, alcohol intoxication or other psychic state incompatible with the study)

Sites / Locations

  • Centre du Jeu Excessif

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Problem Gamblers

Arm Description

Interference

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2018
Last Updated
June 27, 2019
Sponsor
Université Catholique de Louvain
Collaborators
University of Luxembourg, Centre Hospitalier Universitaire Vaudois, University of Geneva, Switzerland, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03493399
Brief Title
Testing Interference-based Methods to Mitigate Gambling Craving - A Multiple Single Case Design
Official Title
Testing Interference-based Methods to Mitigate Gambling Craving - A Multiple Single Case Design
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
October 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain
Collaborators
University of Luxembourg, Centre Hospitalier Universitaire Vaudois, University of Geneva, Switzerland, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder, Gambling, Pathological, Craving, Gambling, Gambling Problem
Keywords
Gambling, Craving, Urge, Desire, Interference, Elaborated Intrusion Theory, Treatment, Intervention, Clinical Sample, Single case

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Problem Gamblers
Arm Type
Experimental
Arm Description
Interference
Intervention Type
Behavioral
Intervention Name(s)
Interference
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gambling Craving Strength
Description
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.
Time Frame
6 months
Title
Gambling Craving Frequency
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients from CJE In therapy for a Gambling Disorder French speaking Signifiant gambling cravings (clinically assessed) Sign an inform consent Exclusion Criteria: Comorbidities (psychosis, acute manic phase, acute depressive phase, suicidal phase, mental retardation, alcohol intoxication or other psychic state incompatible with the study)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélien Cornil
Phone
+3210478737
Email
aurelien.cornil@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Simon
Email
olivier.simon@chuv.ch
Facility Information:
Facility Name
Centre du Jeu Excessif
City
Lausanne
State/Province
Vaud
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Simon
Email
olivier.simon@chuv.ch

12. IPD Sharing Statement

Citations:
PubMed Identifier
19769435
Citation
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. Erratum In: Psychol Addict Behav. 2009 Dec;23(4):563.
Results Reference
background
PubMed Identifier
15783293
Citation
Kavanagh 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.
Results Reference
background
Citation
Cornil, 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 Reference
background
PubMed Identifier
20189549
Citation
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.
Results Reference
result
PubMed Identifier
22369958
Citation
Andrade 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 Reference
result
PubMed Identifier
26275843
Citation
Skorka-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 Reference
result
Citation
Cornil, 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.
Results Reference
result

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Testing Interference-based Methods to Mitigate Gambling Craving - A Multiple Single Case Design

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