The effectiveness of a cognitive behavioral treatment with virtual reality for problem gambling

ISRCTN ISRCTN16969130
DOI https://doi.org/10.1186/ISRCTN16969130
Secondary identifying numbers FRQSC (Funding): 2020-0JUR-293539 and UQO Ethic committee no: 2022-1121
Submission date
27/06/2022
Registration date
19/07/2022
Last edited
11/03/2024
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Pathological gambling is characterized by a loss of control over gambling, deception about the extent of one’s involvement with gambling, family and job disruption, theft, and chasing losses, or the effort to win back money lost while gambling. About 1% of the adult population is said to be a pathological gambler.
Cognitive-behavioral treatment of gambling-related disorder, although effective, is associated with a high dropout rate. Some players consider that it does not answer adequately to their needs. Few alternatives have been rigorously evaluated, but the exposure treatments offer beneficial clinical opportunities while demonstrating, in some studies, comparable efficacy to cognitive processing.
This research aims to assess whether a behavioral treatment with virtual reality exposure would increase the feeling of self-efficacy of people with an addiction to video lottery machines not to play despite the presence of a desire to play in order to ultimately reduce their gambling behavior.

Who can participate?
Persons over 18 years of age who have a diagnosed pathological gambling problem, and speak French.

What does the study involve?
Interested individuals will have to participate in an initial selection interview. Then, individuals will be invited to participate in a face-to-face diagnostic evaluation interview on pathological gambling at the Université du Québec en Outaouais (UQO). Participants (7 participants) will be randomly assigned to baselines of different lengths before the treatment begins. The study follows the design for single-case studies with multiple baselines across subjects. The effectiveness of the treatment will also be assessed at a 6-month follow-up.

What are the possible benefits and risks of participating?
The potential benefit is to receive a free treatment for pathological gambling which is likely to lead to clinical improvements. The potential risks are the psychological discomfort associated with being in psychotherapy (e.g., engaging in personal and emotionally challenging issues) and cybersickness (unwanted negative side effects of immersion in virtual reality, such as nausea or dizziness).

Where is the study run from?
Université du Québec en Outaouais (Canada)

When is the study starting and how long is it expected to run for?
December 2019 to September 2025

Who is funding the study?
Fonds de Recherche du Québec-Société et Culture (Canada)

Who is the main contact?
Professor Stephane Bouchard, stephane.bouchard@uqo.ca

Contact information

Prof Stéphane Bouchard
Principal Investigator

UQO - Dept. psychologie
C.P.1250 Succ Hull
Gatineau
J8X3X7
Canada

ORCiD logoORCID ID 0000-0002-5995-340X
Phone +18195953900, ext. 2360
Email stephane.bouchard@uqo.ca

Study information

Study designSingle-case studies
Primary study designInterventional
Secondary study designSingle-case studies
Study setting(s)Other
Study typeTreatment
Participant information sheet http://w3.uqo.ca/cyberpsy/
Scientific titlePathological gambling: effectiveness of a cognitive behavioral treatment with virtual reality based exposure
Study acronymJeuPathoTCC-RV
Study objectivesIt is expected that the treatment will lead to a reduction in gambling behaviors, in the number of cases meeting the diagnosis of pathological gambling, in the desire to gamble, in cognitive distortions, as well as an increase in the perception of self-efficacy compared to the waiting group. Finally, these therapeutic gains are expected to be maintained at 6 and 12 month follow-ups.
Ethics approval(s)Approved 10/01/2022, Comité d’Éthique à la Recherche de l’Université du Québec en Outaouais (Pavillon Alexandre-Taché, bureau F-2013, Quebec, Canada; +1 819 595-3900; comite.ethique@uqo.ca), ref: 2022-1121
Health condition(s) or problem(s) studiedTreatment and relapse prevention for adults suffering from pathological gambling
InterventionAfter receiving an appropriate diagnosis and completing the ethics procedures, participants will be randomly assigned to one of the following two conditions:
1. Experimental condition: Cognitive Behavioral Treatment with Virtual Reality Based Exposure (6 sessions):
1.1 Session 1: psychoeducation about pathological gambling, introduction to the cognitive behavioral approach and virtual reality.
1.2 Session 2-4: application of cognitive behavioral strategies with exposure (imaginal and in virtuo exposure).
1.3 Session 5-6: Exposure and relapse prevention.

2. Control condition: Waiting list

Follow up at 6 and 12 months

Randomization
Prior to the start of the study, randomization is done with an app that generates random numbers between 0 and 1 corresponding to the Control or Experimental condition. A table is then created and handled by the research coordinator. The rest of the research team and the psychotherapist do not have access to this list. The moment they are accepted in the study, participants are automatically assigned to the next available slot in the table.
Intervention typeBehavioural
Primary outcome measureCurrent primary outcome measure as of 11/03/2024:
Gambling Self Efficacy Questionnaire completed on a daily basis during the baseline and treatment phases.

Previous primary outcome measure:
Gambling Self Efficacy Questionnaire (GSEQ; May, Whelan Steenbergh & Meyers, 2003) at pre- and post-test as well as at 6- and 12-month follow-ups.
Secondary outcome measures1. Entrevue diagnostique sur le jeu pathologique-5 (EDJP-5): diagnostic interview at pre- and post-test as well as at 6- and 12-months follow-ups.
2. Gambling Craving Scale (GACS; Young & Wohl, 2009): at pre- and pos-test as well as at 6- and 12-months follow-ups.
3. Information Biases Scale (IBS; Jefferson & Nicki, 2003): at pre- and pos-test as well as at 6- and 12-months follow-ups.
4. Experience lived during the exposure measured using Questionnaire d’attentes envers l’exposition (QAE; Bergeron, Giroux et Bouchard, 2019): before and after each exposure.
5. Cybersickness symptoms measured using Simulator Sickness Questionnaire (QC; Kennedy, Lane, Berbaum, & Lilienthal, 1993; Bouchard et al., 2011): before and after each exposure in virtual reality.
Overall study start date06/12/2019
Completion date30/09/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants7
Key inclusion criteria1. French speaking
2. At least 18 years old
3. Receiving a principal diagnosis of Pathological gambling based on DSM-5 diagnostic criteria. Assessed with a semi-structured diagnostic interview (EDJP-5)
4. Mainly play VLT
5. Having a goal of abstinence from gambling
6. Do not suffer from health problems that may be exacerbated by the VR treatment (e.g., intense and frequent discomfort during car trips, vestibular or inner ear disorders, recurrent migraines, epilepsy, partial or total blindness).
7. Do not suffer from a untreated mental health problem that may be contraindicated in VR (e.g., psychotic disorders, intellectual disability, bipolar affective illness).
8. Being able to travel to the Université du Québec en Outaouais
Key exclusion criteria1. Do not speak French
2. Less than 18 years old
3. Do not have received a principal diagnosis of Pathological gambling based on DSM-5 diagnostic criteria. Assessed with a semi-structured diagnostic interview (EDJP-5)
4. Do not mainly play VLT
5. Do not have a goal of abstinence from gambling
6. Suffer from health problems that may be exacerbated by the VR treatment (e.g., intense and frequent discomfort during car trips, vestibular or inner ear disorders, recurrent migraines, epilepsy, partial or total blindness).
7. Suffer from a untreated mental health problem that may be contraindicated in VR (e.g., psychotic disorders, intellectual disability, bipolar affective illness).
8. Do not be able to travel to the Université du Québec en Outaouais
Date of first enrolment01/09/2022
Date of final enrolment31/03/2024

Locations

Countries of recruitment

  • Canada

Study participating centres

University of Quebec at Outaouais (Université du Québec en Outaouais (UQO))
Department of Psychology (Dept. psychologie)
C.P.1250 succ. Hull
Gatineau
J8X3X7
Canada
Laval University - School of Psychology (Université Laval - École de psychologie)
Pavillon Félix-Antoine-Savard
2325 rue des Bibliothèques
Québec
G1V0A6
Canada

Sponsor information

Fonds de Recherche du Québec - Société et culture
Government

FRQSC
140 Grande Allée Est
bureau 470
Québec
G1R5M8
Canada

Phone +1 (418) 643-7582
Email frq.sc@frq.gouv.qc.ca
Website http://www.frqsc.gouv.qc.ca
ROR logo "ROR" https://ror.org/00shpc021

Funders

Funder type

Government

Fonds de Recherche du Québec-Société et Culture
Government organisation / Local government
Alternative name(s)
Quebec Research Fund-Society and Culture, Le FRQSC, The FRQSC, Le Fonds de recherche du Québec, FRQSC, FRQ
Location
Canada

Results and Publications

Intention to publish date30/11/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
stephane.bouchard@uqo.ca

Editorial Notes

11/03/2024: The following changes were made to the study record:
1. The study design was changed from 'Interventional randomized controlled trial' to 'Single-case studies'.
2. The overall study end date was changed from 30/09/2024 to 30/09/2025.
3. The primary outcome measure was updated.
4. The target number of participants was changed from 40 to 7.
5. The intention to publish date was changed from 30/11/2025 to 30/11/2026.
14/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2023 to 31/03/2024.
2. The overall trial end date was changed from 31/03/2024 to 30/09/2024.
05/07/2022: Trial's existence confirmed by l’Université du Québec en Outaouais.