Virtual Reality Exposure Therapy for Gambling Disorder (VIRET-GAD)

May 11, 2026 updated by: University Hospital, Lille

Virtual Reality Exposure Therapy for Gambling Disorder: Randomized Controlled Trial

Gambling disorder (GD) is recognized as an addictive disorder in the DSM-5. Craving is a core phenomenon in addiction that can lead to relapse in problem gambling for pathological gamblers. Exposure Therapy (ET) focuses on craving in addiction treatment. ET in Cognitive-Behavioral Therapy (CBT) is based on classical conditioning that addresses the association between contextual cues and the craving response. ET helps the patient to reduce craving when faced with cues triggering craving. ET includes in vivo exposure and imaginal exposure. The literature recommends being as close as possible to the context of addiction to facilitate the extinction of craving but in vivo ET is complicated to perform. For GD, in outpatient consultation, bringing a patient to a casino presents obstacles (e.g., time, human and financial cost, agreement with casino for therapy).

The study will be to assess the effectiveness of Virtual Reality Exposure Therapy (VRET) in a virtual gambling environment. Various trials show that VRET is no more or less effective than classical ET in CBT but has other advantages for motivation to treatment. This research aims to compare efficacy between CBT with VRET and CBT with imaginal exposure for treatment of GD in a multicenter, randomized, controlled, non-inferiority clinical trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Main aim:

Show, within patients seeking care for GD, that VRET integrated with CBT is non-inferior to imaginal ET integrated with CBT on GD symptom reduction at the end of 12 treatment sessions.

Secondary objectives:

  1. Show that VRET integrated with CBT is non-inferior to imaginal ET integrated with CBT on GD symptom reduction during the first 12 months post-treatment.
  2. Compare the effect of the two therapeutic strategies on GD symptoms (measured by complementary assessments to that used in the main aim), at the end of treatment and during the first 12 months post-treatment.
  3. Show the efficacy of VRET integrated with CBT compared to imaginal ET integrated with CBT on gambling behavior, craving, and gambling-related cognitions at the end of treatment and during the first 12 months post-treatment.
  4. Show the efficacy of VRET integrated with CBT compared to imaginal ET integrated with CBT on the evolution of anxiety and depressive symptoms at the end of treatment and during the first 12 months post-treatment.
  5. Compare the quality of the two therapeutic strategies at the end of treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • CHU Amiens-Picardie
        • Principal Investigator:
          • Alain DERVAUX, MD,PhD
      • Boulogne-sur-Mer, France
        • Not yet recruiting
        • CH Boulogne sur mer CSAPA
        • Principal Investigator:
          • Fréderic TEISSIERE, MD
      • Caen, France
        • Not yet recruiting
        • CHU de Caen
        • Principal Investigator:
          • Nicolas CABE, MD
      • Lille, France, 59000
        • Not yet recruiting
        • Hôpital Fontan, CHU lille
        • Principal Investigator:
          • Olivier COTTENCIN, MD,PhD
      • Lomme, France
        • Not yet recruiting
        • Assoriation Cédragir Lomme CSAPA
        • Sub-Investigator:
          • Stéphanie Lienard
      • Montreuil-sur-Mer, France
        • Not yet recruiting
        • CH de l'arrondissement de Montreuil / CSAPA
        • Sub-Investigator:
          • Mathieu LAWNICZAK
      • Rouen, France
        • Not yet recruiting
        • CHU Rouen
        • Principal Investigator:
          • Olivier GUILLIN, MD, PhD
      • Saint-Amand-les-Eaux, France
        • Not yet recruiting
        • CH de Saint Amand les Eaux
        • Principal Investigator:
          • Charles LESCUT, MD
      • Seclin, France
        • Recruiting
        • CH Seclin Carvin CSAPA
        • Principal Investigator:
          • Pierre TAQUET, PhD
      • Valenciennes, France
        • Not yet recruiting
        • Association GREID ValenciennesCSAPA
        • Sub-Investigator:
          • Ines Roux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Seek treatment for GD within one of health care facilities participating in the research (first request for treatment and not patients already receiving treatment for gambling disorder in the care center).
  • Meet a current diagnosis of gambling disorder according to DSM-5 criteria and with a South Oaks Gambling Screen (SOGS) score ≥ 5
  • Meet a casino gambling behavior with a casino gambling frequency ≥ 1 time every two months during the last 12 months
  • Have a sufficient understanding of French for therapy
  • Beneficiary of the French social security system
  • Give an informed consent to participate
  • Willing to comply with all study procedures and duration

Exclusion Criteria:

  • Visual disturbance making impossible the use of virtual reality equipment (e.g. advanced retinal degeneration, central scotoma, age-related macular degeneration)
  • Pregnant woman
  • Minor or adult under guardianship, conservatorship, under judicial protection, persons deprived of their liberty
  • Balance disorder (e.g. cerebellar disorder, inner ear disorder)
  • Photosensitive epilepsy
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CBT with VRET
Other: cognitive-behavioral therapy for gambling disorder
6 sessions of cognitive-behavioral therapy for gambling disorder
Other: virtual reality exposure therapy focus on gambling cues
6 sessions of virtual reality exposure therapy focus on gambling cues
Active Comparator: CBT with imaginal ET
Other: cognitive-behavioral therapy for gambling disorder
6 sessions of cognitive-behavioral therapy for gambling disorder
Other: imaginal exposure therapy focus on gambling cues
6 sessions of imaginal exposure therapy focus on gambling cues

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in South Oaks Gambling Screen (SOGS) between baseline and end of treatment (12 sessions, 6 months)
Time Frame: at the end of treatment (an average of 6 months)
The SOGS is a 20-item instrument used to screen for pathological gambling. The SOGS is scored by summing the number of items endorsed out of 20 and a cut score of 5 or more indicates a probable pathological gambling. The score ranges from 0 to 20.
at the end of treatment (an average of 6 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in South Oaks Gambling Screen (SOGS) between baseline and follow-up at 3, 6 and 12 months after the end of treatment
Time Frame: at baseline, and through study completion, an average of 18 months
The SOGS is a 20-item instrument used to screen for pathological gambling. The SOGS is scored by summing the number of items endorsed out of 20 and a cut score of 5 or more indicates a probable pathological gambling. The score ranges from 0 to 20.
at baseline, and through study completion, an average of 18 months
Change in gambling disorder symptoms between baseline, end of treatment and follow-up assessed by the following criteria: number of DSM-5 criteria for GD
Time Frame: at baseline, and through study completion, an average of 18 months
Nine criteria for gambling disorder are described in DSM-5. The endorsement of 4-5 criteria means the presence of a mild gambling disorder, 6-7 criteria a moderate gambling disorder and 8-9 criteria a severe gambling disorder. The score ranges from 0 to 9 criteria.
at baseline, and through study completion, an average of 18 months
Change in gambling disorder symptoms between baseline, end of treatment and follow-up assessed by the following criteria: Problem Gambling Severity Index (PGSI)
Time Frame: at baseline, and through study completion, an average of 18 months
The PGSI consists of nine items to assess level of risk for problem gambling. Cut-off scores are 1-2 for low-risk gamblers, 3-7 for moderate-risk gamblers and 8 or more for problem-gamblers. Non-problem gamblers correspond to 0. The score ranges from 0 to 27.
at baseline, and through study completion, an average of 18 months
Change in gambling behavior assessed by gambling frequency during the last month
Time Frame: at baseline, and through study completion, an average of 18 months
at baseline, and through study completion, an average of 18 months
Change in gambling behavior assessed by amount of money spent in gambling during the last month
Time Frame: at baseline, and through study completion, an average of 18 months
at baseline, and through study completion, an average of 18 months
Change in gambling behavior assessed by time spent gambling during the last month
Time Frame: at baseline, and through study completion, an average of 18 months
at baseline, and through study completion, an average of 18 months
Change in frequency subscale of gambling Craving Experience Questionnaire (g-CEQ)
Time Frame: at baseline, and through study completion, an average of 18 months
The frequency subscale of gambling Craving Experience Questionnaire assesses the frequency of craving for gambling during the last week. This questionnaire consists of nine items. A high score means a high frequency of craving during the last week. The score ranges from 0 to 90.
at baseline, and through study completion, an average of 18 months
Change in craving reactivity to gambling cues
Time Frame: at baseline, and through study completion, an average of 18 months
at baseline, and through study completion, an average of 18 months
Number of craving episodes using daily craving assessed by participants
Time Frame: up to 6 months during the treatment
up to 6 months during the treatment
Cumulative duration of craving episodes using daily craving assessed by participants
Time Frame: up to 6 months during the treatment
up to 6 months during the treatment
Change in gambling-related cognitions assessed by Gambling-Related Cognitions Scale (GRCS)
Time Frame: at baseline, and through study completion, an average of 18 months
The French version of the Gambling-Related Cognitions Scale consists of 23 items to assess various cognitions related to gambling. A high score means that gambling-related cognitions are typical cognitions of problem gamblers. The score ranges from 23 to 161.
at baseline, and through study completion, an average of 18 months
Change in depressive symptoms assessed by Beck Depression Inventory short-form (BDI-SF)
Time Frame: at baseline, and through study completion, an average of 18 months
Beck Depression Inventory short-form consists of 13 items to assess depressive symptoms. A high score means a high level of depressive symptoms. The score ranges from 0 to 39.
at baseline, and through study completion, an average of 18 months
Change in anxiety symptoms assessed by State-Trait Anxiety Inventory (STAI)
Time Frame: at baseline, and through study completion, an average of 18 months
State-Trait Anxiety Inventory consists of 20 items to assess state-anxiety and 20 items to assess trait-anxiety. A high score means a high level of anxiety symptoms. The score ranges from 20 to 80 both for state-anxiety and trait-anxiety.
at baseline, and through study completion, an average of 18 months
Rate of patients who attended the 12 sessions (6 months)
Time Frame: up to 6 months during the treatment
Quality of the two therapeutic strategies
up to 6 months during the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre TAQUET, PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020_02
  • 2020-A02710-39 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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