Virtual Reality Exposure Therapy for Gambling Disorder
ConditionGambling Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
cognitive-behavioral therapy for gambling disorder
Other intervention6 sessions of cognitive-behavioral therapy for gambling disorder
imaginal exposure therapy focus on gambling cues
Other intervention6 sessions of imaginal exposure therapy focus on gambling cues
virtual reality exposure therapy focus on gambling cues
Other intervention6 sessions of virtual reality exposure therapy focus on gambling cues
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: CBT with VRETExperimental treatment 2 interventions
Group B: CBT with imaginal ETActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in South Oaks Gambling Screen (SOGS) between baseline and end of treatment (12 sessions, 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.
Time frame
at the end of treatment (an average of 6 months)Secondary outcomes
1
Change in South Oaks Gambling Screen (SOGS) between baseline and follow-up at 3, 6 and 12 months after the end of treatment
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.
Time frame
at baseline, and through study completion, an average of 18 months2
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
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.
Time frame
at baseline, and through study completion, an average of 18 months3
Change in gambling disorder symptoms between baseline, end of treatment and follow-up assessed by the following criteria: Problem Gambling Severity Index (PGSI)
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.
Time frame
at baseline, and through study completion, an average of 18 months4
Change in gambling behavior assessed by gambling frequency during the last month
Time frame
at baseline, and through study completion, an average of 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Ministry of Health, France
Collaborator
Source ClinicalTrials.gov