Clinical trial NCT04467502: Virtual Reality Exposure Therapy for Gambling Disorder
Official title: Virtual Reality Exposure Therapy for Gambling Disorder: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gambling Disorder
Keywords: Exposure therapy
virtual reality
cognitive behavioral therapy
pathological gambling
CBT
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2020-07-13
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in South Oaks Gambling Screen (SOGS) between baseline and end of treatment (12 sessions, 6 months)
timeFrame: at the end of treatment (an average of 6 months)
Secondary outcomes:
measure: Change in South Oaks Gambling Screen (SOGS) between baseline and follow-up at 3, 6 and 12 months after the end of treatment
timeFrame: at baseline, and through study completion, an average of 18 months
measure: 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
timeFrame: at baseline, and through study completion, an average of 18 months
measure: Change in gambling disorder symptoms between baseline, end of treatment and follow-up assessed by the following criteria: Problem Gambling Severity Index (PGSI)
timeFrame: at baseline, and through study completion, an average of 18 months
measure: Change in gambling behavior assessed by gambling frequency during the last month
timeFrame: at baseline, and through study completion, an average of 18 months
measure: Change in gambling behavior assessed by amount of money spent in gambling during the last month
timeFrame: at baseline, and through study completion, an average of 18 months
measure: Change in gambling behavior assessed by time spent gambling during the last month
timeFrame: at baseline, and through study completion, an average of 18 months
measure: Change in frequency subscale of gambling Craving Experience Questionnaire (g-CEQ)
timeFrame: at baseline, and through study completion, an average of 18 months
measure: Change in craving reactivity to gambling cues
timeFrame: at baseline, and through study completion, an average of 18 months
measure: Number of craving episodes using daily craving assessed by participants
timeFrame: up to 6 months during the treatment
measure: Cumulative duration of craving episodes using daily craving assessed by participants
timeFrame: up to 6 months during the treatment
measure: Change in gambling-related cognitions assessed by Gambling-Related Cognitions Scale (GRCS)
timeFrame: at baseline, and through study completion, an average of 18 months
measure: Change in depressive symptoms assessed by Beck Depression Inventory short-form (BDI-SF)
timeFrame: at baseline, and through study completion, an average of 18 months
measure: Change in anxiety symptoms assessed by State-Trait Anxiety Inventory (STAI)
timeFrame: at baseline, and through study completion, an average of 18 months
measure: Rate of patients who attended the 12 sessions (6 months)
timeFrame: up to 6 months during the treatment
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Boulogne-sur-Mer
country: France
facility: CH Boulogne sur mer CSAPA
city: Caen
country: France
facility: CHU de Caen
city: Lille
country: France
facility: Hôpital Fontan, CHU lille
city: Lomme
country: France
facility: Assoriation Cédragir Lomme CSAPA
city: Montreuil sur Mer
country: France
facility: CH de l'arrondissement de Montreuil / CSAPA
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Amand-les-Eaux
country: France
facility: CH de Saint Amand les Eaux
city: Seclin
country: France
facility: CH Seclin Carvin CSAPA
city: Valenciennes
country: France
facility: Association GREID ValenciennesCSAPA
Study officials:
affiliation: University Hospital, Lille
name: Pierre TAQUET, PhD
role: PRINCIPAL_INVESTIGATOR
References: