Virtual Reality Exposure Therapy for Gambling Disorder

Official title

Virtual Reality Exposure Therapy for Gambling Disorder: Randomized Controlled Trial

Overview

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.

Interventions

• 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
• Other virtual reality exposure therapy focus on gambling cues
  6 sessions of virtual reality exposure therapy focus on gambling cues

Primary outcome measures

• 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)]

Secondary outcome measures (12)

• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• Change in frequency subscale of gambling Craving Experience Questionnaire (g-CEQ) [Time frame: 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]
• Number of craving episodes using daily craving assessed by participants [Time frame: 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]
• 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]
• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 10 centers

• CHU Amiens-Picardie — Amiens
• CH Boulogne sur mer CSAPA — Boulogne-sur-Mer
• CHU de Caen — Caen
• Hôpital Fontan, CHU lille — Lille
• Assoriation Cédragir Lomme CSAPA — Lomme
• CH de l'arrondissement de Montreuil / CSAPA — Montreuil-sur-Mer
• CHU Rouen — Rouen
• CH de Saint Amand les Eaux — Saint-Amand-les-Eaux
• … and 2 more centers

Identifiers

NCT: NCT04467502 · 2020_02 · 2020-A02710-39

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗