Virtual Reality Exposure Therapy for Gambling Disorder

Официальное название

Virtual Reality Exposure Therapy for Gambling Disorder: Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое cognitive-behavioral therapy for gambling disorder
  6 sessions of cognitive-behavioral therapy for gambling disorder
• Другое imaginal exposure therapy focus on gambling cues
  6 sessions of imaginal exposure therapy focus on gambling cues
• Другое virtual reality exposure therapy focus on gambling cues
  6 sessions of virtual reality exposure therapy focus on gambling cues

Первичные конечные точки

• Change in South Oaks Gambling Screen (SOGS) between baseline and end of treatment (12 sessions, 6 months) [Срок оценки: at the end of treatment (an average of 6 months)]

Вторичные конечные точки (12)

• Change in South Oaks Gambling Screen (SOGS) between baseline and follow-up at 3, 6 and 12 months after the end of treatment [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: at baseline, and through study completion, an average of 18 months]
• Change in gambling behavior assessed by gambling frequency during the last month [Срок оценки: 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 [Срок оценки: at baseline, and through study completion, an average of 18 months]
• Change in gambling behavior assessed by time spent gambling during the last month [Срок оценки: at baseline, and through study completion, an average of 18 months]
• Change in frequency subscale of gambling Craving Experience Questionnaire (g-CEQ) [Срок оценки: at baseline, and through study completion, an average of 18 months]
• Change in craving reactivity to gambling cues [Срок оценки: at baseline, and through study completion, an average of 18 months]
• Number of craving episodes using daily craving assessed by participants [Срок оценки: up to 6 months during the treatment]
• Cumulative duration of craving episodes using daily craving assessed by participants [Срок оценки: up to 6 months during the treatment]
• Change in gambling-related cognitions assessed by Gambling-Related Cognitions Scale (GRCS) [Срок оценки: at baseline, and through study completion, an average of 18 months]
• Change in depressive symptoms assessed by Beck Depression Inventory short-form (BDI-SF) [Срок оценки: at baseline, and through study completion, an average of 18 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 10 центров

• 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
• … и ещё 2 центра

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗