Virtual Reality Exposure Therapy for Gambling Disorder: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 20
- 主要终点
- Change in South Oaks Gambling Screen (SOGS) between baseline and end of treatment (12 sessions, 6 months)
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
- 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.
- 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.
- Compare the quality of the two therapeutic strategies at the end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CBT with VRET
干预措施: virtual reality exposure therapy focus on gambling cues (Other)
CBT with imaginal ET
干预措施: cognitive-behavioral therapy for gambling disorder (Other)
CBT with imaginal ET
干预措施: imaginal exposure therapy focus on gambling cues (Other)
CBT with VRET
干预措施: cognitive-behavioral therapy for gambling disorder (Other)
结局指标
主要结局
Change in South Oaks Gambling Screen (SOGS) between baseline and end of treatment (12 sessions, 6 months)
时间窗: 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.
次要结局
- Change in gambling disorder symptoms between baseline, end of treatment and follow-up assessed by the following criteria: Problem Gambling Severity Index (PGSI)(at baseline, and through study completion, an average of 18 months)
- Change in gambling behavior assessed by time spent gambling during the last month(at baseline, and through study completion, an average of 18 months)
- Change in frequency subscale of gambling Craving Experience Questionnaire (g-CEQ)(at baseline, and through study completion, an average of 18 months)
- Change in craving reactivity to gambling cues(at baseline, and through study completion, an average of 18 months)
- Number of craving episodes using daily craving assessed by participants(up to 6 months during the treatment)
- Cumulative duration of craving episodes using daily craving assessed by participants(up to 6 months during the treatment)
- Change in gambling-related cognitions assessed by Gambling-Related Cognitions Scale (GRCS)(at baseline, and through study completion, an average of 18 months)
- Change in South Oaks Gambling Screen (SOGS) between baseline and follow-up at 3, 6 and 12 months after the end of treatment(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(at baseline, and through study completion, an average of 18 months)
- Change in gambling behavior assessed by gambling frequency during the last month(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(at baseline, and through study completion, an average of 18 months)
- Change in depressive symptoms assessed by Beck Depression Inventory short-form (BDI-SF)(at baseline, and through study completion, an average of 18 months)
- Change in anxiety symptoms assessed by State-Trait Anxiety Inventory (STAI)(at baseline, and through study completion, an average of 18 months)
- Rate of patients who attended the 12 sessions (6 months)(up to 6 months during the treatment)