Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in The Treatment of Gambling Disorder in Indonesia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement in pathological gambling score
研究概览
简要总结
Research has shown that cognitive-behavioral therapy (CBT) is an effective treatment for gambling disorder. Several studies had also been done to evaluate the effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in addiction management, particularly in alleviating craving. A randomised controlled trial (RCT) of 60 subjects would be conducted to evaluate the effectiveness of transmodalistic therapy with a combination of rTMS and CBT for online gambling disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with pathological gambling (SOGS score ≥ 5)
- •Subjects aged 18-70 years old
- •Subjects who understand Bahasa Indonesia
- •Subjects who agree to participate and receive treatment
排除标准
- •Subjects with history of psychotic disorder, personality disorder, or sleep disorder according to ICD-11
- •Subjects with history of neurostimulation
- •Subjects with history of medical implant
- •Subjects with history of severe neurological disorder, which causes seizure or loss of consciousness
- •Subjects with intellectual disability
- •Subjects with endocrinological disorders
- •Subjects with contraindication during prior MR or other related procedures
- •Subjects who are currently or expecting pregnancy
- •Subjects with history of substance use in the last 6 months
结局指标
主要结局
Improvement in pathological gambling score
时间窗: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
South Oaks Gambling Screen (SOGS), Indonesian version, with minimum score of 0 and maximum score of 20. A score of 0-2 indicates no pathological gambling; a score of 3-4 indicates problems with gambling, and a score of 5 or more indicates that the subject is a probable pathological gambler. Lower score indicates a better outcome.
Improvement in gambling symptoms severity
时间窗: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
Gambling Symptoms Assessment Scale (G-SAS), Indonesian version, with minimum score of 0 and maximum score of 48. Interpretations: Mild (8-20), Moderate (21-30), Severe (31-40), and Extreme (41-48). Lower score indicates a better outcome.
Improvement in gambling urge
时间窗: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
Gambling Urge Scale (GUS), Indonesian version, with minimum score of 0 and maximum score of 42. Lower score indicates a better outcome.
Improvement in gambling related cognitive distortions
时间窗: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
Gambling Related Cognitions Scale (GRCS), Indonesian version, with 5 cognitive distortion domains. Lower score indicates a better outcome.
次要结局
- Improvement in gambling-related cognitive functions(Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention)
- Improvement in depression symptoms(Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention)
- Improvement in self-reported psychological distress(Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention)
- Improvement of overall severity of illness(Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention)
研究者
Kristiana Siste
Dr. dr. Kristiana Siste, SpKJ(K) - Head of Department of Psychiatry, Faculty of Medicine, Indonesia University
Indonesia University