Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Behavioral Therapy (CBT) in the Management of Gambling Disorder in Indonesia: a Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Improvement in pathological gambling score
研究概览
简要总结
Treatment options for gambling disorder (GD) remain limited, with no pharmacotherapy proven effective. As of date, cognitive behavioral therapy (CBT) is the preferred therapy for GD, but the improvements often require months to show, highlighting the need for a more comprehensive therapy. Repetitive transcranial magnetic stimulation (rTMS) is a promising treatment modality in alleviating craving. Studies have shown potential benefit of combining both CBT and rTMS in substance addiction, but not in GD. Thus, this study aims to determine the feasibility and efficacy of rTMS and CBT combination therapy in the management of GD in Indonesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（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 and personality disorder according to ICD-11
- •Subjects with severe neurological disorder comorbidities, which cause seizure or loss of consciousness
- •Subjects with intellectual disability
- •Subjects with history of neurostimulation
- •Subjects with history of medical implant
- •Subjects currently or expecting pregnancy
- •Subjects fulfilling diagnostic criteria of substance use disorder 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