Effectiveness of Theta Burst Stimulation in the Management of Methamphetamine Use Disorder in Indonesia: A Randomized Controlled Trial as a National Model for Comprehensive Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Improvement in craving for methamphetamine
研究概览
简要总结
Methamphetamine use disorder (MUD) remains a major public health concern in Indonesia, with limited effective treatment options and high relapse rates. Theta Burst Stimulation (TBS) has emerged as a promising adjunctive intervention for reducing craving and improving clinical outcomes. This trial aims to evaluate the efficacy and safety of TBS for MUD. A RCT of 20 subjects was conducted to evalute the efficacy and safety of TBS as an adjunctive treatment to CBT in managing MUD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
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 aged 18-59 years old
- •Subjects diagnosed with methamphetamine use disorder without having undergone treatment, whether psychotherapy and/or psychopharmacological modalities
- •Subjects are able to read and write
排除标准
- •Subjects with severe thought process disorders, impaired perception, restless condition, severe neurological disorders, history of neuromodulation,
- •Subjects refused to participate in the study
- •Subjects who are pregnant
- •Subjects who have radioactive implants
研究组 & 干预措施
TBS and CBT
During 12 days of intervention, the participants underwent 10 sessions of TBS and 12 sessions for CBT.
干预措施: Theta Burst Stimulation (Device)
TBS and CBT
During 12 days of intervention, the participants underwent 10 sessions of TBS and 12 sessions for CBT.
干预措施: Cognitive Behavioral Therapy (Behavioral)
Sham and CBT
During 12 days of intervention, the participants underwent 10 sessions of sham TBS and 12 sessions of CBT.
干预措施: Theta Burst Stimulation (Device)
Sham and CBT
During 12 days of intervention, the participants underwent 10 sessions of sham TBS and 12 sessions of CBT.
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Improvement in craving for methamphetamine
时间窗: Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)
Cue-induced craving was measured with Visual Analog Scale (VAS) where the patient told to indicate their point of craving in a 100 mm line. The scale ranged from 0 to 10, with higher scores indicated higher craving.
Improvement in craving (tonic) for methamphetamine
时间窗: Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)
Tonic or baseline craving was measured using the Questionnaire for Smoking Urges modified for Methamphetamine (QSU-M) in Indonesian version. The questions were self-filled by the participants to identify their level of craving. The QSU-M is a 7-point Likert Scale (1 was strongly disagree and 7 was strongly agree) with the higher total scores indicating higher tonic craving. The total minimum score was 10 while the maximum score was 70.
Improvement in clinical severity
时间窗: Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)
The clinical severity was measured using the Clinical Global Impression - Severity by the psychiatrist based on the patient's condition during the day of examination. CGI is a clinician-rated instrument used to assess the patient's condition based on clinical judgment. CGI mainly rates the severity of illness assessed using a 7-point Likert scale, ranges from 1 (normal) to 7 (among the most extremely ill). Higher score indicated higher severity of addiction-related illness.
次要结局
- Improvement in Addiction Severity(Baseline (T1) and Post-Intervention Day 12 (T6))
- Improvement in Depressive Symptoms(Baseline (T1) and Post-Intervention Day 12 (T6))
- Improvement in Motivation to Change(Baseline (T1) and Post-Intervention Day 12 (T6))
- Improvement in Impulsivity(Baseline (T1) and Post-Intervention Day 12 (T6))
- Improvement in Sleep Quality(Baseline (T1) and Post-Intervention Day 12 (T6))
研究者
Kristiana Siste
Dr. dr. Kristiana Siste, Sp.KJ(K) - Head of Department of Psychiatry, Cipto Mangunkusumo General Hospital
Indonesia University