Efficacy of an Adaptive, Gamified Digital Therapeutics Intervention for Individuals With Methamphetamine Use Disorder in Community Rehabilitation: A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Change in Cue-Induced Craving Score
研究概览
简要总结
This study evaluates the efficacy of a comprehensive, adaptive digital therapeutics (DTx) smartphone application compared to treatment as usual (TAu) for individuals with Methamphetamine Use Disorder (MUD) receiving community-based rehabilitation. The intervention integrates Internet-based Cognitive Behavioral Therapy (ICBT), adaptive Approach Bias Modification (A-ApBM), cognitive training, and contingency management. The primary hypothesis is that the DTx intervention will result in a greater reduction in cue-induced craving compared to standard community care.
详细描述
Methamphetamine Use Disorder (MUD) lacks effective pharmacotherapies, and traditional psychosocial interventions face scalability challenges in community settings. This pragmatic randomized controlled trial (RCT) aims to assess a smartphone-based digital therapeutic intervention designed to overcome these barriers.
Participants recruited from 12 community rehabilitation centers in Sichuan, China, are randomized 1:1 to either the DTx group or the Treatment as Usual (TAu) group.
The DTx group uses a smartphone application ("WonderLab Harbor+") for 8 weeks as an adjunct to standard care. The app includes:
- Weekly Internet-based CBT sessions.
- Daily Adaptive Approach Bias Modification (A-ApBM) training, which dynamically adjusts difficulty based on performance.
- Gamified cognitive function training.
- A contingency management system rewarding adherence.
The TAu group receives standard counseling services provided by community social workers. The primary outcome is the change in self-reported cue-induced craving from baseline to 8 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years.
- •Currently enrolled in a community rehabilitation program.
- •Ability to fluently operate a smartphone (Android or iOS).
排除标准
- •Presence of a severe mental health condition (e.g., schizophrenia, bipolar I disorder) requiring acute psychiatric care.
- •Inability to provide informed consent.
结局指标
主要结局
Change in Cue-Induced Craving Score
时间窗: Baseline and 8 Weeks (Post-intervention)
Self-reported craving elicited by standardized methamphetamine-related images, measured using a Visual Analog Scale (VAS). Scores range from 0 to 100, with higher scores indicating higher craving. The outcome is defined as the change in score from Baseline to Week 8.
次要结局
未报告次要终点