Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- GAD7 Response
研究概览
简要总结
Objective: To collect preliminary data and assess the preliminary effectiveness of a game-based digital therapeutics (DTx) intervention for individuals with symptoms of anxiety and depression, and to investigate whether reinforcement learning (RL) can personalize the intervention and enhance effectiveness. Design: Randomized controlled trial with three arms. Setting: Internet-based recruitment and delivery of the intervention. Participants: 223 individuals with symptoms of anxiety and depression, aged between 18 and 50 years. Interventions: Participants were randomly assigned to one of three groups: game-based DTx with RL algorithm (RL algorithm group), game-based DTx without RL algorithm (no algorithm group), and a blank control group. Main Outcomes and Measures: The primary outcomes were reductions in symptoms of anxiety and depression, measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scales. Response rates and rates of recovery, as well as the impact of demographic variables, were also examined.
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 (Participant)
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;
- •having a PHQ-9 score or a GAD-7 score upon enrollment;
- •being able to operate a smartphone fluently;
- •having normal vision after correction
排除标准
- •clinical diagnoses of severe psychiatric conditions such as schizophrenia or bipolar disorder;
- •at high risk of suicide or self-harm;
- •having significant cognitive impairments;
- •active substance abuse or dependence;
- •currently undergoing other psychological or pharmacological treatments for depression or anxiety;
- •pregnant individuals or those with postpartum depression, and those with serious physical health conditions that could impact mental health.
结局指标
主要结局
GAD7 Response
时间窗: Immeidately after intervention
A user is said to responded to the intervention if the PHQ9 score dropped no less than 50% compared to the baseline
PHQ9 Response
时间窗: Immeidately after intervention
A user is said to responded to the intervention if the PHQ9 score dropped no less than 50% compared to the baseline
次要结局
未报告次要终点