A Randomized Controlled Trial Protocol Testing the Efficacy of an AI-Based Rehabilitation Treatment in Patients With Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7)
研究概览
简要总结
The trail aimed to test the efficacy of AI-based rehabilitation treatment in patients with anxiety disorders. Specifically, the objective of this trial is to determine whether the AI-based rehabilitation combined with treatment as usual is more effective than treatment as usual alone in improving outcomes in patients with anxiety disorders.
详细描述
This study aims to evaluate an AI-based rehabilitation system for delivering psychological intervention to patients with anxiety disorders. A randomized controlled single-blind trial design was employed to compare the clinical outcomes between patients receiving AI-based rehabilitation treatment combined with standard treatment and those receiving standard treatment alone, in order to evaluate the efficacy of the AI-based rehabilitation system. Additionally, system usability and acceptability will be assessed in the intervention group using standardized scales, evaluating ease of use, task efficiency, interaction quality, and overall user satisfaction, thereby providing evidence to support the clinical integration of AI technology in mental health interventions.
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
- •1. Subjects with anxiety disorders
- •Inclusion Criteria:
- •In accordance with ICD-11 for Anxiety Disorders;
- •Between the ages of 18-60;
- •Completed at least 9 years of education;
- •Ability to use computers or smartphone;
- •Native Chinese speaker;
- •Signing informed consent.
排除标准
- •With severe psychiatric symptoms requiring hospitalization, or unable to complete the required assessment and treatment;
- •Use of cognitive-enhancing medications within the past 6 months;
- •With intellectual, visual, or auditory impairments that affect their ability to interact with aided-diagnostic systems.
研究组 & 干预措施
AI-based rehabilitation treatment combined with standard treatment
Both groups will receive treatment as usual(TAU) provided by the clinical team, including medication, exercise and psychological education. Rehabilitation treatment will be delivered to participants in the testing group through an AI-based intervention system.
干预措施: AI-based rehabilitation treatment combined with standard treatment (Device)
AI-based rehabilitation treatment combined with standard treatment
Both groups will receive treatment as usual(TAU) provided by the clinical team, including medication, exercise and psychological education. Rehabilitation treatment will be delivered to participants in the testing group through an AI-based intervention system.
干预措施: Treatment as Usual (TAU) (Other)
Treatment as usual
Participants in the treatment-as-usual group were offered standard treatment at the mental health hospitals as determined by the clinical team.
干预措施: Treatment as Usual (TAU) (Other)
结局指标
主要结局
Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7)
时间窗: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).
Change in anxiety symptoms, measured by reduction in total score and rate of score reduction on the Generalized Anxiety Disorder 7-item Scale (GAD-7). The GAD-7 total score ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
次要结局
- Change from baseline in depression status, as assessed by the Patient Health Questionnaire-9 (PHQ-9).(Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).)
- Change from baseline in social anxiety symptoms, as measured by the Liebowitz Social Anxiety Scale (LSAS).(Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).)
- Change from baseline in emotion regulation ability, as measured by the Emotion Regulation Questionnaire (ERQ).(Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).)
- Change from baseline in resilience level, as assessed by the Connor-Davidson Resilience Scale-10 (CD-RISC-10).(Change from baseline in resilience level, as assessed by the Connor-Davidson Resilience Scale-10 (CD-RISC-10).)
- Change from baseline in insomnia severity, as assessed by the Insomnia Severity Index (ISI).(Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).)
- Change from baseline in functional impairment, as measured by the Sheehan Disability Scale (SDS).(Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).)
- Patient Global Impression of Improvement(Assessed at immediately post-intervention at week 3 (T1).)
- System usability, as assessed by the Mobile App Usability Questionnaire (MAUQ).(Assessed at immediately post-intervention at week 3 (T1).)