ACTRN12626000908336进行中（未招募）不适用
Evaluating the Cara Plus App: A Randomised Controlled Trial of an Artificial Intelligence Mental Health Intervention (AIMHI) for Adults with Generalised Anxiety and Depression Symptoms.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Educational / counselling / training
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 No limit（—）
- 性别
- All
入选标准
- •Aged 18 years or above.
- •Proficient in English.
- •Residing in Australia or the United States.
- •Access to an Android mobile device with operating system version 8 or higher and reliable internet access.
- •Mild to moderate symptoms of anxiety and/or depression, defined as a GAD-7 score of 5–14 and/or PHQ-9 score of 5–
- •No changes to psychiatric medication in the past four weeks and no planned changes during the 8-week study period.
- •No initiation of structured psychotherapy in the past four weeks and no planned changes to psychotherapy during the 8-week study period.
排除标准
- •Severe anxiety symptoms, defined as a GAD-7 score of 15 or higher
- •Severe depressive symptoms, defined as a PHQ-9 score of 15 or higher
- •Self-reported suicidal ideation, indicated by a PHQ-9 item 9 response greater than 0
- •Self-reported diagnosis of, or symptoms of bipolar disorder or psychotic disorders
- •Self-reported experience of hallucinations, delusions, or loss of contact with reality
- •Self-reported acute mental health crisis requiring urgent or emergency intervention
- •Self-reported current substance dependence
- •Current structured psychotherapy started within past 4 weeks
- •Planned therapy changes during the 8-week intervention window
- •Psychiatric medication changes within the past 4 weeks or planned during the 8-week intervention window
- •Self-reported neurological disorders, including dementia, epilepsy, or intellectual disability
- •Self-reported serious or unstable medical conditions
- •Self-reported use of benzodiazepines
- •Self-reported hearing or vision impairments that would interfere with the app use
- •Current treatment with transcranial magnetic stimulation, electroconvulsive therapy, or ketamine
- •Lack of reliable internet access
- •Prior use of a digital mental health self-help app or structured online self-help programme within the past six months
研究者
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