Feasibility and Acceptability of an Evidence-based Mindfulness Online Resources for Patients With Generalized Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- recruitment rate
研究概览
简要总结
Method: . Forty patients with general anxiety disorder will be randomized in 1:1 ratio to the online resource plus usual care, and to usual care control group by stratified block randomization. Measurements including 7-item Generalized Anxiety Disorder questionnaire, 9-item Patient Health Questionnaire, Penn State Worry questionnaire, and Five Facet Mindfulness Questionnaire will be made at baseline and at 2-month. Rate of recruitment, drop out and website usage will be collected. All patients in the intervention arm will be interviewed to assess the clarity of the app and user experience. The scores between the two arms will be compared by t-test and the transcripts of the patient interviews will be analysed using thematic analysis
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •received a diagnosis of GAD in the computerized record system (CMS) in Hong Kong hospital authority
- •score ≥10 on the 7-item Generalized Anxiety Disorder scale (GAD-7), signifying active moderate anxiety symptoms
- •used any website in prior 12 months
- •received stable dose of psychoactive medications in last 2 months
排除标准
- •any diagnosed psychotic disorder
- •diagnosis of dementia
- •any diagnosed substance abuse disorder (except smoking)
- •active suicidal ideation (score ≥1 on 9-item Patient Health Questionnaire
- •had regular mindfulness meditation practice in last 6 months or had participated in MBSR/MBCT course
结局指标
主要结局
recruitment rate
时间窗: through study completion, an average of 1 year
rate of recruitment during the trial period
dropout rate
时间窗: through study completion, an average of 1 year
rate of dropout during the trial period
次要结局
- Penn State Worry Questionnaire(baseline and 2-month)
- Five Facet Mindfulness Questionnaire(baseline and 2-month)
- 7-item Generalized Anxiety Disorder questionnaire(baseline and 2-month)
- 9-item Patient Health Questionnaire(baseline and 2-month)
研究者
Lee Kam Pui
Clinical Assistant Professor
Chinese University of Hong Kong