Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Revised Child Anxiety and Depression Scale -47 - Self-report
研究概览
简要总结
The goal of this feasibility and pilot study is to investigate the feasibility and preliminary clinical effects of a new rule-based chatbot intervention for adolescents with anxiety symptoms. The main questions are:
- Is the intervention feasible for adolescents who are experiencing anxiety symptoms?
- How do the adolescents experience the use of the intervention?
- Does the intervention lead to a reduction in anxiety symptoms?
- Does the intervention lead to a clinically significant reliable improvement at functional level?
详细描述
Anxiety is one of the most common psychiatric disorders and the anxiety symptoms typically onsets in adolescence. The anxiety symptoms may be persistent into adulthood, leading to a poorer life quality and function impairments. The goal is to prevent the development of anxiety and comorbid disorders, as well as function impairment due to anxiety symptoms. This study wishes to investigate the feasibility and preliminary clinical effects of a digital intervention in an open pre-post and 3 months follow up study. The intervention consists of a rule-based click-chatbot, combined with therapist-guidance. This study will recruit N = 30 adolescents from Norway from age 13 up to 16 years old to investigate the feasibility and preliminary clinical effects of a rule-based click chatbot-intervention, and whether it causes a reduction in anxiety symptoms and increases of life functioning. If the intervention is feasible with promising results, the study will serve as a first step to a future randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •reporting anxiety symptoms that hinders them in participating in daily activities
- •spending time trying to avoid these anxiety symptoms
- •aged 13 and up to 16 years
- •can read Norwegian
排除标准
- •clinical cut-off on OCD subscale on RCADS-47> 10,
- •clinical cut-off on Depression subscale on RCADS-47 > 16,
- •ongoing treatment
- •extensive reading/writing difficulties
- •extensive concentration problems
结局指标
主要结局
Revised Child Anxiety and Depression Scale -47 - Self-report
时间窗: assessing change from screening, pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months
anxiety and depressive symptoms, higher score indicates worse outcomes
Revised Child Anxiety and Depression Scale - 25 - Self-report
时间窗: assessing change from week 2, and week 4
short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms
Revised Child Anxiety and Depression Scale - 25 - Parent version
时间窗: assessing change from week 2, and week 4
parent-reported, short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms
Revised Child Anxiety and Depression Scale -47 - Parent version
时间窗: assessing change from pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months
parent-reported anxiety and depressive symptoms, higher score indicates worse outcomes
次要结局
- Strengths and Difficulties Questionnaire - Youth version(assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months)
- Strengths and Difficulties Questionnaire - Parent version(assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months)