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临床试验/NCT06531980
NCT06531980招募中不适用

Effektiviteten av en Digital Mestringsapp for Ungdommer Med Mild Til Moderat Angst

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
128
试验地点
2
主要终点
Revised Child Anxiety and Depression Scale - 25 - Parent-report

研究概览

简要总结

The goal of this randomized controlled trial is to investigate the effectiveness of a new therapist-guided rule based intervention in Bergen Municipality, Child and Family help center.

Do they have a decrease in anxiety symptoms following the intervention? Do they have an increase in functional level following the intervention?

Researchers will compare the therapist-guided rule based intervention with treatment as usual for adolescents with mild to moderate anxiety.

Participants will use the intervention, which is based on CBT, for 8 weeks.

详细描述

Modi is a mobile application and consists of a training program for adolescents with anxiety problems. Anxiety is one of the most common mental disorders. The anxiety symptoms usually have an age of onset in adolescence. For many, these anxiety symptoms persist into adulthood, and lead to reduced quality of life and functional impairment. The goal is to prevent anxiety disorders, comorbid disorders and loss of function as a result of the anxiety symptoms.

This study wants to investigate the effectiveness of a digital intervention in a randomized controlled trial. The study will recruit N = 128 young people aged 13-16 who will be randomized to either a therapist-guided, rule-based chatbot intervention or treatment as usual in the Child and Family Help Center in Bergen Municipality. The study will examine the clinical effects of the new intervention compared to treatment as usual

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 (Investigator)

盲法说明

A member of the research group will conduct the randomization

入排标准

年龄范围
13 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 13-16
  • Resides in Bergen
  • Completed RCADS-25
  • Reports "yes" to both questions:
  • Do you have anxiety symptoms? Do you often feel stressed, scared, worried, or feel it in your body (e.g., stomach pain, heart palpitations, breathing problems, sweating, dizziness)?
  • Do anxiety symptoms prevent you from doing things you want or need to do (e.g., meeting new people, giving presentations at school, going to sleepovers, going to the shopping center)? Or do you spend so much time worrying that it affects your daily life? Can read Norwegian

排除标准

  • Currently receiving other psychological treatment
  • Immediate need for other psychological treatment, such as severe depression, suicide risk, OCD, psychosis/substance abuse issues, autism spectrum disorder
  • Anxiety is largely related to bullying
  • Extensive school absence of more than 50% in the last three months

结局指标

主要结局

Revised Child Anxiety and Depression Scale - 25 - Parent-report

时间窗: assessing change from screening, pre, week 2, week 4, week 6, and immediately after the intervention, follow-up 1 month, and at follow-up 6 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 screening, pre, week 2, week 4, week 6, and immediately after the intervention, follow-up 1 month, and at follow-up 6 months]

anxiety and depressive symptoms, higher score indicates worse outcomes

次要结局

  • Strengths and Difficulties Questionnaire - Parent version(assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months])
  • Strengths and Difficulties Questionnaire - Youth version(assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months])

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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