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临床试验/NCT02535403
NCT02535403已完成不适用

Internet-based Cognitive Behavioral Therapy (CBT) for Adolescents With Anxiety Disorders

University of Aarhus2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Change in The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions (ADIS-IV c/p)

研究概览

简要总结

Cognitive behavioral therapy (CBT) is a well-documented and effective method for the treatment of children and adolescents with anxiety disorders. Lately there has been an increase in the development and use of internet-based CBT programs (ICBT), as a means to reduce costs and enhance accessibility of psychological interventions. ICBT has proven efficacious towards adults with anxiety disorders. Research in the field of ICBT with children and adolescents is still in its infancy though and to date, no program targeting anxiety disorders has been developed nor evaluated in Denmark. The primary objective of this study is to investigate the efficacy of a newly developed internet-based treatment program for adolescents with anxiety disorders. The effect will be examined in a randomized controlled trial comparing ICBT to a wait-list control condition.

详细描述

Within the context of a research and teaching clinic at the Department of Psychology and Behavioral Sciences, Aarhus University, Denmark, 70 adolescents aged 13-17 with a primary anxiety disorder as assessed by the ADIS C/P will be randomly allocated to either a 3 month wait-list control condition or a treatment condition.

The treatment consists of an internet-based self-help program for adolescents with anxiety disorders called 'Chilled Out', based on material from the well-established manualised group-treatment Cool Kids Program: Adolescent version. It consists of 8 CBT-inspired modules of approximately 30 minutes each distributed over a 14-week period. The program is interactive using a combination of different media (text, audio, illustrations, cartoons, and videos) to deliver psychoeducation and CBT-inspired techniques, activities and exercises for adolescents to manage their anxiety. In addition, the adolescent will receive a limited amount of therapist support calls.

Participants (youth and parents) are assessed with semi-structured diagnostic interviews and self-report measures before treatment, after 14 weeks (post treatment) and 3 months after treatment (follow-up).

Participants are assessed at pre, post and 3-month follow up.

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
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, social phobia, specific phobia, obsessive compulsive disorder or panic disorder
  • age between 13 and 17 years
  • ability to read and write in Danish
  • direct access to a home computer and internet

排除标准

  • high degree of comorbid depression (CSR above 5 as measured with ADIS-IV)
  • substance abuse
  • current self-harm or suicidal ideation
  • pervasive developmental disorder
  • learning disorder
  • intellectual disability
  • psychotic symptoms
  • All participants are asked not to make changes to their medication status during the course of the trial

结局指标

主要结局

Change in The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions (ADIS-IV c/p)

时间窗: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up

Measures clinician rated anxiety symptoms through Clinician Severity Rating (CSR)

Change in Spence Child Anxiety Scale (SCAS-C/P)

时间窗: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up

Measures self-rated youth anxiety symptoms

次要结局

  • Change in WHO Quality of Life (5 items)(Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up)
  • Change in Children's Anxiety Life Inference Scale (CALIS)(Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up)
  • Change in Self-Efficacy Questionnaire for Children (SEQ-c)(Pre- (baseline) and post- (14 weeks) treatment)
  • Adherence to the program I(Post- (14 weeks) treatment)
  • Experience of Service Questionnaire (ESQ)(Post- (14 weeks) treatment)
  • Adherence to the program IV(Post- (14 weeks) treatment)
  • Parent support(Post- (14 weeks) treatment)
  • Change in the Short version of the Mood and Feelings Questionnaire (S-MFQ-c/p)(Pre- (baseline) and post- (14 weeks) treatment)
  • Adherence to the program III(Post- (14 weeks) treatment)
  • Change in Strength and Difficulties Questionnaire for Youth (SDQ)(Pre- (baseline) and post- (14 weeks) treatment)
  • Change in Working Alliance Inventory - Short form (WAI-S)(Mid- (4 and 8 weeks) and post- (14 weeks) treatment)
  • Adherence to the program II(Post- (14 weeks) treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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