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临床试验/NCT02306356
NCT02306356已完成不适用

Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年9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
20
试验地点
2
主要终点
Change in Clinical Global Impressions - severity (CGI-S)

研究概览

简要总结

An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting. 20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation anxiety, specific phobia and their parents will be recruited from the CAMHS-center in Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and parent-rated anxiety and functioning.

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
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 8-12 years of age
  • Fulfilling diagnostic criteria for Generalized Anxiety Disorder (GAD), Separation anxiety, Specific phobia
  • Ability to read and write Swedish
  • Daily access to the internet
  • A parent that is able to co-participate in the treatment
  • Participants on psychotropic medication must have been on a stable dose for the last 3 months prior to baseline assessment

排除标准

  • Diagnosed autism spectrum disorder or Attention-deficit/hyperactivity disorder (ADHD), or principal primary disorder other than GAD, Separation anxiety, Specific phobia
  • Acute/severe psychiatric problems such as suicidal risk or severe depression
  • Ongoing psychological treatment for anxiety disorders
  • Ongoing child custody dispute or abuse in the family

结局指标

主要结局

Change in Clinical Global Impressions - severity (CGI-S)

时间窗: baseline, post-treatment (12 weeks), follow-up (3 months)

Change in CGI-s from baseline to post-treatment and follow-up

次要结局

  • Child Sheehan Disability Scale (CSDS)(Baseline, post-treatment (12 weeks), follow-up (3 months))
  • Child Depression Inventory (CDI)(Baseline, post-treatment (12 weeks), follow-up (3 months))
  • Hospital Anxiety Depression Scale (HAD)(Baseline, post-treatment (12 weeks), follow-up (3 months))
  • Client Satisfaction Scale (CSS)(post-treatment (12 weeks))
  • Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)(Baseline, post-treatment (12 weeks), follow-up (3 months))
  • Children´s Global Assessment Scale (CGAS(Baseline, post-treatment (12 weeks), follow-up (3 months))
  • Spence Child Anxiety Scale C/P (SCAS-C/P)(Baseline, post-treatment (12 weeks), follow-up (3 months))
  • Penn State Worry Questionnaire (PSWQ)(Baseline, post-treatment (12 weeks), follow-up (3 months))
  • Separation Anxiety Index (SAI)(Baseline, post-treatment (12 weeks), follow-up (3 months))
  • Fear Survey Schedule for Children - Revised (FSSC-R)(Baseline, post-treatment (12 weeks), follow-up (3 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Serlachius

associate professor

Karolinska Institutet

研究点 (2)

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