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临床试验/NCT02926365
NCT02926365已完成不适用

Increased Access to Psychological Treatment for Children and Adolescents Through Internet-delivered CBT - a Pragmatic Evaluation Within Regular Health Care in a Rural Area of Sweden

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
CGI-S

研究概览

简要总结

The purpose of this study is to test internet-delivered cognitive behavior therapy for children and adolescents with anxiety disorders and obsessive-compulsive disorder in a routine clinical setting in a rural part of Sweden.

详细描述

Aim The aim of this study is to conduct a pragmatic evaluation of ICBT for children and adolescents with anxiety disorders and OCD within routine health care in a rural area.

Research questions

  • Is ICBT an acceptable method for the patient group?
  • Is ICBT effective in a clinical setting?
  • Is further treatment needed after ICBT?
  • What are the long-term effects of ICBT?
  • What predicts treatment outcome?
  • How does ICBT work in a clincal setting? (time spent, negative effects etc)?

Design This is a uncontrolled intervention study where included families and children will be recruited consecutively during two years from a routine care CAMHS unit. All participants will be offered ICBT and assessed pre- and post-treatment, and at three-month follow-up through clinician ratings and self-report measures. The primary outcome measure is clinician rated severity of principal disorder at three-month follow-up. Long-term results will be assessed through study of medical records two years after completed ICBT.

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 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Fulfills diagnostic criteria for an anxiety disorder or OCD
  • Access to a computer and internet connection
  • Read and speak Swedish

排除标准

  • ICBT is currently not assessed to be a suitable treatment
  • Acute psychiatric problem (eg. severe depression or suicidality)
  • Current psychosocial problems in the family (i.e substance abuse, abuse, neglect)

结局指标

主要结局

CGI-S

时间窗: 24 weeks from baseline

Clinical Global Impression - Severity

次要结局

  • Patient satisfaction(12 weeks from baseline)
  • CGI-S(12 weeks from baseline)
  • CGI-I(12 and 24 weeks from baseline)
  • RCADS(12 and 24 weeks from baseline)
  • CY-BOCS(12 and 24 weeks from baseline)
  • CGAS(12 and 24 weeks from baseline)
  • EWSAS(Week 1 through 12 + 24 weeks from baseline)
  • Adverse events(12 weeks from baseline)

研究者

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

Sarah Vigerland

PhD

Karolinska Institutet

研究点 (1)

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