跳至主要内容
临床试验/ISRCTN14296278
ISRCTN14296278进行中(未招募)Unknown

Effectiveness and cost-effectiveness of stepped care guided self-help followed by face-to-face cognitive behavioral therapy versus standalone internet-delivered or face-to-face cognitive behavioral therapy for depression: a randomized controlled non-inferiority trial of the finnish first-line therapies –initiative

Helsinki University Hospital0 个研究点目标入组 948 人开始时间: 2024年9月18日最近更新:
适应症

试验速览

阶段
Unknown
状态
进行中(未招募)
发起方
入组人数
948
主要终点
Within-individual change in depression symptoms measured by the PHQ-9. The PHQ-9 is administered weekly from the beginning of the intervention for 16 weeks and at follow-up time points (e.g. 4, 6, 8, and 12 months as well as 2, 5, 10, 15 and 20 years) to enable ITT (intention to treat) -analysis and modeling the symptom change in time.

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1.Minimum age of 16 years2.Suitable for step 1-2 treatments (guided self-help, iCBT or CBT intervention) for depression in the first assessment3.PHQ-9 =5

排除标准

  • Serious suicidal thoughts, plans or any self-harming act or suicidal attempt within the past 2 months
  • Ongoing other psychological treatment for depression and/or anxiety
  • Cognitive impairment
  • Inability to speak, read and write Finnish
  • Currently symptomatic psychotic illness or bipolar disorder
  • Drug or alcohol dependence

结局指标

主要结局

Within-individual change in depression symptoms measured by the PHQ-9. The PHQ-9 is administered weekly from the beginning of the intervention for 16 weeks and at follow-up time points (e.g. 4, 6, 8, and 12 months as well as 2, 5, 10, 15 and 20 years) to enable ITT (intention to treat) -analysis and modeling the symptom change in time.

次要结局

未报告次要终点

研究者

发起方
Helsinki University Hospital

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