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临床试验/NCT02178631
NCT02178631已完成不适用

Effectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression

University of Luebeck4 个研究点 分布在 2 个国家目标入组 163 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
163
试验地点
4
主要终点
Patient Health Questionnaire - 9 items (PHQ-9)

研究概览

简要总结

Online self-help is an innovative way of providing self-help. The investigators want to study the effect of an interactive online self-help-program (Deprexis) in the treatment of severe depressive symptoms. Participants will be randomised to either twelve weeks of online-self help or a waiting-list control. Symptoms of depression and other aspects will be assessed over a six months period. The investigators hypothesise that online self-help is superior to the control condition in alleviating depressive symptoms and preventing full blown depression.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 65, ability to read German, willingness to participate in a telephone diagnostic interview, achieving a score of at least 15 on the PHQ-9 in an initial screening, and providing written informed consent

排除标准

  • Lifetime diagnosis of schizophrenia or bipolar disorder (as determined by a telephone diagnostic interview) or current suicidality (as determined in a telephone interview)

结局指标

主要结局

Patient Health Questionnaire - 9 items (PHQ-9)

时间窗: Change from Baseline to post (3mths).

次要结局

  • Quick Inventory of Depressive Symptoms - Self-Rreport (QIDS-SR16)(Baseline, post (3 mths), follow-up (6 mths))
  • Generalized Anxiety Disorder - 7 (GAD-7)(Baseline, post (3 mths), follow-up (6 mths))
  • Patient Health Questionnaire - 15 items (PHQ-15)(Baseline, post (3 mths), follow-up (6 mths))
  • Short Form Health Survey - 12 (SF-12)(Baseline, post (3 mths), follow-up (6 mths))

研究者

发起方
University of Luebeck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philipp Klein

Dr. med.

University of Luebeck

研究点 (4)

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