跳至主要内容
临床试验/DRKS00032121
DRKS00032121已完成3 期

Randomized controlled clinical trial of the efficacy of the digital self-help program edupression.com® in mild-to-moderate unipolar depressive patients - eFICASY-Study

Medizinische Universität Wien0 个研究点目标入组 250 人开始时间: 2023年8月4日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
250

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • Age 18-65 years
  • ICD-107 diagnosis of a mild to moderate depressive episode (F32.0, F32.1) or recurrent depressive disorder (F33.0, F33.1) based the M.I.N.I. diagnostic interview.
  • PHQ-9 depression severity score =5
  • available internet access
  • ability to be managed as outpatient.
  • informed consent and willingness to follow the study protocol including the ability to understand the instructions provided by edupression.com®

排除标准

  • previous or concurrent major medical or neurological illness
  • any history of non-response to either psychotherapy/eHealth interventions (min. 3 month) or medication (min. 6 weeks, adequate antidepressive drug dosing) or any kind of therapy resistance
  • participants in the active phase of other interventional studies
  • ICD-10 diagnosis of substance dependence within the past year, except for caffeine or nicotine
  • ICD-10 diagnosis of schizophrenia, schizoaffective disorder, bipolar affective disorder, persistent mood disorders, or an anxiety disorder
  • being acutely suicidal either indicated by a score =3 on item 9 (suicidal thoughts) on the PHQ-9 or according to the investigator´s opinion
  • inability to comply with the study protocol or to follow the instructions of the investigating team in accordance with the Declaration of Helsinki

研究者

相似试验