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临床试验/NCT04633096
NCT04633096已完成不适用

The Efficacy of Automated Feedback After Internet-based Depression Screening: the German, Three-armed, Randomised Controlled Trial DISCOVER

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 1,178 人开始时间: 2021年1月12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
1,178
试验地点
2
主要终点
Depression severity (Questionnaire: Patient Health Questionnaire-9)

研究概览

简要总结

The DISCOVER randomized controlled trial is designed to evaluate the effect of automated feedback after internet-based depression screening in individuals with undetected depression. A total of 1076 individuals reporting elevated levels of depression (PHQ-9 score ≥ 10 points) will be randomized into three groups to either receive a) no feedback (control group), b) standardised or c) tailored feedback on their depression screening results.The primary hypothesis is that feedback reduces depression severity six months after screening compared to no feedback. The secondary hypothesis is that tailored feedback is more efficacious as compared to standard feedback.

详细描述

Major depressive disorder (MDD) is a highly prevalent condition associated with substantial disease burden and economic costs. Still, it often remains undetected and untreated, which in turn increases the likelihood of a chronic course, treatment resistance and rising healthcare costs. One solution to address early detection and disease burden could be widely accessible depression screening. Our previous trial in cardiac patients provides first evidence that depression screening combined with written individual-targeted feedback on the screening results improves depression severity and encourages greater patient participation and engagement in mental health. To amplify these effects in a broader setting, the internet-based DISCOVER randomized controlled trial (RCT) now aims at addressing affected but yet undetected individuals on the internet. In order to evaluate the effect of feedback in this setting, a total of 1076 individuals reporting elevated levels of depression (PHQ-9 score ≥ 10) will be randomized into three groups. They either receive a) no feedback (control group), b) standardised or c) tailored feedback on their depression screening results. The primary hypothesis is that feedback reduces depression severity six months after screening compared to no feedback. The secondary hypothesis is that tailored feedback is more efficacious as compared to standard feedback. Futher outcomes are guideline-based depression care, depression-related help-seeking behaviour, a health economic evaluation, clinical outcomes (somatic symptom severity and anxiety), health-related quality of life, illness beliefs, intervention acceptance, depression diagnosis and adverse events.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Screening
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • (Gender: male, female, diverse)
  • Age ≥ 18 years; no maximum age
  • Sufficient German language skills
  • Informed consent
  • Patient Health Questionnaire-9 > 9 points
  • Contact details
  • Internet access
  • Sufficient computer/internet literacy

排除标准

  • Diagnosis of a depressive disorder within the past 12 months
  • Depression treatment (current or within the past 12 months)

结局指标

主要结局

Depression severity (Questionnaire: Patient Health Questionnaire-9)

时间窗: Six months after screening

Level of depression severity assessed six months after screening with the Patient Health Questionnaire-9. Score range is 0 to 27 points. Higher scores mean more severe depression.

次要结局

  • Depression severity (Questionnaire: Patient Health Questionnaire-9)(One month after screening)
  • Depression-related help-seeking behaviour(Six months after screening)
  • Guideline-based depression care(Six months after screening)
  • Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory)(Six months after screening)
  • Health-related quality of life (Questionnaire: EuroQol-5D)(Six months after screening)
  • Anxiety (Questionnaire: Generalized Anxiety Disorder-7)(Six months after screening)
  • Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8)(Six months after screening)
  • Intervention acceptance (Questionnaire: Usefulness scale for patient information material)(One month after screening)
  • Adverse events(Six months after screening)

研究者

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

Dr. Sebastian Kohlmann

Senior Researcher

Universitätsklinikum Hamburg-Eppendorf

研究点 (2)

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