The Efficacy of Automated Feedback After Internet-based Depression Screening: the German, Three-armed, Randomised Controlled Trial DISCOVER
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
- 否
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
Dr. Sebastian Kohlmann
Senior Researcher
Universitätsklinikum Hamburg-Eppendorf
