The Efficacy of Automated Feedback After Internet-based Depression Screening: the German, Three-armed, Randomised Controlled Trial DISCOVER
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 1178
- Locations
- 1
- Primary Endpoint
- Depression severity (Questionnaire: Patient Health Questionnaire-9)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Dr. Sebastian Kohlmann
Senior Researcher
Universitätsklinikum Hamburg-Eppendorf
Eligibility Criteria
Inclusion Criteria
- •(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
Exclusion Criteria
- •Diagnosis of a depressive disorder within the past 12 months
- •Depression treatment (current or within the past 12 months)
Outcomes
Primary Outcomes
Depression severity (Questionnaire: Patient Health Questionnaire-9)
Time Frame: 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.
Secondary Outcomes
- 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)