The Efficacy of Automated Feedback After Internet-based Depression Screening
DISCOVER
1 other identifier
interventional
1,178
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
November 18, 2020
CompletedStudy Start
First participant enrolled
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedSeptember 21, 2023
September 1, 2023
1.7 years
November 6, 2020
September 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression severity (Questionnaire: Patient Health Questionnaire-9)
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.
Six months after screening
Secondary Outcomes (9)
Depression severity (Questionnaire: Patient Health Questionnaire-9)
One month after screening
Guideline-based depression care
Six months after screening
Depression-related help-seeking behaviour
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
- +4 more secondary outcomes
Other Outcomes (5)
Illness beliefs (Questionnaire: Brief-Illness Perception Questionnaire)
One and six months after screening
Depression Diagnosis (Structured Clinical Interview for DSM-5 Disorders; depression-related module)
Two days and six months after screening
Critical life events
Six months after screening
- +2 more other outcomes
Study Arms (3)
tailored feedback
EXPERIMENTALUsing a randomized-controlled study design one third of the participants will receive individually tailored feedback after depression screening. The feedback for the participant contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment. The information is tailored to the participant's individual symptom profile, illness perceptions and preferences.
standardized feedback
EXPERIMENTALUsing a randomized-controlled study design one third of the participants will receive a standard feedback after depression screening. The feedback for the participant contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment.
no feedback
NO INTERVENTIONUsing a randomized-controlled study design one third of the participants will not receive any feedback.
Interventions
The feedback for the participant contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment. The information is tailored to the participant's individual symptom profile, illness perceptions and preferences.
The feedback for the participant contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment.
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- Diagnosis of a depressive disorder within the past 12 months
- Depression treatment (current or within the past 12 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitätsklinikum Hamburg-Eppendorflead
- German Research Foundationcollaborator
Study Sites (1)
University Medical Center Hamburg
Hamburg, 20246, Germany
Related Publications (3)
Sikorski F, Konig HH, Wegscheider K, Zapf A, Lowe B, Kohlmann S. The efficacy of automated feedback after internet-based depression screening: Study protocol of the German, three-armed, randomised controlled trial DISCOVER. Internet Interv. 2021 Jul 21;25:100435. doi: 10.1016/j.invent.2021.100435. eCollection 2021 Sep.
PMID: 34401394BACKGROUNDSikorski F, Lowe B, Daubmann A, Kohlmann S. Potential Harms of Feedback After Web-Based Depression Screening: Secondary Analysis of Negative Effects in the Randomized Controlled DISCOVER Trial. J Med Internet Res. 2025 Apr 30;27:e59476. doi: 10.2196/59476.
PMID: 40305104DERIVEDKohlmann S, Sikorski F, Konig HH, Schutt M, Zapf A, Lowe B. The efficacy of automated feedback after internet-based depression screening (DISCOVER): an observer-masked, three-armed, randomised controlled trial in Germany. Lancet Digit Health. 2024 Jul;6(7):e446-e457. doi: 10.1016/S2589-7500(24)00070-0.
PMID: 38906611DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Kohlmann, PhD
University Medical Center Hamburg-Eppendorf, Department of Psychosomatic Medicine and Psychotherapy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
November 6, 2020
First Posted
November 18, 2020
Study Start
January 12, 2021
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will become available six months after publication of the main findings. Data will be available for ten years after publication of the main findings.
- Access Criteria
- Data can be requested by the principal investigators. Data use and request are subject to the publication policy of the DISCOVER RCT.
In accordance with the ethics approval of the Ethics Committee of the Hamburg Medical Association on 29 July 2019, (approval number PV7039) and the German Research Foundation guidelines for the handling of research data, deidentified data will be made available on request.