AzTrials
AzTrials

DepressionDISCOVERNCT04633096

The Efficacy of Automated Feedback After Internet-based Depression Screening

A study testing tailored feedback of depression screening results and standardized feedback of depression screening results in people with Depression and Major Depressive Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Major Depressive Disorder
What is being tested?
tailored feedback of depression screening results and standardized feedback of depression screening results
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,178 participants
Where
1 siteGermany
Study dates
12 Jan 2021to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medical Center Hamburg

    Hamburg, 20246

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
tailored feedback of depression screening results, standardized feedback of depression screening results
Keywords
Depression, Screening, Tailored feedback, Internet-based intervention, Early Detection
Medical subject headings
Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tailored feedback of depression screening resultsBehavioural

    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 of depression screening resultsBehavioural

    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.

Study groups in NCT04633096
Study groupRoleWhat they receive
tailored feedbackExperimentalUsing 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.
Receives: Behavioral: tailored feedback of depression screening results
standardized feedbackExperimentalUsing 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.
Receives: Behavioral: standardized feedback of depression screening results
no feedbackNo interventionUsing a randomized-controlled study design one third of the participants will not receive any feedback.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Six months after screening

Secondary outcomes (9)

  1. Depression severity (Questionnaire: Patient Health Questionnaire-9)

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

    Measured: One month after screening

  2. Guideline-based depression care

    Proportion of individuals treated according to German Guideline based recommendations (e.g. depression diagnosis by a health professional, psychotherapy)

    Measured: Six months after screening

  3. Depression-related help-seeking behaviour

    proportion of individuals seeking formal and informal help, including information seeking, self-help, online help, professional help.

    Measured: Six months after screening

  4. Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory)

    Health care use assessed six months after screening with the Client Sociodemographic and Service Receipt Inventory. The Client Sociodemographic and Service Receipt Inventory assesses health care use by assessing the use of healthcare services (e.g. hospital stays, health professional contacts), medication (e.g. type of drug) and work loss days (e.g. hospital days)

    Measured: Six months after screening

  5. Health-related quality of life (Questionnaire: EuroQol-5D)

    Health-related quality of life assessed six months after screening with the EuroQol-5D. The EuroQol-5D (EQ5D) consists of five items with a 4 point Likert scale reflecting five different dimensions of quality of life. Higher scores reflect better quality of life.

    Measured: Six months after screening

  6. Anxiety (Questionnaire: Generalized Anxiety Disorder-7)

    Level of anxiety assessed six months after screening with the Generalized Anxiety Disorder-7. Score range is 0 to 21 points. Higher scores mean more anxiety.

    Measured: Six months after screening

  7. Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8)

    Level of somatic symptom severity assessed six months after screening with the Somatic Symptom Scale.8. Score range is 0 to 32 points. Higher scores mean more somatic symptom burden.

    Measured: Six months after screening

  8. Intervention acceptance (Questionnaire: Usefulness scale for patient information material)

    Usefulness and satisfaction with the feedback intervention material will be assessed one month after screening with the Usefulness Scale for patient information material. Score range is 0 to 100 points. Higher scores mean better usefulness. Items are added to assess PHQ-9-based depression screening.

    Measured: One month after screening

  9. Adverse events

    Proportion of individuals reporting the occurence of any negative event that is attributed to the trial assessed by one open question six months after screening

    Measured: Six months after screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start12 Jan 2021
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04633096
Sponsor's protocol ID
PV7039
Acronym
DISCOVER
Status last verified
Sep 2023
First submitted
6 Nov 2020
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34401394

  • Kreis LG, Konig HH, Sikorski F, Lowe B, Kohlmann S, Brettschneider C. Automated Feedback After Internet-Based Depression Screening: Cost-Effectiveness Analysis of a Randomized Controlled Trial. JMIR Form Res. 2025 Dec 23;9:e68282. doi: 10.2196/68282.

    PubMed 41433057

  • Sikorski 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.

    PubMed 40305104

  • Kohlmann 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.

    PubMed 38906611

Questions about this trial

What is this clinical trial studying?

A study testing tailored feedback of depression screening results and standardized feedback of depression screening results in people with Depression and Major Depressive Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression severity (Questionnaire: Patient Health Questionnaire-9) (time frame: Six months after screening). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04633096, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in