The Efficacy of Automated Feedback After Internet-based Depression Screening (DISCOVER)

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Major Depressive Disorder; Depression

Treatments: Behavioral: tailored feedback of depression screening results; Behavioral: standardized feedback of depression screening results

Study type: Interventional

Funder types: Other

Identifiers

NCT04633096

PV7039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,178 participants in 3 patient groups

tailored feedback

Experimental group

Description:

Using 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.

Treatment:

Behavioral: tailored feedback of depression screening results

standardized feedback

Experimental group

Description:

Using 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.

Treatment:

Behavioral: standardized feedback of depression screening results

no feedback

No Intervention group

Description:

Using a randomized-controlled study design one third of the participants will not receive any feedback.