Clinical trial NCT04633096: The Efficacy of Automated Feedback After Internet-based Depression Screening
Official title: The Efficacy of Automated Feedback After Internet-based Depression Screening: the German, Three-armed, Randomised Controlled Trial DISCOVER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Major Depressive Disorder
Keywords: Depression
Screening
Tailored feedback
Internet-based intervention
Early Detection
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2020-11-18
Enrollment: 1178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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.

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)

Primary outcomes:
measure: Depression severity (Questionnaire: Patient Health Questionnaire-9)
timeFrame: Six months after screening
Secondary outcomes:
measure: Depression severity (Questionnaire: Patient Health Questionnaire-9)
timeFrame: One month after screening
measure: Guideline-based depression care
timeFrame: Six months after screening
measure: Depression-related help-seeking behaviour
timeFrame: Six months after screening
measure: Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory)
timeFrame: Six months after screening
measure: Health-related quality of life (Questionnaire: EuroQol-5D)
timeFrame: Six months after screening
measure: Anxiety (Questionnaire: Generalized Anxiety Disorder-7)
timeFrame: Six months after screening
measure: Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8)
timeFrame: Six months after screening
measure: Intervention acceptance (Questionnaire: Usefulness scale for patient information material)
timeFrame: One month after screening
measure: Adverse events
timeFrame: Six months after screening
Other outcomes:
measure: Illness beliefs (Questionnaire: Brief-Illness Perception Questionnaire)
timeFrame: One and six months after screening
measure: Depression Diagnosis (Structured Clinical Interview for DSM-5 Disorders; depression-related module)
timeFrame: Two days and six months after screening
measure: Critical life events
timeFrame: Six months after screening
measure: Website use
timeFrame: At baseline
measure: Intervention adherence
timeFrame: Six months after screening
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Department of Psychosomatic Medicine and Psychotherapy
name: Sebastian Kohlmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.