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Completed

NCT Number: NCT04633096

The Efficacy of Automated Feedback After Internet-based Depression Screening

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

tailored feedback of depression screening results

Behavioral

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 results

Behavioral

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.

Primary outcomes

  1. 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

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

    Time frame: One month after screening

    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.

  2. Guideline-based depression care

    Time frame: Six months after screening

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

  3. Depression-related help-seeking behaviour

    Time frame: Six months after screening

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

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

    Time frame: Six months after screening

    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)

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

    Time frame: Six months after screening

    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.

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

    Time frame: Six months after screening

    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.

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

    Time frame: Six months after screening

    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.

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

    Time frame: One month after screening

    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.

  9. Adverse events

    Time frame: Six months after screening

    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

Other outcomes

  1. Illness beliefs (Questionnaire: Brief-Illness Perception Questionnaire)

    Time frame: One and six months after screening

    Depression-related illness beliefs assessed one and six months after screening with the Brief-Illness Perception Questionnaire. The Brief-Illness Perception Questionnaire includes 8 subscales (consequences, timeline, personal control, treatment control, illness comprehensibility, illness concern, illness-related emotions, causal attribution). Depending on each scale higher scores can represent functional or dysfunctional illness representations.

  2. Depression Diagnosis (Structured Clinical Interview for DSM-5 Disorders; depression-related module)

    Time frame: Two days and six months after screening

    Proportion of individuals with a depression diagnosis as assessed with the Structured Clinical Interview for DSM-5 Disorders (depression-related module)

  3. Critical life events

    Time frame: Six months after screening

    Positive and negative critical life events, assessed by open questions six months after screening

  4. Website use

    Time frame: At baseline

    Number of clicks per page

  5. Intervention adherence

    Time frame: Six months after screening

    Extent to which participants have read the feedback (in percentage), as reported by participants six months after screening

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

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

Acronym: DISCOVER

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2020
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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