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

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ClinicalTrials.gov Identifier: NCT04633096
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Dr. Sebastian Kohlmann, Universitätsklinikum Hamburg-Eppendorf

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depression Major Depressive Disorder Behavioral: tailored feedback of depression screening results Behavioral: standardized feedback of depression screening results Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1074 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: The Efficacy of Automated Feedback After Internet-based Depression Screening: the German, Three-armed, Randomised Controlled Trial DISCOVER
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: tailored feedback
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.
 Behavioral: tailored feedback of depression screening results
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.
Experimental: standardized feedback
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.
 Behavioral: standardized feedback of depression screening results
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 Intervention: no feedback
Using a randomized-controlled study design one third of the participants will not receive any feedback.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633096


Contacts
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Contact: Sebastian Kohlmann, PhD +49 40 7410 54321 s.kohlmann@uke.de
Contact: Bernd Löwe, MD +49 40 7410 53992 b.loewe@uke.de

Locations
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Germany
University Medical Center Hamburg Recruiting
Hamburg, Germany, 20246
Contact: Bernd Löwe, MD    +49 40-7410-59733    b.loewe@uke.de   
Contact: Sebastian Kohlmann, PhD    +49 40-7410-54321    s.kohlmann@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Research Foundation
Investigators
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Principal Investigator: Sebastian Kohlmann, PhD University Medical Center Hamburg-Eppendorf, Department of Psychosomatic Medicine and Psychotherapy
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Sebastian Kohlmann, Senior Researcher, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04633096    
Other Study ID Numbers: PV7039
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Sebastian Kohlmann, Universitätsklinikum Hamburg-Eppendorf:
Depression
Screening
Tailored feedback
Internet-based intervention
Early Detection
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders