The Efficacy of Web-based Feedback After Depression Screening

Overview

The DISCOVER randomized controlled trial is designed to evaluate the effect of individual-targeted feedback after (positive) depression screening in the broader setting of the internet. A total of 1076 individuals reporting elevated levels of depression (PHQ-9 score ≥ 10) will be randomized into three groups who either receive a) an individually tailored web-based feedback of depression screening results, b) a standard web-based feedback of depression screening results only, or c) no feedback of screening results. The primary study outcome is depression severity after 6 months, secondary outcomes include the patients' help-seeking behaviours after the intervention, depression care according to German guideline recommendations, the health economic evaluation and further clinical outcomes (somatic symptom severity and anxiety).

Full Title of Study: “The Efficacy and Cost-effectiveness of Web-based Feedback After Depression Screening: the DISCOVER Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Screening
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2022

Detailed Description

Major depressive disorder (MDD) is a highly prevalent condition associated with substantial disease burden and economic costs. Still, it is under recognized and thus often remains untreated, which in turn increases the likelihood of a chronic course, treatment resistance and rising healthcare costs. One solution to this could be improving the early detection of MDD by depression screening. Our previous trial in cardiac patients provides first evidence that depression screening combined with written individual-targeted feedback of 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 web-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) an individually tailored web-based feedback of depression screening results, b) a standard web-based feedback of depression screening results only, or c) no feedback of screening results. The primary study outcome is depression severity after 6 months, secondary outcomes include the patients' help-seeking behaviour after the intervention, depression care according to German guideline recommendations, the health economic evaluation and further clinical outcomes (somatic symptom severity and anxiety).

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • No Intervention: no feedback
    • Using a randomized-controlled study design one third of the participants will not receive any feedback.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Depression severity (Questionnaire: Patient Health Questionnaire-9)
    • Time Frame: One month 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.
  • Depression treatment according to the German national guideline for depression
    • Time Frame: Six months after screening
    • Proportion of individuals treated according to German Guideline based recommendations
  • Depression-related help-seeking behaviour
    • Time Frame: Six months after screening
    • Number of individuals seeking formal and informal help, including information seeking, self-help, online help, professional help.
  • New diagnosis of major depressive disorder
    • Time Frame: Six months after screening
    • Proportion of individuals that received a diagnosis of major depressive disorder
  • 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 counting the visits by doctors, clinics, alternative therapies, etc.
  • Quality-adjusted life years (Questionnaire: EuroQol-5D)
    • Time Frame: Six months after screening
    • Quality-adjusted years of life and 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.
  • 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.
  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Gender: male, female, diverse – Age ≥ 18 years; no maximum age – Sufficient German language skills – Informed consent – Patient Health Questionnaire-9 > 9 points Exclusion Criteria:

  • Known diagnosis of a depressive disorder – Current depression treatment – Not being able to fill out questionnaires – No internet access – No contact details

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitätsklinikum Hamburg-Eppendorf
  • Collaborator
    • German Research Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Sebastian Kohlmann, Senior Researcher – Universitätsklinikum Hamburg-Eppendorf
  • Overall Official(s)
    • Sebastian Kohlmann, PhD, Principal Investigator, University Medical Center Hamburg-Eppendorf, Department of Psychosomatic Medicine and Psychotherapy
  • Overall Contact(s)
    • Sebastian Kohlmann, PhD, +49 40 7410 54321, s.kohlmann@uke.de

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