The Efficacy of Automated Feedback After Internet-based Depression Screening

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Major Depressive Disorder

Intervention / Treatment
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* Behavioral: tailored feedback of depression screening results
* Behavioral: standardized feedback of depression screening results


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tailored feedback<br>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<br>* 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.<br>|
| Experimental: standardized feedback<br>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<br>* 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.<br>|
| No Intervention: no feedback<br>Using a randomized-controlled study design one third of the participants will not receive any feedback. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression severity (Questionnaire: Patient Health Questionnaire-9) | 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. | Six months after screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression severity (Questionnaire: Patient Health Questionnaire-9) | 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. | One month after screening | 
| Guideline-based depression care | Proportion of individuals treated according to German Guideline based recommendations (e.g. depression diagnosis by a health professional, psychotherapy) | Six months after screening | 
| Depression-related help-seeking behaviour | proportion of individuals seeking formal and informal help, including information seeking, self-help, online help, professional help. | Six months after screening | 
| Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory) | 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) | Six months after screening | 
| Health-related quality of life (Questionnaire: EuroQol-5D) | 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. | Six months after screening | 
| Anxiety (Questionnaire: Generalized Anxiety Disorder-7) | 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. | Six months after screening | 
| Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8) | 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. | Six months after screening | 
| Intervention acceptance (Questionnaire: Usefulness scale for patient information material) | 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. | One month after screening | 
| Adverse events | 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 | Six months after screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Screening, Tailored feedback, Internet-based intervention, Early Detection