Major Depressive Disorder (MDD)

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of systematic screening for depression in high-risk patient participants in everyday clinical practice. Systematic screening for depression in high-risk patients is recommended to be included as a usual practice but its effectiveness in this context remains controversial. In this study, 35 primary care physicians (PCPs) in Spain were assigned to intervention (receive one day training in depression screening guidelines and use guidelines for six months) and 34 PCPs were assigned to a control group (manage depression in the usual way for six months). There were a total of 525 patient participants with MDD.

Official Title
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Effectiveness of Physicians' Education, Implementation and Follow up of Current Recommendations Regarding Screening for Major Depressive Disorder in High Risk Patients on Improving the Under-Recognition Rates of Depression in Primary Care

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Intervention
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCP Participants: PCPs informed of the study design and who agreed to be randomized to the intervention or control group Patient Participants: Aged 18 years or older who provide a written consent for the collection and use of their clinical data Exclusion Criteria: PCP Participants: If they already follow the recommendations on screening or were planning to do so. If they will be absent from their practice for a significant period during the study, or if they do not usually manage depression PCP Participants: Those who were not able to understand the aims of the study

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>Intervention group primary care physician (PCP) receives one day training in depression screening guidelines and uses guidelines for six months | Behavioral: Intervention<br>* PCP receives one day training in depression screening guidelines and uses guidelines for six months<br>|
| Control<br>Control group PCP manages depression in the usual way for six months | Behavioral: Control<br>* PCP manages depression in the usual way for six months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks |  | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks |  | 24 Weeks | 
| Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks |  | Baseline, 24 Weeks | 
| Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks |  | Baseline, 24 Weeks | 
| Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks |  | Baseline, 24 Weeks | 
| Mean Duration of Depressive Episodes in Patient Participants |  | 24 Weeks | 
| Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants |  | 24 Weeks | 
| Sheehan Disability Scale (SDS) Score in Patient Participants |  | 24 Weeks | 
| Mean Duration of Sick Leave Due to Depression in Patient Participants |  | 24 Weeks | 
| Percentage of Patient Participants with Sick Leave Due to Depression |  | 24 Weeks |