Management of Depression in Primary Care

Study Overview
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Brief Summary
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Most people in Sweden with mild to moderate depression are treated in primary care, but follow-up is unstructured, and we know little about whether structured, follow-up would affect the prognosis for depression and working life. The purpose of this study is to determine the effectiveness of regular, structured, patient-centered visits on mild to moderate depression.

Official Title
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Management of Depression in Primary Health Care: a Controlled Trial on the Effectiveness of Regular, Structured, Patient-centered Visits

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Structured patient-centered follow up of depression


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age 18 years and up Attends a participating primary health care center in the region Diagnosis of mild/moderate depressive disorder (new episode) No change in possible antidepressant maintenance therapy during the preceding 1 month Provided written informed consent Exclusion criteria Antidepressant medication initiated or changed during the preceding 1 month Patient diagnosed with major depressive disorder (BDI-II >28) Patients diagnosed of severe mental psychiatric disorder (i.e. bipolar disorder, antisocial personality disorder, psychosis, substance use disorder or other serious mental disorder) Suicidal ideation or intentions Inability to speak and understand Swedish language well enough to take part in the activities required in the study. Cognitive impairment that makes it impossible to take part in the activities required in the study Does not provide written informed consent to participation in the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Structured patient visits<br>Participants in the intervention group visit their general practitioner at baseline and 4, 8, and 12 weeks. At each visit, participants complete MADRS-s for the assessment of depression severity and discuss the results with their GP in a patient-centered consultation. | Behavioral: Structured patient-centered follow up of depression<br>* All patients who agree to participate in the study are diagnosed by their GP with a diagnostic assessment instrument called PRIME-MD. Participants in the intervention group visit their GPs at baseline and 4, 8, and 12 weeks. At each visit, participants complete MADRS-s for the assessment of depression severity and discuss the results with their GP in a patient-centered consultation. We have chosen to use the MADRS/MADRS-S depression rating scale in this study because it is a easy to use standard instrument especially suitable for measuring change in depressive symptoms. The control group receives treatment as usual (no intervention).<br>* Other names: MADRS/MADRS-S depression rating scale;|
| Other: Treatment as usual<br>The control group receives treatment as usual by general practitioner (no intervention). | Behavioral: Structured patient-centered follow up of depression<br>* All patients who agree to participate in the study are diagnosed by their GP with a diagnostic assessment instrument called PRIME-MD. Participants in the intervention group visit their GPs at baseline and 4, 8, and 12 weeks. At each visit, participants complete MADRS-s for the assessment of depression severity and discuss the results with their GP in a patient-centered consultation. We have chosen to use the MADRS/MADRS-S depression rating scale in this study because it is a easy to use standard instrument especially suitable for measuring change in depressive symptoms. The control group receives treatment as usual (no intervention).<br>* Other names: MADRS/MADRS-S depression rating scale;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depressive symptoms | Depressive symptoms will be assessed using the Beck Depression Inventory (BDI-II), a self-administered questionnaire that measures the symptoms and severity of the depression. | 3, 6 and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life | Each patient's quality of life will be assessed using the EuroQoL-5D questionnaire that measures five dimensions of quality of life | 3, 6 and 12 months | 
| Prescriptions for antidepressants | Information on Antidepressant use will be collected from patient records from start of the study and the 12-month follow-up period | 12-month follow-up period | 
| Change in Activity/work ability | Will be measured by Work Ability Index (WAI) and the Karaseks Job Strain Model Questionnaire. The Work Ability Index is used for evaluating people's work capacity and Karaseks Job Strain Model Questionnaire is used for evaluating Demands-Control in work place | 12-month follow-up period | 
| sick-listing data | Data on sick-listing is derived from primary care record fom baseline to 3 months follow up and from patient interview from 3 to 12 months | 12 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Intervention, Primary health care