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Depression | Management of Depression in Primary Care

Depression research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Structured patient-centered follow up of depressionAll 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).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Structured patient visitsParticipants 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.

Treatment as usualThe control group receives treatment as usual by general practitioner (no intervention).

Study Status

Completed

Start Date: March 2010

Completed Date: December 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change in Depressive symptoms

Secondary Outcome: Change in Quality of life

Study sponsors, principal investigator, and references

Principal Investigator: Cecila Björkelund, Professor

Lead Sponsor: Göteborg University

Collaborator: Vastra Gotaland Region

More information:https://clinicaltrials.gov/show/NCT01402206

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