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Management of Depression in Primary Care

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01402206
Enrollment
258
Registered
2011-07-26
Start date
2010-03-31
Completion date
2014-12-31
Last updated
2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, Intervention, Primary health care

Brief summary

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.

Interventions

BEHAVIORALStructured patient-centered follow up of depression

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).

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Göteborg University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Depressive symptoms3, 6 and 12 months.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.

Secondary

MeasureTime frameDescription
Change in Quality of life3, 6 and 12 monthsEach patient's quality of life will be assessed using the EuroQoL-5D questionnaire that measures five dimensions of quality of life
Prescriptions for antidepressants12-month follow-up periodInformation on Antidepressant use will be collected from patient records from start of the study and the 12-month follow-up period
Change in Activity/work ability12-month follow-up periodWill 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
sick-listing data12 month follow upData 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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026