Management of Depression in Primary Care

NCT ID: NCT01402206

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-12-31

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.

Conditions

Depression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Structured patient visits

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.

Group Type: OTHER

Structured patient-centered follow up of depression

Intervention Type: BEHAVIORAL

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).

Treatment as usual

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

Group Type: OTHER

Structured patient-centered follow up of depression

Intervention Type: BEHAVIORAL

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).

Interventions

Structured 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).

Intervention Type: BEHAVIORAL

Other Intervention Names

MADRS/MADRS-S depression rating scale

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecila Björkelund, Professor

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

University of Gothenburg

Gothenburg, , Sweden

Countries

Sweden

References

Wikberg C, Westman J, Petersson EL, Larsson ME, Andre M, Eggertsen R, Thorn J, Agren H, Bjorkelund C. Use of a self-rating scale to monitor depression severity in recurrent GP consultations in primary care - does it really make a difference? A randomised controlled study. BMC Fam Pract. 2017 Jan 19;18(1):6. doi: 10.1186/s12875-016-0578-9.

Reference Type: DERIVED

PMID: 28103816 (View on PubMed)

Other Identifiers

Madrs 2010

Identifier Type: -

Identifier Source: org_study_id