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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Structured patient-centered follow up of depression

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • University of Gothenburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: 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).; Other Names: MADRS/MADRS-S depression rating scale
Other: Treatment as usual; The control group receives treatment as usual by general practitioner (no intervention).	Behavioral: 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).; Other Names: MADRS/MADRS-S depression rating scale

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Vastra Gotaland Region
• Investigators: Principal Investigator: Cecila Björkelund, Professor, Göteborg University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (Estimate): July 26, 2011

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Depression; Primary health care; Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: Madrs 2010