Management of Depression in Primary Care

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402206
• Other study ID #: Madrs 2010
• Status: Completed
• Phase: N/A
• First received: June 27, 2011
• Last updated: August 15, 2016
• Start date: March 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

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).

Locations

Country	Name	City	State
Sweden	University of Gothenburg	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Our homepage at University of Gothenburg (in swedish)