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Management of Depression in Primary Care

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Structured patient-centered follow up of depression
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Depression, Intervention, Primary health care

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Gothenburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Structured patient visits

Treatment as usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
June 27, 2011
Last Updated
August 15, 2016
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT01402206
Brief Title
Management of Depression in Primary Care
Official Title
Management of Depression in Primary Health Care: a Controlled Trial on the Effectiveness of Regular, Structured, Patient-centered Visits
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Intervention, Primary health care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured patient visits
Arm Type
Other
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
The control group receives treatment as usual by general practitioner (no intervention).
Intervention Type
Behavioral
Intervention Name(s)
Structured patient-centered follow up of depression
Other Intervention Name(s)
MADRS/MADRS-S depression rating scale
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Depressive symptoms
Description
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.
Time Frame
3, 6 and 12 months.
Secondary Outcome Measure Information:
Title
Change in Quality of life
Description
Each patient's quality of life will be assessed using the EuroQoL-5D questionnaire that measures five dimensions of quality of life
Time Frame
3, 6 and 12 months
Title
Prescriptions for antidepressants
Description
Information on Antidepressant use will be collected from patient records from start of the study and the 12-month follow-up period
Time Frame
12-month follow-up period
Title
Change in Activity/work ability
Description
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
Time Frame
12-month follow-up period
Title
sick-listing data
Description
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
Time Frame
12 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecila Björkelund, Professor
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Gothenburg
City
Gothenburg
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28103816
Citation
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.
Results Reference
derived

Learn more about this trial

Management of Depression in Primary Care

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