Management of Depression in Primary Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Göteborg University
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01402206
First received: June 27, 2011
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Depression
Behavioral: Structured patient-centered follow up of depression

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Management of Depression in Primary Health Care: a Controlled Trial on the Effectiveness of Regular, Structured, Patient-centered Visits

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Change in Depressive symptoms [ Time Frame: 3, 6 and 12 months. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12-month follow-up period ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12-month follow-up period ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 month follow up ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 160
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MADRS/MADRS-S depression rating scale
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 Name: MADRS/MADRS-S depression rating scale

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402206

Contacts
Contact: Cecila Björkelund, Professor +46 (0) 31786 68 32 cecilia.bjorkelund@allmed.gu.se

Locations
Sweden
University of Gothenburg Recruiting
Gothenburg, Sweden
Contact: Cecila Björkelund, Professor    +46 (0)31786 68 32    cecilia.bjorkelund@allmed.gu.se   
Principal Investigator: Cecila Björkelund, Professor         
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Investigators
Principal Investigator: Cecila Björkelund, Professor Göteborg University
  More Information

Additional Information:
No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01402206     History of Changes
Other Study ID Numbers: Madrs 2010
Study First Received: June 27, 2011
Last Updated: June 25, 2014
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Göteborg University:
Depression
Intervention
Primary health care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014