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Completed

NCT Number: NCT01402206

Management of Depression in Primary Care

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Gothenburg

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured patient-centered follow up of depression

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).

Other names: MADRS/MADRS-S depression rating scale

Primary outcomes

  1. Change in Depressive symptoms

    Time frame: 3, 6 and 12 months.

    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 outcomes

  1. Change in Quality of life

    Time frame: 3, 6 and 12 months

    Each patient's quality of life will be assessed using the EuroQoL-5D questionnaire that measures five dimensions of quality of life

  2. Prescriptions for antidepressants

    Time frame: 12-month follow-up period

    Information on Antidepressant use will be collected from patient records from start of the study and the 12-month follow-up period

  3. Change in Activity/work ability

    Time frame: 12-month follow-up period

    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

  4. sick-listing data

    Time frame: 12 month follow up

    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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jul 26, 2011
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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