ClinicalTrials.gg
CompletedNCT01402206Updated Aug 16, 2016

Management of Depression in Primary Care

An interventional study of Structured patient-centered follow up of depression in Depression, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-08-16.

Sponsored by Göteborg University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
258
Allocation
Non-randomized
Ages
20 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Depression

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Keywords

  • Depression
  • Intervention
  • Primary health care
03

In context

Depression

8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 258 is above the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Göteborg University is the lead sponsor of 270 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
258 participants (actual)

Study arms

  • 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

  • Other
    Treatment as usual

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

    Behavioral: Structured patient-centered follow up of depression

Interventions

  • BehavioralStructured 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).

    Also known as: MADRS/MADRS-S depression rating scale

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3, 6 and 12 months.

Secondary outcomes

  1. 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

    Time frame: 3, 6 and 12 months

  2. 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

    Time frame: 12-month follow-up period

  3. 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

    Time frame: 12-month follow-up period

  4. 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

    Time frame: 12 month follow up

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Study locations

1 site
  • University of Gothenburg
    Gothenburg, Sweden
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References and documents

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. PubMed 28103816 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01402206
Responsible party
Sponsor
First posted
Jul 26, 2011
Start date
Mar 2010
Primary completion
Dec 2013
Completion
Dec 2014
Last update
Aug 16, 2016

Study contacts

Cecila Björkelund, Professor
principal investigator · Göteborg University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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