NCT01402206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

3.8 years

First QC Date

June 27, 2011

Last Update Submit

August 15, 2016

Conditions

Depression

Keywords

DepressionInterventionPrimary health care

Outcome Measures

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.

    3, 6 and 12 months.

Secondary Outcomes (4)

  • Change in Quality of life

    3, 6 and 12 months

  • Prescriptions for antidepressants

    12-month follow-up period

  • Change in Activity/work ability

    12-month follow-up period

  • sick-listing data

    12 month follow up

Study Arms (2)

Structured patient visits

OTHER

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

Treatment as usual

OTHER

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

Behavioral: Structured patient-centered follow up of depression

Interventions

Structured patient-centered follow up of depressionBEHAVIORAL

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
Structured patient visitsTreatment as usual

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg

Gothenburg, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 28103816DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Cecila Björkelund, Professor

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2011

First Posted

July 26, 2011

Study Start

March 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

SE(1)