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Management of Depression in Primary Care

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ClinicalTrials.gov Identifier: NCT01402206
Recruitment Status : Completed
First Posted : July 26, 2011
Last Update Posted : August 16, 2016
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University

Tracking Information
First Submitted Date  ICMJE June 27, 2011
First Posted Date  ICMJE July 26, 2011
Last Update Posted Date August 16, 2016
Study Start Date  ICMJE March 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01402206 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2012)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • 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
  • Change in Overall functioning [ Time Frame: 3, 6 and 12 months ]
    Global Assessment of Functioning Scale (GAF) will be used to assess overall functioning (ability to carry out activities of daily living).
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Depression in Primary Care
Official Title  ICMJE Management of Depression in Primary Health Care: a Controlled Trial on the Effectiveness of Regular, Structured, Patient-centered Visits
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Depression
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Structured patient-centered follow up of depression
  • Treatment as usual
    The control group receives treatment as usual by general practitioner (no intervention).
    Intervention: Behavioral: Structured patient-centered follow up of depression
Publications * Wikberg C, Westman J, Petersson EL, Larsson ME, André M, Eggertsen R, Thorn J, Ågren H, Björkelund 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2016)
258
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2011)
160
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01402206
Other Study ID Numbers  ICMJE Madrs 2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Göteborg University
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE Vastra Gotaland Region
Investigators  ICMJE
Principal Investigator: Cecila Björkelund, Professor Göteborg University
PRS Account Göteborg University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP