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- Klinische proef NCT01402206
Management of Depression in Primary Care
Management of Depression in Primary Health Care: a Controlled Trial on the Effectiveness of Regular, Structured, Patient-centered Visits
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Gothenburg, Zweden
- University of Gothenburg
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: 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.
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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).
Andere namen:
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Ander: Treatment as usual
The control group receives treatment as usual by general practitioner (no intervention).
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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).
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Depressive symptoms
Tijdsspanne: 3, 6 and 12 months.
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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.
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3, 6 and 12 months.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Quality of life
Tijdsspanne: 3, 6 and 12 months
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Each patient's quality of life will be assessed using the EuroQoL-5D questionnaire that measures five dimensions of quality of life
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3, 6 and 12 months
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Prescriptions for antidepressants
Tijdsspanne: 12-month follow-up period
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Information on Antidepressant use will be collected from patient records from start of the study and the 12-month follow-up period
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12-month follow-up period
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Change in Activity/work ability
Tijdsspanne: 12-month follow-up period
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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
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12-month follow-up period
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sick-listing data
Tijdsspanne: 12 month follow up
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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
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12 month follow up
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Cecila Björkelund, Professor, Göteborg University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Madrs 2010
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