- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Gothenburg, Sverige
- University of Gothenburg
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: 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).
Andre navne:
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Andet: 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).
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Depressive symptoms
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Quality of life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cecila Björkelund, Professor, Göteborg University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Madrs 2010
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