- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Gothenburg, Schweden
- University of Gothenburg
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Sonstiges: 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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Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in Depressive symptoms
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Quality of life
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Cecila Björkelund, Professor, Göteborg University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Madrs 2010
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