- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Gothenburg, Svezia
- University of Gothenburg
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: 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.
|
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).
Altri nomi:
|
Altro: Treatment as usual
The control group receives treatment as usual by general practitioner (no intervention).
|
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).
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Depressive symptoms
Lasso di tempo: 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.
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3, 6 and 12 months.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Quality of life
Lasso di tempo: 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
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3, 6 and 12 months
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Prescriptions for antidepressants
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Cecila Björkelund, Professor, Göteborg University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Madrs 2010
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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