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Primary Prevention of Major Depression Based on the Level and Profile of Risk of Primary Care Attenders: Cluster, Controlled, Randomised Trial (predictD-CCRT)

17. november 2014 oppdatert av: Juan Ángel Bellón Saameño, The Mediterranean Institute for the Advance of Biotechnology and Health Research
The main objective is to measure the effectiveness of a new intervention for primary prevention of major depression based on the level and profile of risk of primary care attendees. Among the secondary objectives is to evaluate the cost-effectiveness and cost-utility of the intervention versus usual care. METHODS: This is a cluster, randomised controlled trial of a community intervention with cluster at the level of practice. It will be undertaken in primary medical care in 7 Spanish cities and 5 autonomous communities.The aim is to evaluate a new intervention for primary prevention of major depression based on patients' level and profile of risk. Family doctors in the intervention practices will provide the intervention for patients at risk. Patients at risk who are recruited in control practices will receive usual primary care. The main outcome is the accumulated incidence of major depression (measured by CIDI) during the follow-up. The investigators will assess main outcomes and other covariables at baseline, 6, 12, and 18 months. A random sample of 3,381 primary care attendees (1,690 for each arm), aged 18-75 and without major depression will be recruited in 70 health centres (140 family doctors) in 7 cities. The investigators shall undertake a logistic regression multilevel model with 4 levels (time, patient, doctor and health centre). The investigators shall also undertake multivariate gamma and quantile regression to assess respectively the cost-effectiveness and cost-utility of the new intervention versus usual care, estimating their standard errors by bootstrap.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

3326

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • Málaga, Spania
      • Málaga, Spania, 29009
        • Servicio Andaluz de Salud. Distrito Sanitario Málaga

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients among those attending to primary care centers.

Exclusion Criteria:

  • Age under 18 or over 75 years.
  • Unable to understand or speak Spanish.
  • Represented patients (that is, someone else comes to visit on behalf of the patient).
  • Cognitive impairment.
  • Psychosis.
  • Terminal illness.
  • Planning to be outside of the the city during 4 or more months during the next 18 months.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Psychosocial Intervention

The intervention we propose to test has 3 actives components. The first one is the fact of giving information to the GPs about the level and risk profile of depression of their patients. The second one is the transmission of this information from the GP to the patient. The third one is the interaction GP/Patient once both have the information about the risk profile of depression and the psychoeducational intervention that the GP will provide to the patient.

We will develop psychoeducational booklet, DVDs and websites for patients included in the intervention group.

The psychoeducative intervention will be tailored to each patient based on his/her profile, risk level and patients' risk factors.

The GPs will receive a 20-hours training course in the intervention. Moreover, we will assume a communitarian view, considering the patient as an active agent for change (empowerment). That is, GPs and patients will work together in order to promote patients' resources.
Atferdsmessig: Psychosocial Intervention

The intervention we propose to test has 3 actives components. The first one is the fact of giving information to the GPs about the level and risk profile of depression of their patients. The second one is the transmission of this information from the GP to the patient. The third one is the interaction GP/Patient once both have the information about the risk profile of depression and the psychoeducational intervention that the GP will provide to the patient.

We will develop psychoeducational booklet, DVDs and websites for patients included in the intervention group.

The psychoeducative intervention will be tailored to each patient based on his/her profile, risk level and patients' risk factors.

The GPs will receive a 20-hours training course in the intervention. Moreover, we will assume a communitarian view, considering the patient as an active agent for change (empowerment). That is, GPs and patients will work together in order to promote patients' resources.
Ingen inngripen: Usual Care
The kind of care that general practitioners usually provide when not knowing the level and risk profile of depression of the patients

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Accumulated incidence of major depression
Tidsramme: 18 months
18 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cost-effectiveness and cost-utility
Tidsramme: 18 months
To evaluate the cost-effectiveness and cost-utility of the intervention versus usual care.
18 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Mediterranean Institute for the Advance of Biotechnology and Health Research

Samarbeidspartnere

Carlos III Health Institute
Andaluz Health Service
Preventive Services and Health Promotion Research Network

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2010

Primær fullføring (Faktiske)

1. juli 2012

Studiet fullført (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først innsendt

25. juni 2010

Først innsendt som oppfylte QC-kriteriene

28. juni 2010

Først lagt ut (Anslag)

29. juni 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. november 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. november 2014

Sist bekreftet

1. november 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PS09/00081

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Kliniske studier på Psychosocial Intervention

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

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