Motiverende gespreksvoering om middelengebruik bij depressiepatiënten te verminderen
8 juni 2015 bijgewerkt door: University of California, San Francisco
De studie heeft tot doel de effectiviteit te evalueren van een interventie om alcohol- en drugsgebruik en depressiesymptomen te verminderen, de functionele status te verbeteren en een passend gebruik van de gezondheidszorg te bevorderen, in een steekproef van 300 volwassenen die een behandeling voor depressie zoeken en die ook melden dat ze gevaarlijk drinken of drugs gebruiken met een depressie. .
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Deze studie behandelt belangrijke vragen met betrekking tot het identificeren en behandelen van patiënten in de psychiatrie die zich aanmelden voor diensten met alcohol- of drugsgebruik dat depressie kan verergeren.
De onderzoekers stellen een studie voor van Brief Motivational Intervention (BMI) om het drugs- en alcoholgebruik bij patiënten met een depressie te verminderen en om de betrokkenheid bij een Kaiser Chemical Dependency Recovery Program (CDRP) waar nodig te vergroten.
Patiënten met een depressie die drugs of alcohol gebruiken, zelfs op subdiagnostische niveaus, lopen een hoog risico op escalatie van middelenproblemen.
BMI is een innovatieve, evidence-based benadering die het gebruik van drugs en alcohol kan verminderen en de resultaten kan verbeteren.
Maar het is niet getest bij depressiepatiënten.
Deze onderzoekssteekproef omvat 300 poliklinische patiënten in behandeling voor depressie in Kaiser Permanente Noord-Californië Hayward/Fremont Psychiatry.
Inclusiecriteria zijn gebaseerd op drugsgebruik (elk illegaal drugsgebruik en niet-voorgeschreven gebruik van voorgeschreven medicijnen) en gevaarlijk drinken (d.w.z. ≥ 3 drankjes per dag voor vrouwen en ≥ 4 drankjes per dag voor mannen), en matig tot ernstig depressiesymptomen bij intake.
Driehonderd patiënten worden gerandomiseerd en krijgen één persoonlijke BMI-sessie en twee telefonische BMI-sessies binnen 6 weken na intake (interventie) of een brochure over de risico's van drugs- en alcoholgebruik (controle).
De onderzoekers verwachten dat de interventie effectief zal zijn bij het verminderen van de frequentie van drugsgebruik en gevaarlijk drinken bij telefonische follow-up-interviews van 3, 6 en 12 maanden; verbetering van de stemming en functionele resultaten; toenemende retentie van depressiebehandelingen (aantal psychiatrische bezoeken, gebaseerd op Healthcare Effectiveness Data and Information Set (HEDIS)-normen); en het vergemakkelijken van de start van de behandeling door de patiënt van een programma voor chemische afhankelijkheid, indien nodig, en zal kosteneffectief zijn.
Voor de verbetering van de patiëntenzorg zal het ook belangrijke informatie opleveren over de integratie van alcohol- en drugsinterventie in de psychiatrie en hoe patiënten het beste kunnen worden geholpen toegang te krijgen tot gespecialiseerde CDRP-diensten wanneer dat nodig is.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
307
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Union City, California, Verenigde Staten, 94545
- Kaiser Permanente Medical Center Southern Alameda County
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusiecriteria:
- Gevaarlijk drinken (d.w.z. ≥ 3 drankjes per dag voor vrouwen en ≥ 4 drankjes per dag voor mannen)
- Drugsgebruik (inclusief elk gebruik van illegale drugs en niet-voorgeschreven gebruik van geneesmiddelen op recept in de voorafgaande 30 dagen)
- Matige of sterkere symptomen van depressie op basis van een score van ≥ 5 op de Patient Health Questionnaire (PHQ-9)
Uitsluitingscriteria:
- Huidige manie of psychose
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Motiverende gespreksvoering
De motiverende gespreksvoering (MI)-interventie bestond uit een persoonlijke MI-sessie van 45 minuten, gevolgd door twee telefonische "booster"-sessies van 15 minuten
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Actieve vergelijker: Controle
Deelnemers ontvingen een brochure over de risico's van alcohol- en drugsgebruik.
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Deelnemers ontvingen een brochure over de risico's van alcohol- en drugsgebruik.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Gevaarlijk drinken in de afgelopen 30 dagen (zelfgerapporteerd aantal dagen gevaarlijk drinken)
Tijdsspanne: 6 maanden
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Zelfgerapporteerd aantal dagen van gevaarlijk drinken (3+ drankjes per dag voor vrouwen / 4+ drankjes per dag voor mannen) in de voorafgaande 30 dagen.
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6 maanden
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Drugsgebruik in de afgelopen 30 dagen (zelfgerapporteerd aantal dagen drugsgebruik)
Tijdsspanne: 6 maanden
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Zelfgerapporteerd aantal dagen drugsgebruik (illegaal drugsgebruik of misbruik van geneesmiddelen op recept) in de 30 voorgaande dagen.
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6 maanden
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Gevaarlijk drinken in de afgelopen 30 dagen (zelfgerapporteerd aantal dagen gevaarlijk drinken)
Tijdsspanne: 12 maanden
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Zelfgerapporteerd aantal dagen van gevaarlijk drinken (3+ drankjes per dag voor vrouwen / 4+ drankjes per dag voor mannen) in de voorafgaande 30 dagen.
We onderzoeken de verandering tussen gebruik na 6 maanden en gebruik na 12 maanden om de interventie-impact op lange termijn te meten.
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12 maanden
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Drugsgebruik in de afgelopen 30 dagen (zelfgerapporteerd aantal dagen drugsgebruik)
Tijdsspanne: 12 maanden
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Zelfgerapporteerd aantal dagen drugsgebruik (illegaal drugsgebruik of misbruik van geneesmiddelen op recept) in de 30 voorgaande dagen.
We onderzoeken de verandering in gebruik tussen 6 maanden en 12 maanden om de impact van de interventie op lange termijn te meten.
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12 maanden
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Depressiesymptomen (score patiëntgezondheidsvragenlijst (PHQ-9))
Tijdsspanne: 12 maanden
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gemeten tijdens telefonische follow-up interviews. De PHQ-9 beoordeelt de frequentie van 9 soorten problemen in de afgelopen 2 weken; antwoorden variëren van 0 (helemaal niet) tot 3 (bijna elke dag).
Als ten minste 4 van de 9 >0 zijn, wordt de som van de itemscores gebruikt om de ernst van de depressie aan te geven: 1-4 minimaal; 5-9 Mild; 10-14 Matig; 15-19 Matig ernstig; 20-27 Ernstig.
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12 maanden
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Adequate geestelijke gezondheidszorg (aantal deelnemers dat 12 weken ononderbroken wordt behandeld op de Kaiser Permanente polikliniek psychiatrie)
Tijdsspanne: 3 maanden
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Aantal deelnemers dat 12 weken ononderbroken wordt behandeld op de afdeling polikliniek psychiatrie van Kaiser Permanente
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3 maanden
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Derek D Satre, PhD, University of California, San Francisco
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2010
Primaire voltooiing (Werkelijk)
1 augustus 2014
Studie voltooiing (Werkelijk)
1 augustus 2014
Studieregistratiedata
Eerst ingediend
7 april 2015
Eerst ingediend dat voldeed aan de QC-criteria
17 april 2015
Eerst geplaatst (Schatting)
20 april 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
10 juni 2015
Laatste update ingediend die voldeed aan QC-criteria
8 juni 2015
Laatst geverifieerd
1 juni 2015
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 10-03323
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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