Støtte til peer-interaktioner for at udvide adgangen til digital kognitiv adfærdsterapi for spansktalende patienter (SUPERA)
15. maj 2026 opdateret af: Stephen Matthew Schueller, University of California, Irvine
SUPERA: Støtte til peer-interaktioner for at udvide adgangen til digital kognitiv adfærdsterapi for spansktalende sikkerhedsnetpatienter i primærpleje
Efterforskere vil evaluere implementeringen af en evidensbaseret, spansksproget, digital, kognitiv adfærdsterapiintervention (SilverCloud) i primære plejemiljøer for Latino-patienter med depression og/eller angst.
426 deltagere vil blive tilmeldt et to-armet forsøg, der sammenligner selv-guidet vs. understøttet dCBT (SilverCloud).
På udbyderniveau vil efterforskere sammenligne effektiviteten af udbyderhenvisninger med brugen af et klinikpatientregister for at identificere kandidater, der kunne drage fordel af en digital mental sundhedsintervention.
Studieoversigt
Status
Tilmelding efter invitation
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Efterforskerne vil evaluere implementeringen af en evidensbaseret, spansk sproglig, digital kognitiv adfærdsterapi (dCBT) intervention (SilverCloud) i sikkerhedsnet-primærplejeklinikker for Latinx-patienter med begrænset engelsk færdighed (LEP) med depression og/eller angst.
Et effektivitetsimplementeringshybridforsøg (Type 2) design med randomisering på både udbyder og patientniveau vil blive udført.
På udbyderniveau vil efterforskerne sammenligne outreach (ved hjælp af klinikpatientregistret) med inreach (traditionel udbyderhenvisning), på patientniveau vil to leveringsformer af dCBT-platformen - understøttet og ikke-understøttet blive sammenlignet.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
426
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Payson, Arizona, Forenede Stater, 85541
- Payson Christian Clinic
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Tucson, Arizona, Forenede Stater, 85711
- Family and Community Medicine Mobile Health Clinic
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California
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Berkeley, California, Forenede Stater, 94720
- University of California
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Irvine, California, Forenede Stater, 92697
- University of California
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San Francisco, California, Forenede Stater, 94110
- Zuckerberg San Francisco General
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San Francisco, California, Forenede Stater, 94114
- Castro-Mission Health Center
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San Francisco, California, Forenede Stater, 94134
- Silver Avenue Family Health Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87017
- UNMH North Valley Clinic
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Albuquerque, New Mexico, Forenede Stater, 87102
- Truman Health Clinic
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Albuquerque, New Mexico, Forenede Stater, 87108
- UNM Southeast Heights Clinic
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Rio Rancho, New Mexico, Forenede Stater, 87144
- Sandoval Regional Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- PHQ-9 ≥ 10 eller GAD-7 ≥ 8
- Har adgang til internettet via smartphone og/eller bredbånd i hjemmet, og grundlæggende niveau af teknologisk færdighed eller vilje til at gennemgå en kort undervisning i teknologibrug
- ≥18 år
- Præference for at modtage lægehjælp på spansk
- Ikke i samtidig psykoterapi
- Hvis patienten i øjeblikket tager antidepressiv medicin, skal patienten have været på en stabil dosis i mindst 6 uger og ikke have planer om at ændre dosis. Vi vil tillade patienter på antidepressiva at deltage i undersøgelsen, da dette vil øge generaliserbarheden. Antidepressiv status vil blive overvåget ved hver vurdering for at kontrollere for disse virkninger, hvis det er nødvendigt.
Ekskluderingskriterier:
- Modtager i øjeblikket psykoterapi, da denne behandling vil blive tilbudt som frontlinjebehandling af depression og angst, men patienter får lov til at blive henvist til behandling mens de deltager i denne undersøgelse, og igangsættelse af behandling vil blive overvåget og overvejet i analyser
- Syns-, høre-, stemme- eller motorisk svækkelse eller analfabetisme, der ville forhindre færdiggørelse af undersøgelsesprocedurer
- Diagnose af en psykotisk lidelse, bipolar lidelse, dissociativ lidelse eller stofbrugsforstyrrelse
- Alvorlig suicidalitet (som vurderet ved at udtrykke selvmordstanker, plan og hensigt). Selvom procedurer med backup-planer er på plads for patienter, der udvikler suicidalitet (se afsnittet om mennesker), vil patienter, der vurderes med alvorlig suicidalitet, blive henvist til mere intensive behandlingsressourcer.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Behandling
Deltagere, der tilfældigt tildeles denne betingelse, vil få alle funktionerne på SilverCloud-platformen samt tildelt en peer-supporter, som vil yde regelmæssig support.
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I den understøttede dCBT-tilstand vil hver patient modtage fuldstændig adgang til SilverCloud-platformen.
Derudover vil patienterne få tildelt en supporter, som vil yde regelmæssig støtte baseret på en etableret coachingstøtteprotokol.
Supportere vil gennemføre et kort engagementsopkald (30-40 minutter) for at give et overblik over SilverCloud, identificere mål og opstille forventninger, præsentere sig selv og orientere deltageren til rollen som peer-supporteren.
Supportere vil derefter sørge for ugentlige check-in via telefonopkald eller beskeder.
Deltagerne vil være i stand til at kommunikere med tilhængerne gennem platformen gennem beskeder eller deleaktiviteter til yderligere diskussion.
Hovedformålet med støtten er at fremme brugen af platformen.
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Aktiv komparator: Styring
Deltagere, der tilfældigt tildeles denne betingelse, vil få alle funktionerne på SilverCloud-platformen med undtagelse af peer-supporteren.
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Ikke-understøttet dCBT giver alle funktioner på SilverCloud-platformen med undtagelse af supportfunktioner (struktureret interaktion med supporter- og delefunktioner).
Patienterne vil få fuldstændig adgang til SilverCloud og instrueret i at bruge det i 8 uger.
Patienter vil modtage ugentlige automatiserede beskeder for at tilskynde til engagement.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ændring i depression efter 8 uger
Tidsramme: Skift fra baseline til uge 8
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Det primære resultat af symptomer på depression vil blive målt med selvrapporten Patient Health Questionnaire-9 (PHQ-9).
PHQ-9 er et 9-elements selvrapporteringsmål for depression.
Score på dette mål går fra 0 (Slet ikke) til 3 (Næsten hver dag).
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Skift fra baseline til uge 8
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Ændring i angst ved 8 uger
Tidsramme: Skift fra baseline til uge 8
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Det primære resultat af symptomer på depression vil blive målt med selvrapporten General Anxiety Disorder-7 (GAD-7).
GAD-7 er et 7-elements selvrapporteringsmål for angst.
Score på dette mål går fra 0 (Slet ikke) til 3 (Næsten hver dag).
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Skift fra baseline til uge 8
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Brug af platform
Tidsramme: Samlet platformbrug fra baseline til uge 8
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Platformbrug vil blive defineret som tid brugt på platformen.
Platformbrug vil variere fra 0 minutter til det højeste antal minutter, nogen deltagere bruger på platformen.
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Samlet platformbrug fra baseline til uge 8
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Ændring i funktion efter 8 uger
Tidsramme: Skift fra baseline til uge 8
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Funktionen vil blive vurderet med World Health Organization Disability Assessment Schedule (WHODAS), en 36 punkters selvrapporteringsmåling, der vurderer handicap på tværs af seks domæner, herunder forståelse og kommunikation, at komme rundt, egenomsorg, omgås mennesker, livsaktiviteter ( husholdning, arbejde og/eller skoleaktiviteter) og deltagelse i samfundet.
Score på dette mål spænder fra 1 (ingen) til 5 (ekstremt).
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Skift fra baseline til uge 8
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ændring i hyppigheden af anvendelse af CBT-baserede færdigheder efter 8 uger
Tidsramme: Skift fra baseline til uge 8
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Frequency of Actions and Thoughts Scale (FATS).
Et 12-element mål, der vil blive brugt til at vurdere, hvor ofte deltagerne anvender CBT-baserede færdigheder.
Højere score betyder, at respondenten har højere frekvens for at anvende de CBT-baserede færdigheder, de har lært.
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Skift fra baseline til uge 8
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Ændring i viden om CBT efter 8 uger
Tidsramme: Skift fra baseline til uge 8
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Videnforøgelse i CBT.
En undersøgelse på 16 punkter, der vil blive brugt til at vurdere ændringer i viden om CBT-terapi.
Højere score betyder, at respondenten har større viden om CBT-færdigheder.
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Skift fra baseline til uge 8
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Ændring i psykologisk velvære
Tidsramme: Skift fra baseline til uge 8
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Psykologisk velvære vil blive vurderet med Brief Inventory of Thriving (BIT), en 10-elements selvrapporteringsmåling.
Score på dette mål spænder fra 5 (lavt niveau af trives) til 50 (højt niveau af trives).
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Skift fra baseline til uge 8
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Ændring i stress efter 8 uger
Tidsramme: Skift fra baseline til uge 8
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Stress vil blive vurderet med Perceived Stress Scale (PSS-4) en 4-punkts selvrapporteringsmål, der vurderer følelser og tanker, som mennesker oplever i forbindelse med deres oplevelse af stress.
Score på dette mål går fra 0 (ingen opfattet stress) til 16 (høj opfattet stress).
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Skift fra baseline til uge 8
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Adrian Aguilera, PhD, University of California, Berkeley
- Ledende efterforsker: Stephen M Schueller, PhD, University of California, Irvine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. marts 2024
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
31. marts 2028
Datoer for studieregistrering
Først indsendt
16. februar 2023
Først indsendt, der opfyldte QC-kriterier
16. februar 2023
Først opslået (Faktiske)
28. februar 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1856
- R01MH126664 (U.S. NIH-bevilling/kontrakt)
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IPD-planbeskrivelse
Individuelle deltagerdata vil blive deponeret i et NIH-datalager NIMH Data Archive
IPD-delingstidsramme
Beskrivende data vil blive indsendt hvert halve år.
Analyserede datasæt om undersøgelsesresultater vil blive deponeret i depotet hurtigst muligt, men senest inden for et år efter projektets afslutning.
Ingen slutdato for datatilgængelighed.
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Enhver, der ønsker at få adgang til dataene og overholder NIMHs dataarkivpolitikker.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ingen
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Kliniske forsøg med Depression, angst
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Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RekrutteringAngst | Angst Depression | Depression Angstlidelse | Depression - svær depressiv lidelseNorge
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Kliniske forsøg med Understøttet dCBT
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Chinese University of Hong KongRekrutteringTeenager | Depression | SøvnløshedHong Kong
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Boston University Charles River CampusAfsluttetAngst | Smerte, kronisk | Smerter, muskuloskeletaleForenede Stater
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