ASHA Bangladesh – Integrerad intervention för att bekämpa fattigdom och depression
1 maj 2024 uppdaterad av: Alison Karasz, University of Massachusetts, Worcester
ASHA Bangladesh - En integrerad intervention för att bekämpa depression hos låginkomstkvinnor på landsbygden
Målet med denna randomiserade kontrollerade studie är att jämföra effekten av en integrerad intervention som kombinerar fattigdomsbekämpning och depressionsbehandling med enbart depressionsbehandling, hos låginkomstkvinnor på landsbygden i Bangladesh med depression.
Huvudfrågorna som den syftar till att besvara är: 1) huruvida att lägga till fattigdomsbekämpning till depressionsbehandling i en integrerad intervention förbättrar depressionsresultaten vid 24 månader, bedömda av depressiva symtom och av närvaron eller frånvaron av återfall; och 2) huruvida tillförsel av fattigdomsbekämpning till depressionsbehandling förbättrar genomföranderesultaten inklusive behandlingsupptagning och retention.
Deltagare i båda armarna kommer att delta i intervjuer vid 6,12,18 och 24 månader.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
660
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Alison Karasz, PhD
- Telefonnummer: 3478435652
- E-post: alison.karasz@umassmed.edu
Studieorter
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Dhaka, Bangladesh
- Rekrytering
- International Centre for Diarrhoeal Disease Research
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Kontakt:
- Fahmida Tofail, MBBS, PhD
- E-post: ftofail@icddrb.org
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inklusionskriterier:
- gifta kvinnor;
- ålder 18-75;
- flytande bengali);
- Uppfyller kriterier på ett ekonomiskt sårbarhetsindex
- >=10 på Patient Health Questionnaire (PHQ-9 Depression Scale vid baslinjen
Exklusions kriterier:
- Oförmåga att ge informerat samtycke;
- Planerar att resa i > 1 månad under 24 M period.
- Oförmåga att delta i studien av någon annan anledning
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Depressionsbehandling (DT)
Deltagarna i kontrollgruppen kommer att få en 6 månaders manuell gruppbaserad psykoterapibehandling.
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Manuell gruppbaserad psykoterapi.
Denna intervention är anpassad från Världshälsoorganisationens (WHO) Problem Management Plus (PM+) intervention, och inkluderar beteendeaktivering, förbättrat socialt stöd och problemhantering.
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Experimentell: Integrerad intervention
Den experimentella armen innehåller 2 element:
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Denna intervention inkluderar tillgångsöverföring, kompetensöverföring, utbildning i finansiell läskunnighet, stipendium, sparkonton, veterinärstöd, foder och jordbruksutbildning
Manuell gruppbaserad psykoterapi.
Denna intervention är anpassad från Världshälsoorganisationens (WHO) Problem Management Plus (PM+) intervention, och inkluderar beteendeaktivering, förbättrat socialt stöd och problemhantering.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Förändring av depressiva symtom vid 24 månader
Tidsram: 24 månader
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Förändring i symtom från baslinjen till 24 månader efter baslinjen, mätt med Patient Health Questionnaire, ett frågeformulär med 9 artiklar utformat för att bedöma depressiva symtom.
Minsta poäng är 0; maxpoängen är 27.
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24 månader
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Förändring av depressiva symtom vid mellanliggande tidpunkter
Tidsram: 6, 12, 18 månader
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Förändring i symtom från baslinjen till 6, 12 och 18 månader efter baslinjen, mätt med Patient Health Questionnaire, ett frågeformulär med 9 punkter utformat för att bedöma depressiva symtom.
Minsta poäng är 0; maxpoängen är 27.
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6, 12, 18 månader
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24 månaders återfall
Tidsram: 24 månader
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Återfall definieras som en poäng av patienthälsans frågeformulär>= 10 bland deltagare som uppnådde remission vid 6 månader.
För att bedöma återfall kommer utredarna att fråga deltagarna om upplevelsen av depressiva symtom när som helst sedan den tidigare datainsamlingspunkten.
Datainsamlingen kommer att fokusera på 24 månaders återfall, eller förekomsten av återfall när som helst sedan tid 2 (6 månader).
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24 månader
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Ekonomisk sårbarhet
Tidsram: Baslinje, 12 och 24 månader
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Ett sammansatt index för ekonomisk sårbarhet som inkluderar inkomster, tillgångar, skulder, matosäkerhet, ekonomisk oro.
Detta mått har ingen fast poäng utan är sammansatt med ett pragmatiskt tillvägagångssätt baserat på data som samlats in på fältet.
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Baslinje, 12 och 24 månader
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Ångest
Tidsram: Baslinje, 6 månader, 12 månader och 24 månader
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Ångestsymtom mätt på skalan för allmänna ångeststörningar - ett frågeformulär med sju punkter med poäng från 0-231.
Högre poäng tyder på mer ångest.
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Baslinje, 6 månader, 12 månader och 24 månader
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Fungera
Tidsram: Baslinje, 6 månader, 12 månader och 24 månader
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Funktion och funktionshinder mätt av Världshälsoorganisationen Disability Assessment Schedule, ett frågeformulär med 12 punkter som får poäng från 12-60 med högre poäng som indikerar större funktionshinder.
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Baslinje, 6 månader, 12 månader och 24 månader
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Spänningsskala
Tidsram: Baslinje, 6 månader, 12 månader, 18 månader och 24 månader
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Ett frågeformulär som mäter både psykologiska symtom och somatiska kulturella symtom: ett instrument med 39 objekt mätt från 0-3 med ett minimumpoäng på 0 och ett maximalt betyg på 117. med högre poäng som indikerar högre nivåer av nöd.
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Baslinje, 6 månader, 12 månader, 18 månader och 24 månader
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Europeisk livskvalitet Fem dimensioner Fem nivåskala
Tidsram: Baslinje, 6 månader, 12 månader och 24 månader
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Livskvalitetsmått som inkluderar fem dimensioner: rörlighet, egenvård, vanliga aktiviteter, smärta/obehag och ångest/depression, poängsatt från 0-100 med högre poäng som indikerar bättre livskvalitet.
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Baslinje, 6 månader, 12 månader och 24 månader
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Implementeringsresultat - Adoption
Tidsram: Baslinje + 30 dagar
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Antalet deltagare som deltar i >-1 behandlingstillfälle/# deltagare randomiserat.
Baserat på rekrytering och studiejournaler.
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Baslinje + 30 dagar
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Implementeringsresultat - Genomförbarhet
Tidsram: Sex månader
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Procent av deltagarna som deltar >= 75 procent av interventionssessionerna - baserat på studieregister
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Sex månader
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Implementeringsresultat - trohet
Tidsram: Insatsmånad 1, 3 och 6
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Handledarens observationer av sessioner kommer att bedömas för trohet med hjälp av en LIKERT-skala som inkluderar beredskap (0-3), Facilitering (0-11), Engagemang (0-6) tidshantering (0-1) och Dokumentation (0-1).
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Insatsmånad 1, 3 och 6
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Alison Karasz, PhD, UMass Chan Medical School
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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Gerbera Therapeutics, Inc.Har inte rekryterat ännuPostpartum depression | Depression, postpartum | Postnatal depression | Post-partum depression | Post-Natal depressionFörenta staterna
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Northern Illinois UniversityUniversity Autonoma de Santo DomingoAvslutadDepression Måttlig | Depression MildFörenta staterna, Dominikanska republiken
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Charite University, Berlin, GermanyAvslutadBehandling Resistent depression | Depression, unipolär | Depression KroniskTyskland