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Walk-in terapi i lavbarriere primærhelsetjenesten

17. august 2026 oppdatert av: Lydia Chwastiak, University of Washington

Integrering av kort narrativ terapi i lavbarriereklinikker for å forbedre HIV-forebygging

Målene med den nåværende forskningen er å tilpasse en effektiv walk-in psykoterapi klinikk intervensjon for konteksten av lavbarriere primæromsorg; og gjennomføre en pilotimplementeringsstudie i to lavbarriere primærhelseklinikker som er basert i en samfunnsorganisasjon som er et drop-in-senter for mennesker som opplever hjemløshet i North Seattle.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Interaksjoner mellom de mange helsetruslene psykiske lidelser, rusmiddelbruk og sosiale sårbarheter (hjemløshet, fattigdom) representerer en syndemi som opprettholder HIV-epidemien. Psykisk helse og rusforstyrrelser har vist seg å øke HIV-risikoatferd og å ha en negativ innvirkning på overholdelse av PrEP. Personer uten hus møter både individnivå (stigma, begrenset sosial støtte og psykiatriske symptomer) og strukturelt nivå (fattigdom, ustabil bolig, begrenset transport, kostnader for medisinsk behandling) for helsetjenester. Inngangsklinikker er utformet for å adressere disse barrierene for tradisjonell primærhelse og gi umiddelbar tilgang til tjenester når de trengs. King County WA har finansiert fire lavbarriere primærhelseklinikker siden 2018 som en nøkkelkomponent i King County EHE-planen. Data fra disse klinikkene tyder på at ubehandlede psykiske lidelser er en kritisk barriere for engasjement i lavbarriere primærhelsetjenesten. Integrerte omsorgsmodeller der utdannede spesialister innen psykisk helse leverer evidensbasert psykisk helsehjelp i primærhelsetjenesten øker tilgangen til omsorg ved å tilby psykisk helsebehandling der folk allerede søker omsorg. Integrert omsorg forbedrer mentale helseutfall, og modeller er gjennomførbare å implementere selv i svært lite ressursmiljøer. Rådgivende klinikker i hele provinsen Ontario, Canada, har implementert en enkelt narrativ terapiintervensjon for å øke tilgangen til psykisk helsehjelp. I denne modellen bruker terapeuter en enkeltsesjonstilnærming for å hjelpe klienter med å identifisere problemer, gjenkjenne og bygge videre på deres styrker og utvikle en handlingsplan. Narrative tilnærminger skaper en ikke-patologiserende, samarbeidende og kompetanseorientert måte å møte psykiske helsebehov. Gitt uforutsigbarheten av oppfølging i walk-in primærhelsetjenesten, kan en enkeltsesjons narrativ tilnærming få mest mulig ut av hver enkelt økt, gi pragmatiske terapeutiske samtaler til folk når de trenger det og støtte mestring, redusere følelsen av isolasjon og øke sansen. av validering. Målene for den nåværende studien er 1) å utvikle en enkelt-sesjon narrativ terapiintervensjon for å øke tilgangen til psykisk helsehjelp blant mennesker som opplever hjemløshet; og 2) gjennomføre en 4-måneders pilotimplementeringsforsøk av den tilpassede intervensjonen i to lavbarriere primærhelseklinikker i Nord-Seattle.

Studietype

Intervensjonell

Registrering (Faktiske)

64

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Harborview Medical Center

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Pasientinkluderingskriterier:

  • Vil ha gjennomført minst én terapitime ved [Blindede]-klinikkene
  • Evne til å gi informert samtykke
  • Evne til å fullføre intervjuet eller spørreskjemaet på engelsk

Pasientekskluderingskriterier:

  • Manglende evne til å gi informert samtykke
  • Behov for akutt psykisk helsebehandling (f.eks. overhengende risiko for skade på seg selv eller andre, akutt abstinens som krever medisinsk avgiftning)

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Enkelt økt narrativ terapiintervensjon
En enkelt narrativ terapiøkt med en utdannet lisensiert atferdshelseleverandør vil bli tilbudt pasienter ved [Blinded] lavbarriereklinikker.
Atferdsmessig: Enkelt økt narrativ terapi
Den foreslåtte enkeltsesjons narrative terapiintervensjonen har blitt implementert bredt i terapiklinikker i Ontario-provinsen, Canada. I disse klinikkene er 60-minutters psykoterapiøkter, informert av narrativ terapi, tilgjengelig på walk-in-basis. Terapeuten samarbeider med en pasient for å utvikle et nyttig og meningsfullt fokus for økten, og deretter engasjere pasienten i en samtale som er respektfull, men som endrer deres måte å tenke på det presenterende problemet. Terapeuten fremhever og dokumenterer pasientens verdier og ferdigheter og jobber sammen med pasienten for å lage en handlingsplan. Dersom terapeuten identifiserer ytterligere behandlingsbehov, tilbys pasienten ekstern henvisning til spesialisert psykisk helsevern.
Andre navn:
  • Kort narrativ terapi

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number and Representativeness of Participants (Reach)
Tidsramme: at enrollment
Number of patients who participated in research and had ≥1 session with the therapist; Representativeness of patients (with respect to age, gender, race/ethnicity, living situation, employment, insurance, education) who had ≥1 session with the therapist (compared to full clinic population).
at enrollment
Number of Participants That Completed Interviews by Interview Type (Reach, Effectiveness and Implementation)
Tidsramme: 1 month
Staff, therapist and pilot participant in-depth interviews were conducted post-implementation by research team members. They explored stakeholder perspectives on who was not reached, why they were not reached and opportunities for improvement (Reach); SSNT impact on clients (Effectiveness); acceptability and appropriateness of the intervention, and determinants of implementation (Implementation). After interviews were collected, we used rapid deductive qualitative analysis to assess these outcomes, and generated a table with key findings.
1 month
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score (Effectiveness)
Tidsramme: 1 month
The PHQ-8 is a validated measure of depression symptom severity over the previous two weeks. The total score ranges from 0-24 with higher scores reflecting more severe symptoms; a cut-off score of 10 has high sensitivity and specificity for clinically significant depressive symptoms. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.
1 month
Anxiety Symptoms Measured by Generalized Anxiety Disorder 7-item (GAD-7) Score (Effectiveness)
Tidsramme: 1 month
The GAD-7 is a validated measure of anxiety symptom severity over the previous two weeks. The total score ranges from 0-21 with higher score reflecting more severe symptoms; a cut-off score of 10 has good sensitivity and specificity for a diagnosis of generalized anxiety disorder. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.
1 month
Psychological Well-being Measured by World Health Organization-Five Well-Being Index (WHO-5) Score (Effectiveness)
Tidsramme: 1 month
The WHO-5 is a validated measure of psychological well-being that asks how often someone felt cheerful, calm, active, fresh, and interested in life over the last two weeks. Total score range is 0-25, with a higher score indicating greater well-being. A score below 13 suggests the need to screen for depression. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.
1 month
Individual's Resilience Measured by Trait Resilience From the State-Trait Assessment of Resilience Scale (STARS) (Effectiveness)
Tidsramme: 1 month
Trait Resilience from STARS assesses an individual's resilience within a variety of demanding contexts. The 7-item questionnaire has a 4-point Likert scale response range of "Disagree" to "Strongly Agree;" total score ranges from 7-28, with higher scores reflecting greater resilience. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.
1 month
Social Connectedness Measured by The Social Connectedness Scale (Effectiveness)
Tidsramme: 1 month
The Social Connectedness Scale is a reliable and valid 6-item self-report measure based on Kohut's self-psychology theory. Total scores range from 6-36, with higher scores reflecting a greater sense of social connectedness. Validation studies have shown good internal reliability and test stability over two-week period. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.
1 month
General Health Measured by General Health Domain From the 36-Item Medical Outcomes Study Short Form Survey (SF-36) (Effectiveness)
Tidsramme: 1 month
The single-item General Health domain from the 36-Item Medical Outcomes Study Short Form Survey (SF-36) asks "In general, would you say your health is:" and has a five-point Likert scale response range from Excellent (1) to Poor (5). This single item has been validated as an indicator of health perception, differentiating between healthy and ill groups, and is reliable and valid across diverse populations, including people experiencing homelessness. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.
1 month
Understanding of Problem Item From Brief Services Evaluation (Effectiveness)
Tidsramme: 1 month
The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.
1 month
Possession of Skills Needed to Solve Problem Item From Brief Services Evaluation (Effectiveness)
Tidsramme: 1 month
The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.
1 month
Awareness of Strengths Item From Brief Services Evaluation (Effectiveness)
Tidsramme: 1 month
The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.
1 month
Ideas About How to Solve Problem Item From Brief Services Evaluation (Effectiveness)
Tidsramme: 1 month
The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.
1 month
Knowledge About Social Supports to Help Item From Brief Services Evaluation (Effectiveness)
Tidsramme: 1 month
The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.
1 month
Knowledge About Community Resources to Help Item From Brief Services Evaluation (Effectiveness)
Tidsramme: 1 month
The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.
1 month
Service Utilization (Implementation)
Tidsramme: 1 month
Service utilization was measured as the number of SSNT sessions received by each neighbor
1 month
Fidelity to SSNT (Implementation)
Tidsramme: during SSNT session
Therapists' session notes were analyzed for the presence of two fidelity indicators: whether the note indicated that the session had a beginning, middle, and end, and whether narrative therapy skills were used.
during SSNT session
Acceptability Measured by Single Session Impression and Feedback Tool (SSIFT) (Implementation)
Tidsramme: immediately post-session
The Single Session Impression and Feedback Tool (SSIFT) is considered as an indicator of acceptability. Developed for walk-in clinics implementing SSNT, it includes eight items on a 7-point scale (range 1-7) that invite feedback from participants on their perception of the process and outcome of the SSNT intervention. Six items focus on how collaborative the service was, one on the degree of hope the conversation engendered, and one on the conversation's usefulness. We report the mean across the eight items, and higher scores indicate more favorable impressions of the SSNT intervention. As the SSIFT was designed as a therapist feedback tool, its psychometric properties have not been reported. This evaluation was completed by pilot participants immediately after their first SSNT session.
immediately post-session
Acceptability Measured by Acceptability of Intervention Measure (AIM) (Implementation)
Tidsramme: 1 month
The Acceptability of Intervention Measure (AIM) is a valid and reliable 4-item patient-reported outcome measure that measures the acceptability of an intervention. Responses to items are a 5-point Likert scale from Completely Disagree (1) to Completely Agree (5). We report the mean across the 4 items, and a higher score indicates greater intervention acceptability (range 1-5). The AIM was completed 1-month after pilot participants' first SSNT session.
1 month

Samarbeidspartnere og etterforskere

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

Sponsor

University of Washington

Samarbeidspartnere

National Institute of Mental Health (NIMH)

Etterforskere

  • Hovedetterforsker: Lydia Chwastiak, University of Washington

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 (Faktiske)

3. oktober 2024

Primær fullføring (Faktiske)

10. april 2025

Studiet fullført (Faktiske)

10. april 2025

Datoer for studieregistrering

Først innsendt

10. august 2024

Først innsendt som oppfylte QC-kriteriene

10. august 2024

Først lagt ut (Faktiske)

14. august 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00018557
  • 3P30MH123248-03 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Forskerpersonens avidentifiserte data vil bli delt gjennom National Institute of Mental Health Data Archive (NDA).

IPD-delingstidsramme

Data vil gjøres tilgjengelig i samsvar med den første datainnleveringsdatoen som kreves av National Institute of Mental Health Data Archive.

Tilgangskriterier for IPD-deling

Sammendragsinformasjon om dataene som deles i NDA, er tilgjengelig i NDA Query Tool uten behov for en NDA-brukerkonto. For å be om tilgang til persondata på rekordnivå, må en forespørsel om datatilgang sendes inn.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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