- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06552325
Walk-in terapi i lavbarriere primærpleje
17. august 2026 opdateret af: Lydia Chwastiak, University of Washington
Integration af kort narrativ terapi i lavbarriereklinikker for at forbedre HIV-forebyggelse
Målene for den nuværende forskning er at tilpasse en effektiv walk-in psykoterapi klinikintervention til konteksten af lavbarriere primær pleje; og gennemføre et pilotimplementeringsstudie i to lavbarriere primære klinikker, der er baseret i en samfundsorganisation, der er et drop-in center for mennesker, der oplever hjemløshed i det nordlige Seattle.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Interaktioner mellem de mange helbredstrusler som psykisk sygdom, stofbrug og sociale sårbarheder (hjemløshed, fattigdom) repræsenterer en syndemi, der fastholder hiv-epidemien.
Mental sundhed og misbrugsforstyrrelser har vist sig at øge HIV-risikoadfærd og at have en negativ indvirkning på overholdelse af PrEP.
Udenhusede individer står over for både individuelt niveau (stigma, begrænset social støtte og psykiatriske symptomer) og strukturelt niveau (fattigdom, ustabil bolig, begrænset transport, udgifter til medicinsk behandling) for sundhedspleje.
Walk-in klinikker er designet til at adressere disse barrierer for traditionel primær pleje og give øjeblikkelig adgang til tjenester, når de er nødvendige.
King County WA har finansieret fire primære klinikker med lav barriere siden 2018 som en nøglekomponent i King County EHE-planen.
Data fra disse klinikker tyder på, at ubehandlede psykiske lidelser er en kritisk barriere for engagement i lavbarriere primærpleje.
Integrerede plejemodeller, hvor uddannede specialister i mental sundhed leverer evidensbaseret mental sundhedspleje i primære plejemiljøer, øger adgangen til pleje ved at tilbyde mental sundhedsbehandling, hvor folk allerede søger pleje.
Integreret pleje forbedrer mentale sundhedsresultater, og modeller er gennemførlige at implementere selv i meget begrænsede ressourcer.
Walk-in rådgivningsklinikker i hele provinsen Ontario, Canada, har implementeret en enkelt narrativ terapiintervention for at øge adgangen til mental sundhedspleje.
I denne model bruger terapeuter en enkelt sessions tilgang til at hjælpe klienter med at identificere problemer, genkende og bygge videre på deres styrker og udvikle en handlingsplan.
Narrative tilgange skaber en ikke-patologiserende, kollaborativ og kompetenceorienteret måde at adressere mentale sundhedsbehov.
På grund af uforudsigeligheden af opfølgning i walk-in primærpleje, kan en narrativ tilgang til en enkelt session få mest muligt ud af hver enkelt session, give pragmatiske terapeutiske samtaler til folk, når de har brug for det og støtte mestring, reducere følelsen af isolation og øge følelsen af validering.
Målene for den aktuelle undersøgelse er 1) at udvikle en enkelt session narrativ terapiintervention for at øge adgangen til mental sundhedspleje blandt mennesker, der oplever hjemløshed; og 2) gennemføre et 4-måneders pilotimplementeringsforsøg af den tilpassede intervention i to lavbarriere primære klinikker i det nordlige Seattle.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
64
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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Washington
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Seattle, Washington, Forenede Stater, 98104
- Harborview 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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Patientinkluderingskriterier:
- Vil have gennemført mindst én terapiaftale på [Blindede] klinikkerne
- Evne til at give informeret samtykke
- Evne til at udfylde interviewet eller spørgeskemaet på engelsk
Patientudelukkelseskriterier:
- Manglende evne til at give informeret samtykke
- Behov for akut mental sundhedsbehandling (f.eks. overhængende risiko for skade på sig selv eller andre, akut abstinenser, der kræver medicinsk afgiftning)
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Enkeltsession narrativ terapiintervention
En enkelt narrativ terapisession med en uddannet autoriseret adfærdsmæssig sundhedsudbyder vil blive tilbudt patienter på [Blinded] lavbarriereklinikker.
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Den foreslåede narrative terapiintervention med en enkelt session er blevet implementeret i vid udstrækning i walk-in-terapiklinikker i Ontario-provinsen, Canada.
I disse klinikker er 60-minutters psykoterapisessioner, informeret af narrativ terapi, tilgængelige på walk-in-basis.
Terapeuten samarbejder med en patient for at medudvikle et nyttigt og meningsfuldt fokus for sessionen og involverer derefter patienten i en samtale, der er respektfuld, men som ændrer deres måde at tænke på det præsenterende problem.
Terapeuten fremhæver og dokumenterer patientens værdier og kompetencer og arbejder sammen med patienten om at lave en handleplan.
Hvis terapeuten identificerer yderligere behandlingsbehov, tilbydes patienten en ekstern henvisning til specialiseret psykisk sundhedsvæsen.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number and Representativeness of Participants (Reach)
Tidsramme: at enrollment
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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).
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at enrollment
|
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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.
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1 month
|
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Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score (Effectiveness)
Tidsramme: 1 month
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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.
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1 month
|
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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.
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1 month
|
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Psychological Well-being Measured by World Health Organization-Five Well-Being Index (WHO-5) Score (Effectiveness)
Tidsramme: 1 month
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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.
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1 month
|
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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
|
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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
|
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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.
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1 month
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Understanding of Problem Item From Brief Services Evaluation (Effectiveness)
Tidsramme: 1 month
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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.
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1 month
|
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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
|
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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
|
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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
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1 month
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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.
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during SSNT session
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Acceptability Measured by Single Session Impression and Feedback Tool (SSIFT) (Implementation)
Tidsramme: immediately post-session
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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.
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immediately post-session
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Acceptability Measured by Acceptability of Intervention Measure (AIM) (Implementation)
Tidsramme: 1 month
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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.
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1 month
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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: Lydia Chwastiak, University of Washington
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)
3. oktober 2024
Primær færdiggørelse (Faktiske)
10. april 2025
Studieafslutning (Faktiske)
10. april 2025
Datoer for studieregistrering
Først indsendt
10. august 2024
Først indsendt, der opfyldte QC-kriterier
10. august 2024
Først opslået (Faktiske)
14. august 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. august 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Blodbårne infektioner
- Urogenitale sygdomme
- Genitale sygdomme
- Psykiske lidelser
- Sygdomme i immunsystemet
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Kemisk inducerede lidelser
- Langsomme virussygdomme
- HIV-infektioner
- Stof-relaterede lidelser
- Erhvervet immundefektsyndrom
Andre undersøgelses-id-numre
- STUDY00018557
- 3P30MH123248-03 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Forskerpersonens afidentificerede data vil blive delt gennem National Institute of Mental Health Data Archive (NDA).
IPD-delingstidsramme
Data vil blive gjort tilgængelige i overensstemmelse med den første dataindsendelsesdato, der kræves af National Institute of Mental Health Data Archive.
IPD-delingsadgangskriterier
Oversigtsoplysninger om de data, der deles i NDA, er tilgængelige i NDA-forespørgselsværktøjet uden behov for en NDA-brugerkonto.
For at anmode om adgang til persondata på rekordniveau skal der indsendes en anmodning om dataadgang.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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