Walk-in terapie v primární péči s nízkou bariérou
Integrace krátké narativní terapie na klinikách s nízkými bariérami za účelem posílení prevence HIV
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Lydia Chwastiak
- Telefonní číslo: 206-744-4840
- E-mail: lchwast@uw.edu
Studijní místa
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Washington
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Seattle, Washington, Spojené státy, 98104
- Harborview Medical Center
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Kritéria pro zařazení pacienta:
- Absolvuje alespoň jednu terapeutickou schůzku na [Blinded] klinikách
- Schopnost poskytnout informovaný souhlas
- Schopnost vyplnit pohovor nebo dotazník v angličtině
Kritéria pro vyloučení pacienta:
- Neschopnost poskytnout informovaný souhlas
- Potřeba urgentní léčby duševního zdraví (např. bezprostřední riziko poškození sebe sama nebo druhých, akutní vysazení vyžadující lékařskou detoxikaci)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: Jedno sezení narativní terapie intervence
Pacientům na nízkobariérových klinikách [Blinded] bude nabídnuto jediné sezení narativní terapie s vyškoleným licencovaným poskytovatelem behaviorální zdravotní péče.
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Navrhovaná intervence narativní terapie s jedním sezením byla široce implementována na klinikách s vlastní léčbou v provincii Ontario v Kanadě.
V těchto klinikách jsou k dispozici 60minutové psychoterapeutické sezení, které je založeno na narativní terapii.
Terapeut spolupracuje s pacientem na společném rozvoji užitečného a smysluplného zaměření pro sezení a poté zapojí pacienta do rozhovoru, který je respektující, ale posouvá jeho způsob uvažování o aktuálním problému.
Terapeut vyzdvihuje a dokumentuje pacientovy hodnoty a dovednosti a spolupracuje s pacientem na vytvoření akčního plánu.
Pokud terapeut identifikuje další potřeby léčby, je pacientovi nabídnuto externí doporučení ke speciálním službám duševního zdraví.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number and Representativeness of Participants (Reach)
Časové okno: 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)
Časové okno: 1 month
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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)
Časové okno: 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)
Časové okno: 1 month
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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)
Časové okno: 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)
Časové okno: 1 month
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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.
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1 month
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Social Connectedness Measured by The Social Connectedness Scale (Effectiveness)
Časové okno: 1 month
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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.
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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)
Časové okno: 1 month
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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)
Časové okno: 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)
Časové okno: 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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Awareness of Strengths Item From Brief Services Evaluation (Effectiveness)
Časové okno: 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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Ideas About How to Solve Problem Item From Brief Services Evaluation (Effectiveness)
Časové okno: 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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Knowledge About Social Supports to Help Item From Brief Services Evaluation (Effectiveness)
Časové okno: 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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Knowledge About Community Resources to Help Item From Brief Services Evaluation (Effectiveness)
Časové okno: 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.
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1 month
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Service Utilization (Implementation)
Časové okno: 1 month
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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)
Časové okno: during SSNT session
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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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Lydia Chwastiak, University of Washington
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Infekce přenášené krví
- Urogenitální onemocnění
- Onemocnění genitálií
- Duševní poruchy
- Onemocnění imunitního systému
- Infekce
- RNA virové infekce
- Virová onemocnění
- Přenosné nemoci
- Pohlavně přenosné choroby, virové
- Pohlavně přenosné nemoci
- Lentivirové infekce
- Retroviridae infekce
- Syndromy imunologické nedostatečnosti
- Chemicky indukované poruchy
- Pomalá virová onemocnění
- HIV infekce
- Poruchy související s látkami
- Syndrom získané immunití nedostatečnisti
Další identifikační čísla studie
Další identifikační čísla studie
- STUDY00018557
- 3P30MH123248-03 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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