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Virkningen af ​​VVV-gruppen for veteraner med SMI (VVV)

28. april 2026 opdateret af: VA Office of Research and Development

Virkning af veteranstemmer og -visioner Peer Support Groups på social integration for veteraner med SMI/psykose

Veteraner med alvorlig psykisk sygdom (SMI) kæmper med social integration - deltagelse i arbejde, bolig og medborgerskab - på grund af symptomer, stigmatisering og psykosociale udfordringer. På trods af betydelige VA-bestræbelser på at yde mental sundhedspleje til veteraner med SMI, mangler der programmer, der fremmer social integration. Veteraner med SMI er i særlig høj risiko for dårlig social integration og selvmordstanker under COVID-19-pandemien. Dette projekt løser dette behov med en gruppebaseret, peer specialist (PS) co-faciliteret psykosocial intervention for veteraner med SMI, kaldet "Veteran Voices and Visions" (VVV). VVV henvender sig til veteraner med SMI, der oplever psykose, en gruppe, der især har behov for støtte til social integration. Virtuelle VVV-grupper ledes i fællesskab af VA mentale sundhedsklinikere (MHC'er) og PS'er via online videokonference. Tilgangen letter gruppesamhørighed omkring og normalisering af de almindelige psykotiske symptomer på SMI: hallucinationer, vrangforestillinger og social isolation. Denne intervention har potentialet til at skabe og fremme et støttende fællesskab, der forbedrer deltagernes sociale integration ved at reducere deres nød og selvstigmatisering og øge deres selveffektivitet.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a single arm study of feasibility and acceptability of the adapted manual and protocol we have developed in preparation for a larger efficacy trial.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • West Los Angeles, California, Forenede Stater, 90073-1003
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

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:

  • DSM 5 diagnoser af skizofreni, skizoaffektiv lidelse, bipolar med psykose, depression med psykose, uspecificeret psykose

Ekskluderingskriterier:

  • Stof-induceret psykose,
  • klinisk signifikant neurologisk sygdom,
  • anamnese med alvorlig hovedskade med tab af bevidsthed > 1 time.

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
Eksperimentel: Veteran Voices & Visions (VVV)
Veteran Voices and Visions is the experimental condition. It is a group of Veterans who are experiencing chronic psychosis. The group meets for 60 minutes, weekly, for 12 weeks. The investigators adapted a manual and protocol for the VA and this study is testing this manual. This is a single-arm study.
Adfærdsmæssigt: Veteran Voices and Visions
Clinician and peer co-led meaning-oriented support group based on the Hearing Voices approach.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Psychotic Symptoms Rating Scale (PSYRATS-AH)
Tidsramme: 12 weeks after the initiation of the intervention
PSYRATS-AH is an 11-item scale which assesses the frequency, duration, severity, loudness, location, negative content, and controllability of voices, intensity of distress, and beliefs about origin of voices and disruptiveness. Minimum score is 0, maximum 44. Any decrease in overall score is indicative of decreased distress.
12 weeks after the initiation of the intervention
Role Functioning Scale Total Score
Tidsramme: 12 weeks after the initiation of the intervention
The Role Functioning Scale (RFS) is a broad global integration index across the 4 domains: work, independent living, and family relationships and immediate social network relationships. Each domain ranges from 1 (worst) to 7 (best), for a total score range of minimum 4, maximum 28.
12 weeks after the initiation of the intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Beliefs About Voices Questionnaire-R Omnipotence Subscale
Tidsramme: 12 weeks
The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The omnipotence subscale measures the amount of omnipotence the subjects attributes to their voice. Minimum score is 0, maximum is 18, higher score indicates greater omnipotence.
12 weeks
Beliefs About Voices Questionnaire-R Malevolence Subscale
Tidsramme: 12 weeks
The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The malevolence subscale measures the amount of malevolence the subjects attribute to their voice. Minimum score is 0, maximum is 18, higher score indicates greater malevolence.
12 weeks
Beliefs About Voices Questionnaire-R Benevolence Subscale
Tidsramme: 12 weeks
The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The benevolence subscale measures the amount of benevolence the subjects attribute to their voice. Minimum score is 0, maximum is 18, higher score indicates greater benevolence.
12 weeks
Beliefs About Voices Questionnaire-R Resistance Subscale
Tidsramme: 12 weeks
The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The resistance subscale measures the degree to which the subject willingly engages with their voices. Minimum score is 0, maximum is 18, higher score indicates greater resistance and less engagement.
12 weeks
Beliefs About Voices Questionnaire-R Emotional Resistance Subscale
Tidsramme: 12 weeks
The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The emotional resistance subscale measures the degree to which the subject willingly engages with their voices emotionally. Minimum score is 0, maximum 12, higher score indicates greater resistance and less engagement.
12 weeks
Beliefs About Voices Questionnaire-R Behavioral Resistance Subscale
Tidsramme: 12 weeks
The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The behavioral resistance subscale measures the degree to which the subject willingly engages with their voices behaviorally. Minimum score is 0, maximum is 15, higher score indicates greater resistance and less engagement.
12 weeks
Beliefs About Voices Questionnaire-R Engagement Subscale
Tidsramme: 12 weeks
The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The engagement subscale measures the degree to which the subject willingly engages with their voices. Minimum score is 0, maximum 27, higher score indicates greater engagement.
12 weeks
Beliefs About Voices Questionnaire - R Emotional Engagement Subscale
Tidsramme: 12 weeks
The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The emotional engagement subscale measures the degree to which the subject willingly engages with their voices emotionally. Minimum score is 0, maximum 15, higher score indicates greater engagement.
12 weeks
Beliefs About Voices Questionnaire - R Behavioral Engagement Subscale
Tidsramme: 12 weeks
The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The behavioral engagement subscale measures the degree to which the subject willingly engages with their voices behaviorally. Minimum score is 0, maximum is 12, Higher score indicates greater engagement.
12 weeks
Peters Delusion Inventory Count
Tidsramme: 12 weeks
The Peters Delusion Inventory is a 21-item measure of distress, preoccupation, and conviction of delusions with high convergent, discriminant, and criterion validity. Minimum score is 0, maximum is 21. Higher score indicates worse outcome.
12 weeks
Peters Delusion Inventory Distress Subscale
Tidsramme: 12 weeks
The Peters Delusion Inventory is a 21-item measure of distress, preoccupation, and conviction of delusions with high convergent, discriminant, and criterion validity. Minimum score is 0, maximum is 60. Higher score indicates worse outcome. The distress subscale measures the amount of cumulative distress associated with all reported delusions.
12 weeks
Brief Psychiatric Rating Scale Global Score
Tidsramme: 12 weeks
Assesses for psychiatric symptoms-specifically the positive/negative symptom assess subscale scores and suicidal ideation. Minimum score is 24, maximum is 168. Higher score indicates worse outcome.
12 weeks
Questionnaire on the Process of Recovery
Tidsramme: 12 weeks
The Questionnaire on the Process of Recovery (QPR) is an instrument co-developed by service users and re-searchers about recovery from psychosis with 15 items measuring connectedness, hope, identity, meaning, and empowerment. The QPR has demonstrated high internal and convergent validity as well as sensitivity to change. Minimum score is 0, maximum is 60. Higher score indicates better outcome.
12 weeks
Generalized Self-Efficacy Scale
Tidsramme: 12 weeks
Generalized Self-Efficacy Scale is a 10-item measure of self-efficacy that has been shown to be valid and reliable and has been used with schizophrenia. Range, 10-40. Higher score indicates better outcome.
12 weeks
Internalized Stigma of Mental Illness
Tidsramme: 12 weeks
The Internalized Stigma of Mental Illness scale is a 29-item measure of internalized stigma with five subscales (alienation, stereotype endorsement, discrimination, experience, social withdrawal, and stigma resistance). It has been used with schizophrenia and is reliable (a = .90) and valid. Range, 1-4, as all item scores are averaged. Higher score indicates worse outcome.
12 weeks
UCLA Loneliness Scale
Tidsramme: 12 weeks
UCLA Loneliness Scale, a 20-item scale measuring subjective experience of loneliness, is considered the gold standard measure of perceived social isolation and is highly reliable (a = .89-.94) and valid. It has been used with SSD. Range, 20-80. Higher score indicates worse outcome.
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

VA Office of Research and Development

Efterforskere

  • Ledende efterforsker: Ippolytos A Kalofonos, MD PhD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

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)

18. marts 2024

Primær færdiggørelse (Faktiske)

1. marts 2025

Studieafslutning (Faktiske)

1. marts 2025

Datoer for studieregistrering

Først indsendt

27. september 2022

Først indsendt, der opfyldte QC-kriterier

27. september 2022

Først opslået (Faktiske)

3. oktober 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D4376-P

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

PI'en vil skabe afidentificerede, undersøgelsesspecifikke datasæt, der inkluderer alle variabler i en publikation. Noget tab af information kan forekomme i betragtning af behovet for at fjerne PHI. PI'en vil erstatte person- og lægestationsnumre med studiespecifikke numre. PI vil droppe fødselsdatoen og erstatte alder med alderskategorier i overensstemmelse med PHI-kravene for personer 85 år og ældre. Datoer for service vil blive erstattet med årgangsdukker.

IPD-delingstidsramme

Datasæt, der opfylder VA-standarderne for offentliggørelse, vil blive gjort tilgængelige inden for 1 år efter offentliggørelsen.

IPD-delingsadgangskriterier

Inden distributionen vil en lokal privatlivsansvarlig bekræfte, at alle datasæt ikke indeholder nogen PHI. Endelige datasæt vil blive vedligeholdt lokalt, indtil ressourcer på virksomhedsniveau bliver tilgængelige for langtidslagring og adgang. Vejledning om forespørgsel og distributionsprocesser vil blive leveret af ORD. De, der anmoder om data, vil blive bedt om at underskrive en aftale.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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