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Et Pilot-deltagelsesprogram Evaluering af et virtuelt traumestøtteprogram for autistiske voksne

5. juni 2026 opdateret af: University of Wyoming

Effekten af ​​en posttraumatisk stresslidelse (PTSD) intervention for autistiske voksne på bioadfærdsmæssig sundhed

Målet med dette enkelt-gruppe kliniske forsøg er at lære om den indledende effektivitet og gennemførlighed af telehealth-leveret Written Exposure Therapy (WET) til autistiske voksne med traumatiske stresssymptomer. De vigtigste spørgsmål, efterforskerne forsøger at besvare, er:

  • Falder symptomerne på posttraumatisk stresslidelse (PTSD) og samtidige mentale sundhedsproblemer efter at have modtaget WET?
  • Forbedres bioadfærdsmæssige sundhedsresultater, herunder objektive (Fitbit-indikatorer for aktivitet, søvn og hjertefrekvens) og subjektivt rapporterede sundhedsvariabler (f.eks. søvn, smerte, sundhedsrelateret livskvalitet), efter at have modtaget WET?
  • Hvordan oplever autistiske voksne WET, og hvordan kan dette program modificeres og forbedres i fremtiden i samarbejde med autistiske voksne?

Deltagerne vil gennemføre følgende som en del af undersøgelsen, som fuldføres udelukkende over telesundhed.

  • Deltagerne vil først gennemføre en indledende vurdering, der involverer korte målinger af kognition og autistiske træk, samt interviews og spørgeskemaer om PTSD, mental sundhed og fysisk sundhed. Hvis de er kvalificerede, vil deltagerne fortsætte til følgende trin:
  • Kvalificerede deltagere vil derefter begynde at bære en Fitbit, som skal bruges under undersøgelsens varighed.
  • Deltagerne vil derefter deltage i 5 ugentlige virtuelle besøg, der involverer WET-protokollen, inklusive ugentlig kort vurdering af PTSD og mental og fysisk sundhed.
  • Derefter vil deltagerne gennemføre et sjette virtuelt besøg den følgende uge, hvor PTSD, mental og fysisk sundhed og behandlingsfeedback vurderes.
  • Endelig vil deltagerne gennemføre virtuelle besøg 1 og 6 måneder senere, der involverer revurdering af PTSD og mental og fysisk sundhed.

Derfor er dette et pre-post single group design, hvor alle deltagere vil modtage WET for at etablere initial effektivitet og gennemførlighed. Undersøgere vil også rådføre sig med et autistisk rådgivende udvalg under hele projektet og foretage tilpasninger som anbefalet i samråd med autistiske voksne. Målet er bedre at forstå den indledende effekt og gennemførlighed af WET til at støtte autistiske voksne, der har oplevet traumer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

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
    • Wyoming
      • Laramie, Wyoming, Forenede Stater, 82071
        • University of Wyoming

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

Ingen

Beskrivelse

Inklusionskriterier:

  • Autistisk
  • Alder 18 år eller derover
  • Har oplevet traumer og rapporterer klinisk signifikante symptomer på traumatisk stress (klinisk forhøjet score på enten Posttraumatic Symptom Checklist (PCL-5) eller Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5) og/eller anden selvrapportering /interview bevis på væsentlige traumatiske stresssymptomer, som deltager ønsker støtte/program til
  • Behagelig at tale og skrive på engelsk
  • Full Scale Intelligence Quotient (FSIQ) score >= 65 (givet skriftlig karakter af Written Exposure Therapy) på Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2)
  • Adgang til enhed med internetadgang til telesundhedsbesøg

Ekskluderingskriterier:

  • Deltageren er ikke autist
  • Deltageren kan ikke forstå engelsk
  • Deltageren har ikke adgang til internetforbundet enhed til telesundhedsbesøg
  • Deltageren modtager Full Scale Intelligence Quotient (FSIQ) score < 65 på Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2)
  • Hvis der er væsentlige sikkerhedsmæssige betænkeligheder for en deltager (f.eks. overhængende risiko for skade på sig selv eller andre), kan hovedefterforskeren afgøre, om det ikke er i den voksnes bedste interesse at blive tilmeldt, da denne undersøgelse ikke yder pleje/ydelser vedr. aktiv risiko.

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: Skriftlig eksponeringsterapi
Adfærdsterapi: Skriftlig eksponeringsterapi via telehealth
Adfærdsmæssigt: Skriftlig eksponeringsterapi (WET) via telehealth
Skriftlig eksponeringsterapi (WET) via telehealth

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Posttraumatic Stress Disorder (PTSD) Symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Posttraumatic Symptom Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 is a self-report questionnaire of posttraumatic stress disorder symptoms. Total scores range from 0-80; higher scores indicate higher levels of posttraumatic stress disorder symptoms.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Depressive Symptoms on the Patient Health Questionnaire (PHQ) Scale
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The PHQ is a self-report measure of depressive symptoms. Total scores range from 0-27; higher scores reflect greater levels of depressive symptoms.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Anxiety Symptoms on the Anxiety Scale for Autism-Adults (ASA-A)
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Anxiety Scale for Autism-Adults (ASA-A) is a self-report measure for anxiety symptoms among autistic adults. Total scores range from 0 to 60; higher scores reflect higher anxiety symptoms.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Loneliness Symptoms on the University of California Los Angeles (UCLA) 3-Item Loneliness Scale
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The University of California Los Angeles (UCLA) 3-Item Loneliness Scale is a self-report measure for symptoms of loneliness. Scores range from 3 to 9; higher scores reflect higher levels of loneliness.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Psychological Adjustment Concerns on the Brief Adjustment Scale (BASE-6)
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Brief Adjustment Scale (BASE-6) is a brief self-report symptom monitoring measure for general psychological adjustment. Scores from from 6 to 42; higher scores reflect greater psychological adjustment concerns.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Experiential Avoidance Symptoms on the Brief Experiential Avoidance Questionnaire
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Brief Experiential Avoidance Questionnaire is a self-report measure of experiential avoidance. Scores range from 15 to 90; higher scores reflect greater levels of experiential avoidance.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Emotion Regulation Difficulties on the Difficulties in Emotion Regulation Scale (DERS-16)
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Difficulties in Emotion Regulation Scale (DERS-16) is a self-report measure of emotion regulation difficulties. Scores range from 16 to 80; higher scores reflect greater emotion regulation difficulties.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Stigma Towards Help-seeking on the Ultra-Brief Self-Stigma of Seeking Help (SSOSH-3) Scale
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Ultra Brief Self-Stigma of Seeking Help (SSOSH-3) Scale is a self-report measure of stigma towards seeking psychological support. Scores range from 3 to 15; higher scores reflect greater stigma.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Camouflaging on the Camouflaging Autistic Traits Questionnaire (CATQ)
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Camouflaging Autistic Traits Questionnaire (CATQ) is a self-report measure of masking autistic traits. Scores range from 25 to 175; greater scores reflect a higher level of camouflaging.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Sleep Difficulties on the Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep difficulties. Scores range from 0 to 21; higher scores reflect greater sleep difficulties.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Pain Intensity on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale.
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale is a self-report measure of pain intensity. Total scores range from 3 to 15; higher scores reflect more intense pain.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Pain Interference on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale.
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale is a self-report measure of pain interference. Total scores range from 8 to 40; higher scores reflect a greater level of pain interference.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Physical Activity as Assessed on Fitbit.
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Participants Fitbit measurements of number of steps (average past week daily steps) will be assessed via their Fitbit device.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Sleep Duration as Assessed on Fitbit.
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Participants Fitbit measurements of sleep duration in hours (past weekly nightly average in hours) will be assessed via their Fitbit device. A higher sleep duration indicates greater numbers slept.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Resting Heart Rate as Assessed on Fitbit.
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Participants Fitbit measurements of resting heart rate (past week daily average) will be assessed via their Fitbit device.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Autistic Quality of Life on the Autism Spectrum Quality of Life Scale.
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Autism Spectrum Quality of Life Scale is a self-report measure of quality of life relating to autism. Total scores range from 9 to 45, and higher scores reflect greater quality of life.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Overall Quality of Life on the World Health Organization Quality of Life Scale
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The World Health Organization Quality of Life Scale (WHO QOL) is a 26-item self-report questionnaire of quality of life. Summed total scores range from 26 to 130, and higher scores reflect greater quality of life.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Positive Autistic Identity on the Autism Spectrum Identity Scale (ASIS)
Tidsramme: Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
The Autism Spectrum Identity Scale (ASIS) is a 22-item self-report of autistic identity. Total scores range from 22 to 110, and higher scores reflect a more positive Autistic identity.
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

Samarbejdspartnere og efterforskere

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

Sponsor

University of Wyoming

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)

26. oktober 2023

Primær færdiggørelse (Faktiske)

12. februar 2025

Studieafslutning (Faktiske)

12. februar 2025

Datoer for studieregistrering

Først indsendt

25. april 2023

Først indsendt, der opfyldte QC-kriterier

7. maj 2023

Først opslået (Faktiske)

17. maj 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20230331CM03524

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