En pilot-deltakende programevaluering av et virtuelt traumestøtteprogram for autistiske voksne
5. juni 2026 oppdatert av: University of Wyoming
Effekten av en posttraumatisk stresslidelse (PTSD) intervensjon for autistiske voksne på bioatferdshelse
Målet med denne kliniske studien i én gruppe er å lære om den første effekten og gjennomførbarheten av telehelse-levert skriftlig eksponeringsterapi (WET) for autistiske voksne med traumatiske stresssymptomer. Hovedspørsmålene etterforskerne tar sikte på å svare på er:
- Avtar symptomene på posttraumatisk stresslidelse (PTSD) og samtidige psykiske helseproblemer etter å ha fått WET?
- Blir bioatferdsmessige helseutfall, inkludert objektive (Fitbit-indikatorer for aktivitet, søvn og hjertefrekvens) og subjektivt rapporterte helsevariabler (f.eks. søvn, smerte, helserelatert livskvalitet), bedre etter å ha mottatt WET?
- Hvordan opplever autistiske voksne VÅT, og hvordan kan dette programmet modifiseres og forbedres i fremtiden i samarbeid med autistiske voksne?
Deltakerne vil fullføre følgende som en del av studien, som i sin helhet fullføres over telehelse.
- Deltakerne vil først fullføre en innledende vurdering, som involverer korte mål på kognisjon og autistiske trekk, samt intervjuer og spørreskjemaer om PTSD, mental helse og fysisk helse. Hvis de er kvalifisert, vil deltakerne gå videre til følgende trinn:
- Kvalifiserte deltakere vil deretter begynne å bruke en Fitbit, som skal brukes under studiens varighet.
- Deltakerne vil deretter delta i 5 ukentlige virtuelle besøk som involverer WET-protokollen, inkludert ukentlig kort vurdering av PTSD og mental og fysisk helse.
- Deretter vil deltakerne gjennomføre et sjette virtuelt besøk uken etter hvor PTSD, mental og fysisk helse og behandlings-tilbakemeldinger vurderes.
- Til slutt vil deltakerne gjennomføre virtuelle besøk 1 og 6 måneder senere som involverer revurdering av PTSD og mental og fysisk helse.
Derfor er dette en pre-post enkelt gruppe design, hvor alle deltakere vil motta WET for å etablere initial effekt og gjennomførbarhet. Etterforskerne vil også rådføre seg med et autistisk rådgivende styre gjennom hele prosjektet, og gjøre tilpasninger som anbefalt i samråd med autistiske voksne. Målet er å bedre forstå den første effekten og gjennomførbarheten av WET for å støtte autistiske voksne som har opplevd traumer.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
28
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Wyoming
-
Laramie, Wyoming, Forente stater, 82071
- University of Wyoming
-
-
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
Nei
Beskrivelse
Inklusjonskriterier:
- Autistisk
- Alder 18 år eller over
- Har opplevd traumer og rapporterer klinisk signifikante symptomer på traumatisk stress (klinisk forhøyet skår på enten Posttraumatic Symptom Checklist (PCL-5) eller Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5), og/eller annen selvrapportering /intervju bevis på betydelige traumatiske stresssymptomer som deltaker ønsker støtte/program for
- Komfortabel å snakke og skrive på engelsk
- Full Scale Intelligence Quotient (FSIQ) score >= 65 (gitt skriftlig karakter av Written Exposure Therapy) på Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2)
- Tilgang til enhet med internettilgang for telehelsebesøk
Ekskluderingskriterier:
- Deltakeren er ikke autist
- Deltakeren kan ikke forstå engelsk
- Deltakeren har ikke tilgang til Internett-tilkoblet enhet for telehelsebesøk
- Deltakeren mottar Full Scale Intelligence Quotient (FSIQ) score < 65 på Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2)
- Hvis det er betydelige sikkerhetsproblemer for en deltaker (f.eks. overhengende risiko for skade på seg selv eller andre), kan hovedetterforskeren avgjøre om det ikke er i den voksnes beste interesse å bli registrert gitt at denne studien ikke gir omsorg/tjenester knyttet til aktiv risiko.
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: Skriftlig eksponeringsterapi
Atferdsterapi: Skriftlig eksponeringsterapi via telehelse
|
Skriftlig eksponeringsterapi (WET) via telehelse
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
26. oktober 2023
Primær fullføring (Faktiske)
12. februar 2025
Studiet fullført (Faktiske)
12. februar 2025
Datoer for studieregistrering
Først innsendt
25. april 2023
Først innsendt som oppfylte QC-kriteriene
7. mai 2023
Først lagt ut (Faktiske)
17. mai 2023
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Traumer og stressorerelaterte lidelser
- Autismespektrumforstyrrelse
- Psykiske lidelser
- Nevroutviklingsforstyrrelser
- Barneutviklingsforstyrrelser, gjennomgripende
- Stresslidelser, traumatiske
- Sår og skader
- Autistisk lidelse
- Stresslidelser, posttraumatisk
- Kjemiske fenomener
- Hydrofobe og hydrofile interaksjoner
- Overflateegenskaper
- Fuktbarhet
Andre studie-ID-numre
- 20230331CM03524
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