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Evaluación participativa piloto de un programa virtual de apoyo en trauma para adultos autistas

5 de junio de 2026 actualizado por: University of Wyoming

Eficacia de una intervención de trastorno de estrés postraumático (TEPT) para adultos autistas en salud bioconductual

El objetivo de este ensayo clínico de un solo grupo es conocer la eficacia inicial y la viabilidad de la terapia de exposición escrita (WET) proporcionada por telesalud para adultos autistas con síntomas de estrés traumático. Las principales preguntas que los investigadores pretenden responder son:

  • ¿Disminuyen los síntomas del trastorno de estrés postraumático (TEPT) y los problemas de salud mental concurrentes después de recibir WET?
  • ¿Mejoran los resultados de salud biocomportamentales, incluidos los objetivos (indicadores de Fitbit de actividad, sueño y frecuencia cardíaca) y las variables de salud informadas subjetivamente (p. ej., sueño, dolor, calidad de vida relacionada con la salud), después de recibir WET?
  • ¿Cómo experimentan los adultos autistas WET y cómo se puede modificar y mejorar este programa en el futuro en colaboración con adultos autistas?

Los participantes completarán lo siguiente como parte del estudio, que se completa en su totalidad a través de telesalud.

  • Los participantes primero completarán una evaluación inicial, que incluirá medidas breves de cognición y rasgos autistas, así como entrevistas y cuestionarios sobre TEPT, salud mental y salud física. Si son elegibles, los participantes procederán a los siguientes pasos:
  • Los participantes elegibles comenzarán a usar un Fitbit, que se utilizará durante la duración del estudio.
  • Luego, los participantes participarán en 5 visitas virtuales semanales que involucran el protocolo WET, incluida una breve evaluación semanal de PTSD y salud mental y física.
  • Luego, los participantes completarán una sexta visita virtual la semana siguiente en la que se evaluarán el TEPT, la salud mental y física y los comentarios sobre el tratamiento.
  • Por último, los participantes completarán visitas virtuales 1 y 6 meses después, lo que implicará una nueva evaluación del TEPT y la salud mental y física.

Por lo tanto, este es un diseño de grupo único previo y posterior, donde todos los participantes recibirán WET para establecer la eficacia y viabilidad iniciales. Los investigadores también consultarán con un consejo asesor autista a lo largo del proyecto y harán las adaptaciones recomendadas en consulta con adultos autistas. El objetivo es comprender mejor la eficacia inicial y la viabilidad de WET para apoyar a los adultos autistas que han experimentado un trauma.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

28

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Wyoming
      • Laramie, Wyoming, Estados Unidos, 82071
        • University of Wyoming

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Autista
  • 18 años o más
  • Ha experimentado un trauma e informa síntomas clínicamente significativos de estrés traumático (puntuación clínicamente elevada en la Lista de verificación de síntomas postraumáticos (PCL-5) o en la Entrevista clínica estructurada para el Manual diagnóstico y estadístico de los trastornos mentales (SCID-5) y/u otro autoinforme /entrevista evidencia de síntomas significativos de estrés traumático para los cuales el participante quiere apoyo/programa
  • Cómodo hablando y escribiendo en inglés.
  • Puntuación del cociente de inteligencia de escala completa (FSIQ) >= 65 (dada la naturaleza escrita de la terapia de exposición escrita) en la escala abreviada de inteligencia de Wechsler, segunda edición (WASI-2)
  • Acceso a dispositivo con acceso a internet para visitas de telesalud

Criterio de exclusión:

  • El participante no es autista
  • El participante no puede entender inglés.
  • El participante no tiene acceso a un dispositivo conectado a Internet para visitas de telesalud
  • El participante recibe una puntuación de <65 en el cociente de inteligencia de escala completa (FSIQ) en la escala abreviada de inteligencia de Wechsler, segunda edición (WASI-2)
  • Si existen preocupaciones de seguridad significativas para cualquier participante (p. ej., riesgo inminente de daño a sí mismo o a otros), el investigador principal puede determinar si no es lo mejor para el adulto inscribirse dado que este estudio no brinda atención/servicios relacionados con riesgo activo.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Terapia de exposición escrita
Terapia conductual: Terapia de exposición escrita a través de telesalud
Conductual: Terapia de exposición escrita (WET) a través de telesalud
Terapia de exposición escrita (WET) a través de telesalud

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Posttraumatic Stress Disorder (PTSD) Symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Depressive Symptoms on the Patient Health Questionnaire (PHQ) Scale
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Autistic Quality of Life on the Autism Spectrum Quality of Life Scale.
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Wyoming

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de octubre de 2023

Finalización primaria (Actual)

12 de febrero de 2025

Finalización del estudio (Actual)

12 de febrero de 2025

Fechas de registro del estudio

Enviado por primera vez

25 de abril de 2023

Primero enviado que cumplió con los criterios de control de calidad

7 de mayo de 2023

Publicado por primera vez (Actual)

17 de mayo de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20230331CM03524

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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