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Идёт набор NCT06828471

Social Cognition Training in Individuals With Huntington's Disease

Без фазы С лечением Huntington's Disease (HD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Social Cognition Training.
Кому может быть актуально
Состояния в реестре: Huntington's Disease (HD). Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Social Cognition Training in Individuals With Huntington's Disease: A Feasibility Study

Обзор

Individuals with Huntington's Disease have impaired social cognition, which is the domain of cognition that allows individuals to understand others' perspectives so that they can navigate interpersonal actions successfully (e.g., understanding someone may be sad based of their facial emotion or tone of voice and then responding in a sympathetic manner). Impaired social cognition is associated with impaired social functioning, poor psychological wellbeing and increased caregiver burden, which is known to be significant among those who care for individuals with Huntington's Disease. Computerized social cognition training has been shown to improve social cognition in individuals with schizophrenia, who, like individuals with Huntington's disease, have cognitive impairments. The investigators propose a pilot study of computerized social cognition training in individuals with Huntington's disease. This will be a feasibility study that aims to show that social cognition training in HD can be studied in preparation for a larger randomized controlled trial. The investigators hypothesize that social cognition training can improve social cognition, social functioning, and quality of life in individuals with Huntington's Disease and decrease caregiver burden among those who care for individuals with Huntington's Disease.

Вмешательства

  • Поведенческое Social Cognition Training
    Neuroplasticity-based social cognition training that targets a range of social cognition skills, including visual and vocal affect perception, social cue perception, theory of mind, self-referential style, and empathy

Первичные конечные точки

  • Proportion of participants willing to consider study out of those who have been approached [Срок оценки: 32 months]
  • Number of participants who adhered and completed the study [Срок оценки: 32 months]
  • Ease of program on a scale of 1 to 5 with 5 being "very easy." [Срок оценки: 32 months]
  • Participant satisfaction with the program [Срок оценки: 32 months]
Вторичные конечные точки (6)
  • Change in accuracy on a facial emotion recognition task [Срок оценки: 6-12 weeks]
  • Change in accuracy on an empathic accuracy task [Срок оценки: 6-12 weeks]
  • Change in score on the Quality of Life in Neurological Disorders Ability to Participate in Social Roles and Activities (scores range from 45 to 225; higher score indicates better outcome) [Срок оценки: 6-12 weeks]
  • Change in score on the Quality of Life in Neurological Disorders Satisfaction with Social Roles and Activities Questionnaire (scores range from 45 to 225; higher score indicates better outcome) [Срок оценки: 6-12 weeks]
  • Change in score on the Quality of Life in Neurological Disorders Positive Affect and Wellbeing Questionnaire (scores range from 23 to 115; higher score indicates better outcome) [Срок оценки: 6-12 weeks]
  • Change in score on the Caregiver Burden Inventory (scores range from 0-96; lower score indicates better outcome) [Срок оценки: 6-12 weeks]

Критерии участия

Inclusion Criteria for Individual with Huntington's Disease

  • Diagnosed with Huntington's Disease based on genetic testing
  • Must be between 18 and 65 years of age
  • Native English speaker who is literate in English
  • Stable psychotropic medication regimen for 4 weeks
  • Must have a score of "somewhat easily" on all items in the CPQ-12
  • MOCA >18
  • Completed 12 years of schooling
  • Access to laptop or mobile device
  • Willingness to come in person 6-12 weeks after first visit

Inclusion Criteria for Caregiver of Individual with Huntington's Disease

  • Lives with patient
  • Must be between 18 and 65 years of age
  • Native English speaker who is literate in English
  • MOCA >26
  • Willingness to come in person within 6-12 weeks after first visit

Exclusion Criteria for Individual with Huntington's Disease

  • Any known neurological condition (other than Huntington's Disease).
  • History of learning and/or intellectual disabilities
  • Currently actively involved in any other interventional trial (i.e. have begun the intervention) or within 4 weeks of completing the final assessments of an interventional trial.
  • Currently regularly completing a computerized cognitive training intervention.
  • Active suicidal ideation with some intent

Exclusion Criteria for Caregiver of Individual with Huntington's Disease

  • Inability to provide informed consent
  • Active suicidal ideation with some intent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Rush University Medical Center — Chicago

Идентификаторы

NCT: NCT06828471 · 24112605

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗