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Идёт набор NCT06273527

Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)

Фаза II / Фаза III С лечением Anxiety Disorders Depression Post Traumatic Stress Disorder

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: COGENT, Sham Program.
Кому может быть актуально
Состояния в реестре: Anxiety Disorders, Depression, Post Traumatic Stress Disorder. Базовые параметры: 21 лет — 55 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
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Официальное название

Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol

Обзор

The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to one of two groups. Group 1 will receive a computer-based program that is designed as a cognitive training intervention and Group 2 will receive a similar computer-based exercise that researchers think will be less effective in training thinking skills (also known as a control or sham condition). Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment.

Подробное описание

Mood, anxiety, and traumatic stress disorders are common psychiatric conditions - affecting over 40 million U.S. adults - and are leading causes of disability worldwide. People with these conditions are commonly plagued by difficulty controlling distressing personal thoughts and memories, collectively referred to as repetitive negative thinking symptoms. Models suggest that repetitive negative thinking is driven by executive functioning deficits, such that cognitive resources are insufficient to downregulate unwanted thoughts. Executive functioning deficits could be a promising treatment target but are not typically addressed with existing interventions. The long-term goal advanced by this project is to develop effective, mechanistic cognitive training programs that can improve cognition and reduce symptoms associated with mood, anxiety, and traumatic stress disorders. The objectives of this proposal is to evaluate the cognitive effects of the optimized computer-based cognitive training intervention relative to a sham training program (ST). The central hypothesis is that the cognitive training intervention will enhance executive functioning and will lead to a reduction of repetitive negative thinking in mood, anxiety, and traumatic stress disorders. The project will randomize participants with depression, anxiety, and/or traumatic stress disorders to a cognitive training intervention program or a sham training program. The investigators will examine executive functioning change with cognitive task performance and functional neuroimaging assessments.

Вмешательства

  • Поведенческое COGENT
    COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
  • Другое Sham Program
    The Sham Program will be a similar task which researchers think will be less effective in training thinking skills.

Первичные конечные точки

  • Change in cognitive performance [Срок оценки: Baseline, Week 4, Week 8, Week 16]
Вторичные конечные точки (3)
  • Reading Span Blood Oxygen Level Dependent (BOLD) Response [Срок оценки: Baseline, Week 4]
  • Neuropsychological Performance [Срок оценки: Baseline, Week 4, Week 8, Week 16]
  • Repetitive Negative Thinking (RNT) [Срок оценки: Baseline, Week 4,Week 8, Week 16]

Критерии участия

Критерии включения

  • age 21-55
  • fluent in English
  • diagnosis of mood, anxiety, or traumatic stress disorder
  • clinically elevated repetitive negative thinking
  • outpatient status
  • 6-week stability if taking selective serotonin reuptake inhibitor (SSRI) medications

Критерии исключения

  • past year diagnosis of severe alcohol or moderate or greater substance use disorder
  • lifetime history of psychotic or bipolar I disorder
  • acute suicidality necessitating immediate clinical intervention
  • neurodegenerative or neurodevelopmental disorders
  • history of moderate or severe traumatic brain injury or other known neurological condition
  • sensory deficits that would preclude completing tasks
  • conditions unsafe for completing MRI scanning (e.g., metal in body)
  • current pregnancy
  • currently receiving psychosocial treatment
  • currently receiving psychiatric pharmacotherapy, except SSRIs

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UC San Diego — San Diego

Идентификаторы

NCT: NCT06273527 · 808681

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗