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Идёт набор NCT07055633

Improving Cognitive Rehabilitation Outcomes

Без фазы С лечением Mild Traumatic Brain Injury Posttraumatic 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: CCT+MBLT, CCT+ION.
Кому может быть актуально
Состояния в реестре: Mild Traumatic Brain Injury, Posttraumatic Stress Disorder. Базовые параметры: от 18 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

Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD

Обзор

Posttraumatic stress disorder (PTSD) and mild TBI (mTBI) frequently co-occur in post-9/11 Veterans, and together are associated with worse cognitive performance, mental health, everyday functioning, community integration, quality of life, and treatment response than either condition alone. Additional comorbidities, such as depression and sleep disturbance, are common and further exacerbate these problems. The investigators will investigate Compensatory Cognitive Training (CCT) and Morning Bright Light Therapy (MBLT) vs Negative Ion Generator (ION), to directly target cognition, depression, and sleep disturbance and to improve CCT-associated rehabilitation outcomes. The investigator's randomized controlled trial in 144 Veterans with mTBI+PTSD across two VA sites will compare cognition, functioning, and other secondary outcomes following CCT+MBLT vs. CCT+ION. This study addresses the significant gap in services and evidence-based treatments for Veterans with mTBI+PTSD.

Подробное описание

The investigators aim to compare CCT+MBLT with CCT+ION for improving cognition, functioning, and secondary outcomes in Veterans with mTBI+PTSD.

Objective cognitive performance and everyday functioning are co-primary outcomes. Depression and sleep disturbance are target mechanisms and secondary outcomes include PTSD symptom severity, post-concussive symptom severity, cognitive symptom severity, and quality of life.

Improvements in mood and sleep will be investigated as mediators. To explore for whom these interventions are most effective, the investigators will evaluate whether individual difference variables (e.g., demographics, premorbid functioning, treatment adherence) or baseline performance on primary and secondary outcome measures moderate intervention-related improvements in objective cognitive performance and everyday functioning.

The investigators will enroll a representative sample of 144 post-9/11 Veterans with mTBI+PTSD at two VA sites (San Diego and Portland). Assessments will be conducted at baseline, mid-treatment (5 weeks), post-treatment (10 weeks), and three-month follow-up.

Вмешательства

  • Устройство CCT+MBLT
    Compensatory Cognitive Training + Morning Bright Light Therapy (Aurora LightPad)
  • Устройство CCT+ION
    Compensatory Cognitive Training + Negative Ion Generator (SphereOne)

Первичные конечные точки

  • Objective Cognitive Performance [Срок оценки: baseline, 10 weeks]
  • Functioning [Срок оценки: baseline, 10 weeks]
Вторичные конечные точки (8)
  • Insomnia Severity Index [Срок оценки: baseline, 10 weeks]
  • Pittsburgh Sleep Quality Index [Срок оценки: baseline, 10 weeks]
  • Total Sleep Time [Срок оценки: baseline, 10 weeks]
  • Patient Health Questionnaire-9 [Срок оценки: baseline, 10 weeks]
  • PTSD Checklist for DSM-5 [Срок оценки: baseline, 10 weeks]
  • Neurobehavioral Symptom Inventory [Срок оценки: baseline, 10 weeks]
  • Subjective cognitive functioning [Срок оценки: baseline, 10 weeks]
  • World Health Organization Quality of Life [Срок оценки: baseline, 10 weeks]

Критерии участия

Критерии включения

  • Post 9/11 Veterans enrolled at VA San Diego or VA Portland
  • Ability to provide informed consent
  • Living independently
  • History of mTBI confirmed by OSU-TBI
  • Current diagnosis of PTSD confirmed by CAPS-5
  • Current cognitive concerns ("Do you have concerns about your cognition, thinking, attention, or memory?")
  • Current concern regarding depression and/or sleep disturbance; defined by a score of 5 on the PHQ-9 and/or 8 on the ISI, respectively (score of 2 or higher on ISI item 1, 2, or 3, reflecting at least "moderate" difficulty with falling asleep, staying asleep, or waking up too early in the morning)

Критерии исключения

  • Current substance use disorder with <30 days abstinence
  • History of primary psychotic disorder
  • History of moderate to severe TBI (loss of consciousness >30 minutes)
  • History of macular degeneration or bipolar disorder (both contraindicated for bright light therapy)
  • Not work night or swing shift schedules
  • Untreated obstructive sleep apnea either via self-report or a score 5 on the STOP-BANG
  • Current engagement in bright light therapy
  • Auditory or visual impairments precluding participation in assessments or treatments

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 · 2 центра
  • VA San Diego Healthcare System, San Diego, CA — San Diego
  • VA Portland Health Care System, Portland, OR — Portland

Идентификаторы

NCT: NCT07055633 · RRD1-012-24W

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗