Concussion Recovery and Support Program
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: CRISP (Concussion Recovery and Support Program).
- Кому может быть актуально
- Состояния в реестре: Brain Concussion, Mild Traumatic Brain Injury, Headache. Базовые параметры: 18 лет — 29 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 →
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Официальное название
Pilot Study of Concussion Recovery and Support Program (CRISP)
Обзор
Pilot randomized controlled trial (RCT) comparing a novel intervention Concussion Recovery and Support Program (CRISP) for adolescents and young adults (AYA) 18-29 yo with concussion/ mild TBI.
Подробное описание
The authors are conducting a pilot study to examine the feasibility, acceptability and pilot efficacy of a novel intervention called CRISP for young adults with persistent concussion/ mTBI. CRISP is an adaptation of an evidence-based treatment for chronic pain called Emotional Awareness and Expression Therapy (EAET). EAET targets underlying emotional responses that appear to drive persistent symptoms, and has been found effective for treating headache and other types of pain in randomized controlled trials with moderately strong effect sizes (0.4-0.5).
Individuals who participate in this study will complete 6 sessions of CRISP with a trained therapist over zoom (each 60 minutes) and will also fill out surveys at multiple time points (baseline, 5 weeks, 10 weeks).
Aim 1: Evaluate feasibility and acceptability of CRISP with a pilot study of n=40 individuals with concussion ages 18-30 years who are struggling with headache. Hypothesis: CRISP will be a feasible and acceptable approach to treating AYA with concussion.
Aim 2: Collect pilot data regarding efficacy of CRISP for reducing concussion symptoms and improving function (particularly regarding headache). Hypothesis: Pilot data may show benefit from this approach for improving recovery, though we do not expect significance given the sample size.
Вмешательства
- Поведенческое CRISP (Concussion Recovery and Support Program)
Mental health intervention targeting suppressed emotion with a goal of facilitating recovery.
Первичные конечные точки
- Treatment Evaluation Inventory, short form [Срок оценки: 10 weeks]
Вторичные конечные точки (9)
- HIT6 (Headache Impact Test, 6 item) [Срок оценки: Baseline, 5 weeks, 10 weeks (trajectory over time)]
- PROMIS fatigue short form [Срок оценки: Baseline/ 5 weeks/ 10 weeks (trajectory over time)]
- Fear of Concussive Symptoms Questionnaire (FOCSQ) [Срок оценки: Baseline/ 5 weeks/ 10 weeks (trajectory over time)]
- Post Concussion Symptom Scale (PCSS) [Срок оценки: Baseline/ 5 weeks/ 10 weeks (trajectory over time)]
- PROMIS (Patient Reported Outcome Measurement Information System) anxiety [Срок оценки: Baseline/ 5 weeks/ 10 weeks (trajectory over time)]
- PROMIS depression [Срок оценки: Baseline/ 5 weeks/ 10 weeks (trajectory over time)]
- Emotional Approach Coping (EAC) [Срок оценки: Baseline/ 5 weeks/ 10 weeks (trajectory over time)]
- Psychological Insight [Срок оценки: 10 weeks (post-intervention only)]
- PROMIS sleep disturbance SF [Срок оценки: Baseline/ 4 weeks/ 8 weeks (trajectory over time)]
Критерии участия
Критерии включения
- Diagnosed with a concussion and at least 2 weeks from injury but less than two years.
- New or worsening headache since concussion
- Had at least one day with headache last week of moderate severity or two days with headache of any severity
Критерии исключения
- Non-English speaking
- Chronic medical illness/ medical complexity
- Housing instability
- Acute mental health issues such as active suicidality, psychiatric hospitalization within the past 6 months, ER visit for suicidality in the past 6 months or experiencing psychosis or delusions
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 2 центра
- Seattle Children's Research Institute — Seattle
- University of Washington — Seattle
Публикации
- Lumley MA, Schubiner H. Emotional Awareness and Expression Therapy for Chronic Pain: Rationale, Principles and Techniques, Evidence, and Critical Review. Curr Rheumatol Rep. 2019 May 23;21(7):30. doi: 10.1007/s11926-019-0829-6. PMID 31123837
Идентификаторы
NCT: NCT07097792 · 00005446