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Набор скоро начнётся NCT06656780

Stress Inoculation Training (SIT): An Evidence-Based, Military Aligned Psychological Performance and Health Sustainment Prototype

Без фазы С лечением Stress, Psychological

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: SIT, DCA-FF.
Кому может быть актуально
Состояния в реестре: Stress, Psychological. 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 →

Обзор

The purpose of this study is to demonstrate the feasibility of augmenting existing/traditional Navy military training with the manualized SIT Core Protocol (CP) utilizing the established augmentation procedure set as measured by feasibility, utility, and satisfaction metrics (CSQ-8) and to examine the relative effectiveness of the SIT-CP by comparison to standard military training in a controlled trial examining outcomes of stress tolerance, psychological health, resilience and occupational performance in Sailors undergoing DCA Firefighting Training (pre- to post-training), while collecting implementation data.

Вмешательства

  • Поведенческое SIT
    Participants will undergo 2 day (8 hours each) Stress Inoculation Training . This will be done in 3 steps: Step 1: focus on education about the human body and brain and shift to hands on skills practice to improve performance in stressful conditions and is designed to improve self-and-situational awareness and the ability to manipulate reactions and responses in the body on purpose to enhance performance Step 2: focuses on improving mental self-awareness and gaining skills in Mental Agility an
  • Поведенческое DCA-FF
    Participants will undergo 8-week Standard Firefighting Training

Первичные конечные точки

  • Changes in perceived management of stress as assessed by the Perceived Stress Scale (PSS) [Срок оценки: Baseline, about 3 weeks from baseline, about 6 weeks form baseline, about 11 weeks form baseline, end of study (an average of 19 weeks form baseline)]
  • Change in resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC) [Срок оценки: Baseline, about 3 weeks from baseline, about 6 weeks form baseline, about 11 weeks form baseline, end of study (an average of 19 weeks form baseline)]
Вторичные конечные точки (12)
  • Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric [Срок оценки: week 2]
  • Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric [Срок оценки: week 4]
  • level of confidence with delivering the training elements within the Module and the full Module as assessed by the SIT Feasibility Rubric [Срок оценки: week 2]
  • level of confidence with delivering the training elements within the Module and the full Module as assessed by the SIT Feasibility Rubric [Срок оценки: week 4]
  • Utility as assessed by the standardized self-assessment tool [Срок оценки: week 2]
  • Utility as assessed by the standardized self-assessment tool [Срок оценки: week 4]
  • Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8) [Срок оценки: week 2]
  • Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8) [Срок оценки: week 3]
  • Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8) [Срок оценки: week 11(end of study)]
  • Firefighting Observational Rubrics [Срок оценки: week 6]
  • Change in adaptation to stress as assessed by the Situational Adaptation to Stress Scale for Human Performance (SASS-HP) [Срок оценки: Baseline, about 3 weeks from baseline, about 6 weeks form baseline]
  • Change in adaptation to stress as assessed by the Situational Adaptation to Stress Scale for Human Performance (SASS-HP) [Срок оценки: about 11 weeks form baseline, end of study (about 19 weeks form baseline)]

Критерии участия

Критерии включения

  • US Navy service members on Active Duty or Reserve status
  • be fluent in English.
  • be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
  • have access to a SmartPhone, computer, or tablet to utilize and access the virtual classroom.
  • agree to undergo psychometric and operational performance testing and participate in ongoing assessments throughout the study duration.
  • be willing to comply with all study procedures, able to complete all assessments independently, and available for the duration of the study (with reasonable accommodations for military operational demands as they arise).

Критерии исключения

  • Active suicidal ideation as assessed by the Investigator at screening or as identified during the study.
  • Clinically significant history of psychotic disorder, bipolar spectrum disorder, or neurodegenerative disease/dementia as assessed by the Investigator.
  • Active severe substance abuse as assessed by the investigator in accordance with The Diagnostic and Statistical Manual of Mental Illnesses (DSM-5) Substance Abuse Disorder criteria, or presence of illicit substance abuse.
  • They are currently undergoing another form of treatment other than supportive therapy (>2 times per month).
  • Any other condition/situation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06656780 · HSC-MS-24-0756

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗