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Идёт набор NCT07542431

Impact of Dog Adoption and Training in Veterans With Post-traumatic Stress Symptoms and/or Other Mental Health Conditions

Без фазы С лечением Posttraumatic Stress Symptoms Mental Health Conditions

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: Dog training.
Кому может быть актуально
Состояния в реестре: Posttraumatic Stress Symptoms, Mental Health Conditions. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Assessment of Biopsychosocial Indicators Linked to Canine Intervention Treatment Response in Veterans With Post-traumatic Stress Symptoms and/or Other Mental Health Conditions

Обзор

The goal of this single-arm study is to learn if a dog adoption and training program can treat, prevent in \[describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers\]. The main questions it aims to answer are: * Does the dog adoption and training program decrease posttraumatic stress symptoms in veterans with self-reported posttraumatic stress symptoms? * Does the dog adoption and training program decrease stress and improve psychosocial health in veterans with self-reported posttraumatic stress symptoms? * Does the dog adoption and training program decrease inflammation, increase oxytocin, and change the structure and resting-state function of specific brain regions in veterans with self-reported posttraumatic stress symptoms? Participants will: * Attend eight one-hour professional dog training sessions within a 10-week period. * Visit the clinical research unit four times during the study for data collection.

Вмешательства

  • Другое Dog training
    Eight, one-hour professional dog training sessions over 8-10 weeks

Первичные конечные точки

  • Change in self-reported posttraumatic stress disorder (PTSD) symptoms from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]
Вторичные конечные точки (11)
  • Change in depression symptom severity from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]
  • Change in anxiety symptom severity from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]
  • Change in perceived stress severity from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]
  • Change in sleep disturbance from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]
  • Change in loneliness from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]
  • Change in alcohol use from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]
  • Change in cannabis use from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]
  • Change in salivary oxytocin levels from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]
  • Change in Interleukin-1 beta (IL-1β) from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]
  • Change in Interleukin-6 (IL-6) from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]
  • Change in tumor necrosis factor-alpha (TNF-alpha) from baseline to 4 weeks post-intervention [Срок оценки: From enrollment to 4 weeks post-intervention]

Критерии участия

Критерии включения

  • Military veteran with self-reported posttraumatic stress symptoms and/or other mental health conditions
  • Over 18 years of age
  • Applied and approved to adopt a shelter dog for training through the Humane Society of Broward County in Fort Lauderdale, Florida
  • English speaker (written and spoken)
  • Home internet access via tablet, computer or smartphone.

Критерии исключения

  • Fear of dogs
  • Allergies to pet dander
  • Uncorrected hearing or visual impairment.

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
  • Florida Atlantic University — Boca Raton

Идентификаторы

NCT: NCT07542431 · IRB2310227

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗