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Набор по приглашению NCT06723834

Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD

Без фазы С лечением Stress Disorders, Post-Traumatic PTSD Animal-Human Bonding Combat Stress Disorders

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: Psychiatric Service Dog, Prolonged Exposure Therapy.
Кому может быть актуально
Состояния в реестре: Stress Disorders, Post-Traumatic, PTSD, Animal-Human Bonding, Combat Stress Disorders. 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

Psychiatric Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD: A Randomized Clinical Trial

Обзор

This study investigates the impact of Service Dog partnership on the effectiveness of Prolonged Exposure Therapy. We will learn whether Service Dog partnership in combination with Prolonged Exposure Therapy treatment can help Veterans with PTSD.

Подробное описание

Posttraumatic stress disorder (PTSD) is common among military Service Members and Veterans (hereafter, "Veterans"). Symptoms of flashbacks, nightmares, and panic attacks can have devastating impacts on Veterans and their families. Suicide and suicidality are also closely linked to PTSD, and the rate of death by suicide among Veterans is nearly double that of the civilian population. PTSD is also difficult to treat. Many Veterans either do not seek treatment at all, or if they start treatment, do not finish. Even if treatment is completed, many Veterans still suffer symptoms and even retain their PTSD diagnosis. There is a critical need to find ways to reduce dropout rates, thus improving the effectiveness of existing, gold-standard treatments and promoting positive outcomes for Veterans and their families.

In their search for effective treatments, some Veterans are turning to add-on interventions for PTSD, such as partnership with a Service Dog. Under the Americans with Disabilities Act (ADA), service dogs are defined as dogs trained to perform specific tasks to mitigate a disability. Service dogs for PTSD are trained in tasks including detecting and alerting to signs of distress to interrupt anxiety and panic attacks and retrieving medication. In addition to trained tasks, service dogs live with the Veterans to provide emotional value as a source of comfort and companionship. Under the ADA guidance, Veterans with PTSD have the legal right to be accompanied by their service dog in public places such as grocery stores, workplaces, and schools. In this study, service dogs will be sourced from participating service dog organizations.

Service Dogs for Veterans are not only increasingly in demand, but a growing body of evidence demonstrates that Service Dogs can significantly improve the lives of Veterans with PTSD. Unfortunately, there is currently no research exploring whether adding a Service Dog will impact the effectiveness of evidence-based PTSD treatments, such as Prolonged Exposure Therapy (PE). Prolonged Exposure Therapy is a gold-standard, frontline treatment for PTSD that is highly effective, but has high rates of dropout.

PE teaches individuals with PTSD to gradually approach trauma-related memories, feelings, and situations that they have been avoiding since their trauma. By confronting these challenges, participants can decrease their PTSD symptoms. PE treatment typically last 12 weeks for 75-90 minutes, once per week.

Initial findings suggest that Service Dogs may help Veterans stay in Prolonged Exposure Therapy resulting in better treatment outcomes. However, some mental health professionals worry that Service Dogs may in fact interfere with treatment goals. This novel study is designed to help understand the impact of Service Dog partnership on the effectiveness of Prolonged Exposure Therapy.

Вмешательства

  • Другое Psychiatric Service Dog
    Partnership with a trained service dog for PTSD.
  • Поведенческое Prolonged Exposure Therapy
    12 weeks of Prolonged Exposure once per week.

Первичные конечные точки

  • PTSD Symptom Severity (Self-report) [Срок оценки: 3 months after start of PE]
Вторичные конечные точки (7)
  • PTSD Symptom Severity (Clinician-assessed) [Срок оценки: 3 months after start of PE]
  • PTSD Diagnosis [Срок оценки: 3 months after start of PE]
  • Depression [Срок оценки: 3 months after start of PE]
  • Anxiety [Срок оценки: 3 months after start of PE]
  • Emotional affect [Срок оценки: 3 months after start of PE]
  • Satisfaction with life [Срок оценки: 3 months after start of PE]
  • Mental health [Срок оценки: 3 months after start of PE]

Критерии участия

Критерии включения

  • Applied for and approved to receive a psychiatric service dog from a service dog organization participating in the study
  • Diagnosis of PTSD on the CAPS-5-R

Критерии исключения

  • Current service dog
  • Current participation in Prolonged Exposure Therapy

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 · 1 центр
  • University of Arizona — Tucson

Идентификаторы

NCT: NCT06723834 · HT9425-24-1-0178 · CDMRP-PR230987

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗