Меню
Идёт набор NCT07146633

Efficacy of an EMDR App for PTSD and SUD

Без фазы С лечением Posttraumatic Stress Disorder (PTSD) Substance Use 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: A-EMDR, Treatment as Usual (TAU).
Кому может быть актуально
Состояния в реестре: Posttraumatic Stress Disorder (PTSD), Substance Use 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Efficacy and Feasibility of Autonomous Eye Movement Desensitization and Reprocessing (A-EMDR) for Patients With Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders

Обзор

The current proposal is aimed to confirm the efficacy of this novel therapeutic method (autonomous eye movement desensitization and reprocessing; A-EMDR) in a patient group (PTSD and SUD), and to assess the feasibility of the application within this group. While there is no basis to assume lower efficacy of the treatment with this population, confirming that hypothesis is an important and helpful step before a full-performance research study can be initiated. Furthermore, this study proposal will provide additional information regarding the feasibility for this population, which will allow for a more tailored approach in future study.

Подробное описание

This is an open-label pilot randomized, wait-list controlled trial evaluating A-EMDR for the treatment of PTSD in patients with SUD for four weeks with a follow up at week eight. Primary outcomes will be measured at the end of the study (week 4) for both groups and at follow up (week 8) for the A-EMDR group.

Вмешательства

  • Поведенческое A-EMDR
    Participants in the treatment group will receive Autonomous Eye movement desensitization and reprocessing (A-EMDR) therapy delivered through an app on their device. Participants will be asked to complete 3 sessions per week for 4 consecutive weeks. During the treatment period, participants will also attend clinical sessions which will focus on factors such as the therapeutic alliance, assessing the participant's current state, reviewing recent alcohol and drug use, reviewing PTSD symptoms, provi
  • Другое Treatment as Usual (TAU)
    Participants are advised to continue seeking mental health care as usual and will be added to a waitlist for A-EMDR. They will also attend two clinical sessions. Sessions may last 15 to 60 minutes and will focus on factors such as the therapeutic alliance, assessing the participant's current state, reviewing recent alcohol and drug use, reviewing PTSD symptoms, providing a brief counseling intervention, enhancing positive expectancies, inspiring hope, and encouraging adherence to the study proto

Первичные конечные точки

  • Changes in PTSD symptoms and alcohol/drug consumption during 4 weeks of treatment. [Срок оценки: From enrollment to the end of treatment at 4 weeks]
Вторичные конечные точки (1)
  • The feasibility and engagement of A-EMDR during 4 weeks of treatment. [Срок оценки: From enrollment to the end of the treatment at 4 weeks]

Критерии участия

Критерии включения

  • Aged 18-years old or older
  • Fluent in English
  • Diagnosed with PTSD by the PTSD Checklist for DSM-5 (PCL-5 past month version score >32)
  • Diagnosed with past-year substance use disorder other than caffeine by structured clinical interview for DSM-5 (SCID-5)
  • Agrees not to participate in other treatments during the study duration (e.g., mindfulness, yoga, biofeedback, self-hypnosis or tai chi) except individuals who have been already on continuous therapies for at least three months

Критерии исключения

  • Diagnosis of a severe or unstable mental illness that precludes safe participation in the study by a healthcare practitioner such as acute psychosis or mania diagnosed by a healthcare practitioner
  • Current suicidality risk as indicated during the conduct of the Columbia Suicide Severity Rating Scale (C-SSRS) (21) with concurrence after a study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes"

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

Канада · 1 центр
  • 100 Stokes St — Toronto

Идентификаторы

NCT: NCT07146633 · 167-2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗