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Набор скоро начнётся NCT06788678

A Randomized Controlled Trial of a Web-Based Moral Elevation Intervention for Veterans With PTSD

Без фазы С лечением Posttraumatic Stress Disorder

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: MOVED, Supportive Care Control.
Кому может быть актуально
Состояния в реестре: Posttraumatic Stress Disorder. 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 →

Обзор

Despite the availability of evidence-based treatments for PTSD, there are many challenges to successful trauma recovery for Veterans including difficulties starting and completing these treatments and gaps in fully addressing additional important treatment targets including lower social functioning and quality of life. Alternative, stand-alone treatment options that address a range of outcomes and can be easily accessed are needed to expand the reach of PTSD treatment to Veterans. One way to address this need is with a positive psychology intervention called MOVED, which has shown promise in a prior pilot study. MOVED is a web-based, self-guided intervention (8 sessions, 4 weeks) that uses moral elevation-feeling inspired by others' virtuous actions. This clinical trial will test if MOVED leads to decreased PTSD symptoms and increased social functioning and quality of life compared to a generic supportive treatment that does not focus on moral elevation. Results will help determine if MOVED is a useful alternative approach to target trauma recovery among Veterans with PTSD.

Подробное описание

Poor treatment engagement and retention with evidence-based practices (EBPs) are significant problems for Veterans with posttraumatic stress disorder (PTSD). Additionally, Veterans with PTSD also face significant issues with impaired social functioning and diminished quality of life; however, research suggests EBPs may not full address these other important treatment targets despite their ability to reduce PTSD symptoms. These limitations showcase how difficult it is to successfully treat PTSD and highlight the need for novel, stand-alone approaches as alternatives to current treatments that can further facilitate trauma recovery. Accessible and easily disseminated treatments are needed to target ongoing concerns for Veterans including PTSD symptoms, lower QOL, and poor social functioning. One approach that is well-suited to target these issues is a positive psychology-based intervention that focuses on eliciting moral elevation and its benefits. Moral elevation is a positive, emotional state of feeling inspired or moved by witnessing others' virtuous actions, which leads to greater social engagement and self-improvement motives. Moral Elevation Online Intervention for Veterans Experiencing Distress (MOVED) was previously developed as a web-based, self-guided intervention (8 sessions; 4 weeks) and piloted with a sample of Veterans experiencing significant PTSD symptoms and moral injury-related distress. Results from the VA funded pilot trial suggested MOVED was highly feasible and acceptable by Veterans, it demonstrated high levels of treatment engagement, and Veterans reported positive treatment outcomes including large decreases in PTSD symptoms and medium increases in quality of life. Given the promising findings from the MOVED pilot trial, the goal of this proposed study is to proceed with the next phase of treatment development for MOVED by conducting a powered efficacy trial with a sample of Veterans diagnosed with PTSD for at least one year. Following recent adaptations to MOVED that were informed by Veteran feedback from the pilot trial and with input from key stakeholders (researchers, clinicians, and Veterans with PTSD), a refined version of MOVED will be examined with a randomized controlled trial (RCT). This RCT will test the efficacy of MOVED compared to a supportive care control treatment in decreasing PTSD symptom severity, increasing social functioning, and increasing quality of life. The targeted sample will include 250 Veterans who have a PTSD diagnosis for at least one year. Eligible participants will be randomized to the MOVED condition or a supportive care control condition. Both interventions will be self-guided, web-based, and will include 8 sessions lasting 4 weeks. The supportive care control treatment will be a present-centered, nondirective intervention that aims to control for the nonspecific therapeutic effects of supportive care, whereas MOVED will focus on eliciting experiences of moral elevation, guided reflection of those experiences, and facilitating the pursuit of weekly behavioral goals related to experiences of elevation. All participants in both conditions will complete clinician-administered interviews and self-report measures to assess outcomes at baseline, posttreatment, 3-month, and 6-month follow-up. Additionally, potential mechanisms of action on treatment outcomes will be assessed at each session including experiences of moral elevation and treatment adherence. Results from this study will indicate whether MOVED is a viable treatment that can reduce PTSD symptoms, boost quality of life, and enhance social functioning; thus, expanding the number of treatment options available for PTSD care.

Вмешательства

  • Поведенческое MOVED
    MOVED includes 8 self-guided, web-based sessions administered over 4 weeks. Web-based sessions include 3 core components: (1) elicit moral elevation, (2) engage in reflection about moral elevation response, and (3) set a behavioral goal that is inspired by the moral elevation exercise.
  • Другое Supportive Care Control
    A present-centered, nondirective intervention that aims to control for the nonspecific therapeutic effects of supportive care. In this case, the effects of engaging in regular web-based sessions that convey information about PTSD symptoms. Sessions will include psychoeducation materials about PTSD symptoms, functioning, and resources for dealing with related stressors. Key components of MOVED will be strictly excluded.

Первичные конечные точки

  • Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [Срок оценки: Follow-up assessments at posttreatment, 3-months, and 6-months.]
  • World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) [Срок оценки: Follow-up assessments at posttreatment, 3-months, and 6-months.]
  • World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [Срок оценки: Follow-up assessments at posttreatment, 3-months, and 6-months.]
Вторичные конечные точки (5)
  • PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: Follow-up assessments at posttreatment, 3-months, and 6-months.]
  • Moral Injury and Distress Scale (MIDS) [Срок оценки: Follow-up assessments at posttreatment, 3-months, and 6-months.]
  • Engagement with Beauty Scale (EBS) - Moral Beauty Subscale [Срок оценки: Follow-up assessments at posttreatment, 3-months, and 6-months.]
  • Purpose in Life - Short Form (PIL-SF) [Срок оценки: Follow-up assessments at posttreatment, 3-months, and 6-months.]
  • Posttraumatic Growth Inventory (PTGI) [Срок оценки: Follow-up assessments at posttreatment, 3-months, and 6-months.]

Критерии участия

Критерии включения

  • Enrolled in a VISN 17 health care system
  • English-speaking and able to provide written informed consent
  • Willingness to complete study procedures and be randomized
  • Internet access and an electronic device to complete the web-based sessions
  • Current diagnosis of PTSD based on the CAPS-5
  • History of PTSD diagnosis for at least 1 year

Критерии исключения

  • History of severe traumatic brain injury indicated by medical record review and the Ohio State Traumatic Brain Injury Identification Method (OSU TBI-ID)
  • Current psychosis or mania as indicated by medical record review and the Mini International Neuropsychiatric Interview (MINI)
  • Current suicide risk based on the Beck Depression Inventory-II (BDI-II)
  • Currently enrolled and actively participating in a trauma-focused treatment including:
  • Cognitive Processing Therapy
  • Prolonged Exposure
  • Eye Movement Desensitization Reprocessing

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
  • Central Texas Veterans Health Care System, Temple, TX — Temple

Идентификаторы

NCT: NCT06788678 · D5081-R

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗