Набор по приглашению NCT07460817

A Brief Intervention for PTSD - BWRT

Без фазы С лечением Post Traumatic 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: BrainWorking Recursive Therapy, Treatment as usual.
Кому может быть актуально: Состояния в реестре: Post Traumatic Stress Disorder. 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: Норвегия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Brief Intervention for PTSD Versus Treatment as Usual: Study Protocol for a Non-inferiority Randomized Controlled Trial

Обзор

The purpose of this study is to investigate if a novel brief intervention for Posttraumatic stress disorder (PTSD) is comparable to other traditional clinical interventions for symptom reduction.

Подробное описание

Background: Although existing treatment methods are effective in alleviating PTSD symptoms, several barriers to care exist, such as waiting lines, avoidant tendencies, shame and stigma, potentially leading to fewer people seeking therapy or premature dropouts. A potential solution to battling these barriers is Brain Working Recursive Therapy (BWRT), a single-session intervention for PTSD. Although not yet subjected to empirical investigation, clinical experiences suggest an often immediate and long-lasting effect following the intervention related to patient's symptomatology and functional abilities.

Methods: The current study protocol outlines a plan to conduct the first non-inferiority randomized controlled trial aimed to explore the efficacy of BWRT compared to treatment as usual (TAU). Eighty-two participants will be allocated at a 1:1 ratio to one of the following treatment conditions: (1) BWRT or (2) treatment as usual. Participants will be compared on several variables, including changes in PTSD symptoms (primary objective), and changes in perceived quality of life, rumination, functional and cognitive ability (secondary objective). Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).

Discussion: Should BWRT prove to be non-inferior to treatment as usual, this brief intervention may be an important contribution to future psychological treatment for PTSD, by making trauma treatment more accessible and battling current barriers to care.

Вмешательства

Поведенческое BrainWorking Recursive Therapy
one session therapy
Поведенческое Treatment as usual
evidence-based therapy

Первичные конечные точки

The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [Срок оценки: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).]

Вторичные конечные точки (4)

The Satisfaction with Life Scale (SWLS) [Срок оценки: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).]
Ruminative Responses Scale (RRS) [Срок оценки: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).]
Work and Social Adjustment Scale (WSAS) [Срок оценки: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).]
Perceived Deficits Questionnaire-Depression, 5-item (PDQ-D5) [Срок оценки: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).]

Критерии участия

Критерии включения

Participants must have experienced at least one traumatic experience throughout their lifetime
Participants must meet the DSM-5 criteria for PTSD, or subthreshold PTSD
The following DSM-5 criteria must be fulfilled:
A (exposure to traumatic stressor),
in addition to three out of four of the following symptom-clusters;
B (intrusion),
C (avoidance),
D (negative alterations in cognitions and mood),
E (alterations in arousal and reactivity)
A marked decline in functioning and symptom persistence for over a month