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Набор по приглашению NCT05987735

Psycho-education Program BLAME-LESS and It's Effect on Traumarelated Shame and Guilt

Без фазы С лечением Trauma

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: BLAME-LESS.
Кому может быть актуально
Состояния в реестре: Trauma. Базовые параметры: 12 лет — 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
Нидерланды
Следующий шаг
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Официальное название

BLAME-LESS STUDY: a Two-arm Randomized Controlled Trial Evaluating the Effects of an Online Psycho-education Program for Adolescents Who Experienced (sexual) Violence.

Обзор

The primary objective of the BLAME-LESS study is to examine the effectiveness of an online psychoeducation program in reducing trauma-related feelings of shame and guilt in adolescents who experienced sexual or physical abuse .

Подробное описание

The study follows a two-arm RCT (n=34). The effects of a brief online psychoeducation program will be compared, with a waiting-list control group. The intervention aims to reduce feelings of trauma-related shame and guilt that adolescents experience regarding their own defense responses during and after (sexual) violence. Assessments take place after screening, at baseline, two weeks after allocation to the intervention or waiting-list, and, only for the waiting-list participants, seven weeks after allocation to the intervention.

Вмешательства

  • Поведенческое BLAME-LESS
    The BLAME-LESS program was designed to educate about common defense responses that may occur during and after (sexual) violence. The main goal of the program is to reduce the feelings of shame and/or guilt related to these responses. The program was created in collaboration with licensed developmental and clinical psychologists with extensive psycho-trauma expertise, young adults who are experienced experts, visual artists, and web designers. The program is offered via a website and consists of

Первичные конечные точки

  • Primary outcome: Changes in Feelings of Shame and Guilt [Срок оценки: The SGATS will be assessed at before treatment (T1 = Week 1), after treatment (T2 = Week 4, T3 = week 7)]
Вторичные конечные точки (4)
  • Secondary outcome: Changes in Posttraumatic Stress Symptoms [Срок оценки: The KJTS will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7).]
  • Secondary outcome: Changes in Depression and Anxiety Symptoms [Срок оценки: The PROMIS will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7)]
  • Secondary outcome: Changes in Posttraumatic Cognition [Срок оценки: The CPTCI will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7)]
  • Secondary outcome: Changes in motivation and disclosure [Срок оценки: The TPEQ will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7)]

Критерии участия

Критерии включения

  • the participant experienced one or more traumatic life events, including (sexual) violence as indicated by the CTSQ;
  • the participant reported one or more feelings of guilt and/or shame on the CERQ (items 1 and/or 10 and/or 19 and/or 28)
  • the participant being fluent in written and spoken Dutch;
  • the participant is motivated and available for a period of seven weeks to engage in the study, including the psychoeducation program BLAME-LESS, and commit to the assessments.

Критерии исключения

  • acute suicidal behavior or suicidal ideations requiring immediate hospitalization;
  • the participant has already read the book that this program is based upon: "Paralyzed with Fear" (In Dutch: Verlamd van Angst, van Minnen 2017), or has been intensively informed otherwise in the past 12 months by a psychologist about common defense responses during and after trauma;
  • Cognitive Impairments (IQ < 70);
  • the participant has a brother or sister in the present study;
  • the participant is already involved in trauma-focused treatment.

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
Открытое
Основная цель
Лечение

Центры проведения

Нидерланды · 1 центр
  • Karakter kinder- en jeugdpsychiatrie — Almelo

Идентификаторы

NCT: NCT05987735 · Ontschuldig

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗