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Идёт набор NCT07373223

Virtual Reality Schema Therapy Exercises With Parent and Child Modes

Без фазы С лечением Psychiatric 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: VR Schema Therapy Chairwork Exercise.
Кому может быть актуально
Состояния в реестре: Psychiatric Disorders. 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
Нидерланды
Следующий шаг
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Официальное название

VR-STEM: Virtual Reality Schema Therapy Exercises With Parent and Child Modes

Обзор

The goal of this clinical trial is to develop a Virtual Reality version of a Schema Therapy exercise and test its feasibility, acceptability and potential usefulness in people with psychiatric disorders (age 18-65). The main questions the investigators aim to answer are: 1. Are dialogue exercises with virtual reality mode avatars feasible, acceptable and useful? 2. How do patients experience VR schema therapy exercises (in terms of immersion, elicited emotions, therapeutic relationship or subjective efficacy) and are the exercises potentially effective (in terms of schema mode scores, self-criticism, self-compassion and self-esteem)? 3. In case of a potential 'effect', is this moderated by mental imagery ability? The investigators hypothesize that 1) dialogue exercises with virtual reality mode avatars are feasible, ac-ceptable and useful according the Technology Acceptance Model (TAM; Davis, 1989); 2) patients experience high levels of immersion, elicited emotions and subjective efficacy, a strong therapeutic relationship, and show effects on schema mode scores and self-compassion and self-esteem scores; and 3) these effects are moderated by patients' mental imagery ability in such a way that patients with less mental imagery abilities benefit most. The development of the VR version of the exercise will be done in collaboration with patients and therapists. To test its feasibility, acceptability and potential usefulness, participants will be invited to receive one session of the exercise. During this session, they will complete some questionnaires before and after the exercise, and they will be asked about their opinions about and experiences of the exercise.

Вмешательства

  • Поведенческое VR Schema Therapy Chairwork Exercise
    VR Schema Therapy chairwork exercise

Первичные конечные точки

  • Screened and enrolled patients per month [Срок оценки: From start to end of recruitment (+/- 10 months)]
  • Drop-outs [Срок оценки: From start to end of recruitment (+/- 10 months)]
  • Reasons for withdrawal [Срок оценки: From start to end of recruitment (+/- 10 months)]
  • Total and types of adverse events [Срок оценки: From start to end of recruitment (+/- 10 months)]
  • Experienced issues during sessions [Срок оценки: During the 2-hour sessions (From start to end of recruitment [+/- 10 months])]
  • Evaluative questions [Срок оценки: At the end of the 2-hour intervention session (at post-intervention assessment)]
  • Patients qualitative first experiences [Срок оценки: At the end of the 2-hour intervention session, after the post-intervention assessment]
Вторичные конечные точки (5)
  • Momentary Schema Modes Questionnaire (MSMQ) [Срок оценки: At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention)]
  • Visual Analogue Scales [Срок оценки: At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention)]
  • Self-Compassion and self-Criticism Scales (SCCS) [Срок оценки: At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention)]
  • Immersion [Срок оценки: At the end of the 2-hour intervention session (at post-intervention assessment)]
  • Therapeutic relationship [Срок оценки: At the end of the 2-hour intervention session (post-intervention asessment)]

Критерии участия

Критерии включения

  • 18-65 years of age
  • In treatment at a tertiary treatment facility (UCP, UMCG)
  • Whose current psychological distress is related to early life experiences as indicated by a clinician
  • Score of >3 on one of three schema modes on the SMI (Lobbestael et al., 2010)

Критерии исключения

  • Insufficient command of the Dutch language
  • Primary diagnosis of a substance use disorder, or organic brain disease (such as dementia)
  • Unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Нидерланды · 1 центр
  • University Medical Centre Groningen — Groningen

Идентификаторы

NCT: NCT07373223 · 22811

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗