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Набор скоро начнётся NCT07709468

Virtual Reality Exposure Therapy for Emotion Regulation Difficulties in Adolescent Inpatients

Без фазы С лечением Emotion Regulation 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: Virtual Reality Exposure Therapy.
Кому может быть актуально
Состояния в реестре: Emotion Regulation Disorders. Базовые параметры: 11 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Investigating the Efficacy of a Virtual Reality Exposure Therapy Intervention Targeting Emotion Regulation Difficulties in Adolescent Inpatients

Обзор

The goal of this clinical trial is to evaluate whether a therapist-guided virtual reality (VR)-based intervention can improve emotion regulation in adolescents receiving inpatient psychiatric treatment. The study will also assess the feasibility, acceptability, and safety of the intervention, as well as explore factors that may predict treatment response. The main questions it aims to answer are: Does the VR-based intervention improve emotion regulation compared with a VR relaxation control intervention? Does the intervention reduce sensory sensitivities, anxiety, and related psychological symptoms? Which behavioral, physiological, and speech-based measures are associated with treatment response? Researchers will compare a personalized VR exposure intervention with a VR relaxation control intervention. Both groups will receive treatment as usual during their inpatient stay. Participants will: Be randomly assigned to either the VR exposure or the VR relaxation group. Complete questionnaires, behavioral tasks, and clinical assessments before and after the intervention, with a follow-up assessment approximately three months later. Participate in weekly therapist-guided VR sessions throughout their inpatient treatment. Complete additional assessments including speech recordings and standardized behavioral tasks to investigate predictors and mechanisms of treatment response. Throughout the study, participants will be monitored for adverse events and tolerability of the VR intervention.

Подробное описание

This study is a prospective, monocentric, randomized controlled trial evaluating a therapist-guided virtual reality (VR)-based intervention designed to improve emotion regulation in adolescents receiving inpatient psychiatric treatment. Participants will be randomly assigned in a 2:1 ratio to either a personalized VR exposure intervention or a VR relaxation control intervention. Both groups will continue to receive treatment as usual throughout the study period.

The intervention has been developed as an adjunct to standard inpatient care and is tailored to each participant's individual emotional and environmental triggers. Prior to treatment, therapists identify situations that are personally relevant and emotionally challenging for each participant. These situations are then translated into individualized VR session templates based on a standardized library of immersive 360° environments. Throughout the intervention, therapists gradually adjust the intensity and complexity of the exposure according to the participant's progress while maintaining a structured therapeutic framework.

Participants assigned to the control group receive therapist-guided VR relaxation sessions of comparable frequency and duration using immersive natural environments. The control intervention is designed to match the experimental condition with respect to therapist contact, VR exposure, and session length while omitting exposure-based therapeutic components.

Study assessments are conducted at baseline before the intervention, immediately after completion of the intervention, and approximately three months after discharge. Assessments include self-report and caregiver-report questionnaires, standardized behavioral tasks, clinical ratings, and speech-based assessments. In addition to evaluating changes in emotion regulation and related psychological functioning, the study investigates potential predictors and mechanisms of treatment response. These include behavioral performance, physiological responses, eye-tracking measures, and speech characteristics collected during standardized assessment procedures.

Physiological and behavioral data are recorded using non-invasive sensors integrated into the VR system and additional research equipment. Depending on the assessment, these may include heart rate, eye-tracking, head and controller movement, and VR interaction data. Speech recordings obtained during standardized interviews and selected VR scenarios will be analyzed for linguistic and acoustic characteristics. Multimodal data from the same assessment session can be linked using pseudonymized study identifiers and timestamps to investigate relationships between behavioral, physiological, and speech-based measures.

The study will also evaluate the feasibility, acceptability, and safety of implementing personalized VR interventions within an inpatient child and adolescent psychiatric setting. Adverse events, tolerability, session completion, and participant adherence will be documented throughout the intervention. The findings are intended to inform the future implementation and optimization of individualized VR-assisted psychological interventions for adolescents with emotion regulation difficulties across a range of psychiatric diagnoses.

Вмешательства

  • Устройство Virtual Reality Exposure Therapy
    The intervention consists of therapist-guided, individualized virtual reality (VR) exposure sessions delivered as an adjunct to treatment as usual during inpatient psychiatric care. Personalized VR scenarios are created using standardized 360° environments based on each participant's individual emotional and environmental triggers. Sessions include graded exposure, with therapists adapting the intensity and complexity of the scenarios according to treatment progress and individual needs. The int

Первичные конечные точки

  • Questionnaire-based measure assessing emotion regulation skills [Срок оценки: From enrollment to the end of treatment at 5-8 weeks]
  • Questionnaire-based measure assessing sensory responsivity [Срок оценки: From enrollment to the end of treatment at 5-8 weeks]
Вторичные конечные точки (12)
  • Change in Social Responsiveness Scale, Second Edition Total Raw Score From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]
  • Change in Adolescent Dissociative Experiences Scale II Mean Total Score From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]
  • Change in Child Behavior Checklist Total Problems Raw Score From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]
  • Change in Youth Self-Report Total Problems Raw Score From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]
  • Change in Strengths and Difficulties Questionnaire Total Difficulties Score From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]
  • Change in Extreme Demand Avoidance Questionnaire Total Score From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]
  • Change in Camouflaging Autistic Traits Questionnaire Total Score From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]
  • Change in Social Phobia and Anxiety Inventory for Children Total Score From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]
  • Change in Multidimensional Assessment of Interoceptive Awareness, Version 2 Subscale Scores From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]
  • Change in Speech-in-Noise Perception Accuracy From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]
  • Change in Differential Threat-Expectancy Ratings During Fear Extinction From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]
  • Change in Rule-Inference Accuracy on the Object Manipulation Task From Baseline to Post-intervention [Срок оценки: From enrollment to the end of treatment at 5-8 weeks.]

Критерии участия

Критерии включения

  • Written informed consent/assent.
  • Age 11-18 years.
  • Intelligence Quotient (IQ) ≥ 85.
  • Ability and willingness to participate in VR procedures, behavioral tasks, and questionnaires.

Критерии исключения

  • Major somatic or cardiovascular conditions.
  • Aggressive behavior posing a risk to self or others.
  • Participation in another clinical investigation within the previous 30 days.
  • Severe motion sickness or vestibular disorders.
  • Inability to comply with study procedures.
  • Discharge from the inpatient setting before completing the minimum intervention duration.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07709468 · VRsafe-2026-00387

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗