Investigating the Efficacy of a Virtual Reality Exposure Therapy Intervention Targeting Emotion Regulation Difficulties in Adolescent Inpatients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Questionnaire-based measure assessing emotion regulation skills
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent/assent.
- •Age 11-18 years.
- •Intelligence Quotient (IQ) ≥
- •Ability and willingness to participate in VR procedures, behavioral tasks, and questionnaires.
排除标准
- •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.
研究组 & 干预措施
Personalized VR exposure therapy in addition to treatment as usual
Participants receive individualized therapist-guided virtual reality exposure sessions in addition to treatment as usual (TAU) during their inpatient stay. VR scenarios are selected and adapted according to each participant's individual emotional and environmental triggers using standardized 360° environments. Therapists gradually increase the intensity and complexity of exposure across sessions while applying cognitive behavioral therapy principles. Participants also complete all scheduled study assessments before the intervention, after completion of the intervention, and at follow-up.
干预措施: Virtual Reality Exposure Therapy (Device)
Treatment as Usual
Participants receive treatment as usual (TAU) provided as part of routine inpatient psychiatric care. TAU may include individual psychotherapy, group therapy, pharmacological treatment, occupational and recreational therapy, psychoeducation, and other clinical services according to individual treatment needs. Participants complete the same study assessments as the experimental group at baseline, post-intervention, and follow-up but do not receive the study-specific VR intervention.
结局指标
主要结局
Questionnaire-based measure assessing emotion regulation skills
时间窗: From enrollment to the end of treatment at 5-8 weeks
The "Selbsteinschätzung Emotionaler Kompetenzen" (SEK-27; Emotion Regulation Skills Questionnaire) is a 27-item self-report questionnaire assessing adaptive emotion-regulation skills. Items are rated from 0 to 4. The mean total score is calculated as the average of all 27 items and ranges from 0 to 4. Higher scores indicate better emotion-regulation skills. Change is calculated as the post-intervention score minus the baseline score; positive values indicate improvement.
Questionnaire-based measure assessing sensory responsivity
时间窗: From enrollment to the end of treatment at 5-8 weeks
The Children's Glasgow Sensory Questionnaire (C-GSQ) is a 42-item pictorial self-report questionnaire assessing hyper- and hyporeactivity across seven sensory modalities. Items are rated from 0 ("never") to 4 ("always"), yielding a total score ranging from 0 to 168. Higher scores indicate more pronounced sensory-processing differences and therefore a worse outcome. Change is calculated as the post-intervention score minus the baseline score; negative values indicate improvement.
次要结局
- Change in Social Responsiveness Scale, Second Edition Total Raw Score From Baseline to Post-intervention(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(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(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(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(From enrollment to the end of treatment at 5-8 weeks.)
- Change in Extreme Demand Avoidance Questionnaire Total Score From Baseline to Post-intervention(From enrollment to the end of treatment at 5-8 weeks.)
- Change in Camouflaging Autistic Traits Questionnaire Total Score From Baseline to Post-intervention(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(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(From enrollment to the end of treatment at 5-8 weeks.)
- Change in Speech-in-Noise Perception Accuracy From Baseline to Post-intervention(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(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(From enrollment to the end of treatment at 5-8 weeks.)