Virtual Reality Exposure Therapy for Emotion Regulation Difficulties in Adolescent Inpatients (VRsafe)
Investigating the Efficacy of a Virtual Reality Exposure Therapy Intervention Targeting Emotion Regulation Difficulties in Adolescent Inpatients
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Zurich, Švýcarsko, 8032
- Department of Child and Adolescent Psychiatry and Psychotherapy Zurich
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Written informed consent/assent.
- Age 11-18 years.
- Intelligence Quotient (IQ) ≥ 85.
- Ability and willingness to participate in VR procedures, behavioral tasks, and questionnaires.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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 intervention is delivered several times a week throughout the inpatient stay by trained therapists.
The VR intervention is intended to improve emotion regulation by providing repeated, controlled exposure to clinically relevant situations within a safe and structured therapeutic environment.
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Questionnaire-based measure assessing emotion regulation skills
Časové okno: From enrollment to the end of treatment at 5-8 weeks
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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.
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From enrollment to the end of treatment at 5-8 weeks
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Questionnaire-based measure assessing sensory responsivity
Časové okno: From enrollment to the end of treatment at 5-8 weeks
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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.
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From enrollment to the end of treatment at 5-8 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Social Responsiveness Scale, Second Edition Total Raw Score From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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The Social Responsiveness Scale, Second Edition (SRS-2) is a 65-item caregiver-report questionnaire assessing social-communication difficulties and restricted or repetitive behaviours.
Items are rated from 0 to 3 and summed to produce a total raw score ranging from 0 to 195.
Higher scores indicate greater impairment in social responsiveness and therefore a worse outcome.
Change is calculated as the post-intervention score minus the baseline score; negative values indicate improvement.
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From enrollment to the end of treatment at 5-8 weeks.
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Change in Adolescent Dissociative Experiences Scale II Mean Total Score From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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The Adolescent Dissociative Experiences Scale II (A-DES-II) is a 30-item self-report questionnaire assessing dissociative experiences.
Each item is rated from 0 ("never") to 10 ("always").
The mean total score is calculated as the average of all items and ranges from 0 to 10. Higher scores indicate more frequent dissociative experiences and therefore a worse outcome.
Change is calculated as the post-intervention score minus the baseline score; negative values indicate improvement.
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From enrollment to the end of treatment at 5-8 weeks.
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Change in Child Behavior Checklist Total Problems Raw Score From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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The Child Behavior Checklist for Ages 6-18 (CBCL/6-18) is a caregiver-report questionnaire assessing emotional and behavioural problems.
The Total Problems raw score is calculated by summing the scored problem items and ranges from 0 to 236.
Higher scores indicate greater overall emotional and behavioural difficulties and therefore a worse outcome.
Change is calculated as the post-intervention score minus the baseline score; negative values indicate improvement.
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From enrollment to the end of treatment at 5-8 weeks.
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Change in Youth Self-Report Total Problems Raw Score From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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The Youth Self-Report for Ages 11-18 (YSR/11-18) is a 112-item self-report questionnaire assessing emotional and behavioural problems.
Items are rated from 0 ("not true") to 2 ("very true or often true").
The Total Problems raw score ranges from 0 to 224.
Higher scores indicate greater overall emotional and behavioural difficulties and therefore a worse outcome.
Change is calculated as the post-intervention score minus the baseline score; negative values indicate improvement.
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From enrollment to the end of treatment at 5-8 weeks.
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Change in Strengths and Difficulties Questionnaire Total Difficulties Score From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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The Strengths and Difficulties Questionnaire (SDQ) is a 25-item caregiver-report questionnaire assessing emotional symptoms, conduct problems, hyperactivity/inattention, peer problems, and prosocial behaviour.
The Total Difficulties score is calculated by summing the Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, and Peer Problems subscales.
Scores range from 0 to 40.
Higher scores indicate greater emotional and behavioural difficulties and therefore a worse outcome.
Change is calculated as the post-intervention score minus the baseline score; negative values indicate improvement.
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From enrollment to the end of treatment at 5-8 weeks.
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Change in Extreme Demand Avoidance Questionnaire Total Score From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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The Extreme Demand Avoidance Questionnaire (EDA-Q) is a 26-item caregiver-report questionnaire assessing demand-avoidant behaviours, need for control, emotional reactivity to perceived demands, and related behavioural characteristics.
Items are rated from 0 to 3 and summed to produce a total score ranging from 0 to 78.
Higher scores indicate more pronounced demand-avoidant behavioural characteristics and therefore a worse outcome.
Change is calculated as the post-intervention score minus the baseline score; negative values indicate improvement.
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From enrollment to the end of treatment at 5-8 weeks.
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Change in Camouflaging Autistic Traits Questionnaire Total Score From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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The Camouflaging Autistic Traits Questionnaire (CAT-Q) is a 25-item self-report questionnaire assessing social camouflaging strategies, including compensation, masking, and assimilation.
Items are rated from 1 to 7 and summed to produce a total score ranging from 25 to 175.
Higher scores indicate more frequent use of camouflaging strategies and are interpreted as a less favourable outcome in this study.
Change is calculated as the post-intervention score minus the baseline score; negative values indicate a reduction in camouflaging.
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From enrollment to the end of treatment at 5-8 weeks.
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Change in Social Phobia and Anxiety Inventory for Children Total Score From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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The Sozialphobie und -angstinventar für Kinder (SPAIK; Social Phobia and Anxiety Inventory for Children) is a self-report questionnaire assessing cognitive, somatic, and behavioural symptoms of social anxiety.
Responses are rated from 0 ("never or rarely") to 2 ("mostly or always").
The total score ranges from 0 to 52.
Higher scores indicate greater social-anxiety symptom severity and therefore a worse outcome.
Change is calculated as the post-intervention score minus the baseline score; negative values indicate improvement.
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From enrollment to the end of treatment at 5-8 weeks.
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Change in Multidimensional Assessment of Interoceptive Awareness, Version 2 Subscale Scores From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) is a 37-item self-report questionnaire assessing the awareness, interpretation, and regulation of internal bodily sensations.
It comprises eight subscales: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting.
Items are rated from 0 ("never") to 5 ("always"), and each subscale is calculated as the mean of its respective items, producing scores ranging from 0 to 5. Higher scores generally indicate more adaptive interoceptive awareness and are interpreted as a better outcome.
Change is calculated as the post-intervention score minus the baseline score; positive values indicate improvement.
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From enrollment to the end of treatment at 5-8 weeks.
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Change in Speech-in-Noise Perception Accuracy From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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Speech-in-noise perception is assessed using a computerised task in which participants listen to short sentences presented with auditory noise or competing speech and identify the corresponding number-colour combination.
Performance is calculated as the percentage of correctly identified combinations across trials, ranging from 0% to 100%.
Higher percentages indicate better speech perception and functional performance under sensory load and are interpreted as a better outcome.
Change is calculated as post-intervention accuracy minus baseline accuracy; positive values indicate improvement.
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From enrollment to the end of treatment at 5-8 weeks.
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Change in Differential Threat-Expectancy Ratings During Fear Extinction From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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Fear learning and extinction are assessed using a computerised conditioning task involving a conditioned threat stimulus (CS+) that is paired with an aversive auditory stimulus during acquisition and a safety stimulus (CS-) that is never paired with the aversive stimulus.
Participants rate the expected likelihood of the aversive stimulus following each conditioned stimulus.
A differential threat-expectancy score is calculated by subtracting the expectancy rating for the CS- from the expectancy rating for the CS+.
Higher positive scores indicate stronger differential threat expectancy.
A greater reduction in the differential score during extinction indicates more effective safety updating and is interpreted as a better outcome.
Change is calculated by comparing the task-derived differential expectancy measure at baseline and post-intervention.
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From enrollment to the end of treatment at 5-8 weeks.
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Change in Rule-Inference Accuracy on the Object Manipulation Task From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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Learning under uncertainty and adaptive rule inference are assessed using the Object Manipulation Task.
Participants explore and manipulate virtual objects and receive positive or negative feedback based on their actions.
Through repeated trials, participants must infer the hidden rules governing successful performance.
Rule-inference accuracy is calculated as the percentage of actions that are consistent with the correct hidden rule, ranging from 0% to 100%.
Higher percentages indicate more accurate rule inference, more efficient learning, and better behavioural adaptation and are interpreted as a better outcome.
Change is calculated as post-intervention accuracy minus baseline accuracy; positive values indicate improvement.
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From enrollment to the end of treatment at 5-8 weeks.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Speech- and Language-Based Markers Derived From the Emotion Expression Interview From Baseline to Post-intervention
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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The Emotion Expression Interview is a structured, approximately 15-minute audio-recorded assessment designed to elicit speech relating to emotional processing and emotion regulation.
The interview includes neutral speech, sentence reading, open-ended questions about emotions, descriptions of emotionally salient pictures, and sentence-completion prompts.
Exploratory measures derived from the recordings include content-based indicators of emotional clarity, emotional insight, and articulated regulation strategies, as well as speech- and language-based features such as pitch, intensity, speech rate, lexical diversity, syntactic complexity, and discourse-level organisation.
The measures have different units and ranges, and higher values do not uniformly indicate a better or worse outcome.
Changes in the prespecified features from baseline to post-intervention will be examined exploratorily.
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From enrollment to the end of treatment at 5-8 weeks.
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Mean Heart Rate During Virtual Reality Exposure Across the Treatment Period
Časové okno: From enrollment to the end of treatment at 5-8 weeks.
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Heart rate is recorded continuously during virtual reality exposure sessions using a Polar H10 heart-rate sensor.
Mean heart rate is calculated in beats per minute for each session and used as an exploratory indicator of autonomic arousal during exposure.
Higher values indicate greater physiological arousal but are not inherently interpreted as a better or worse outcome.
Changes in mean heart rate across treatment sessions and associations with intervention progress and symptom change will be examined exploratorily.
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From enrollment to the end of treatment at 5-8 weeks.
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Sandra Baltensperger, MA, Psychiatric University Hospital, Zurich
- Studijní židle: Susanne Walitza, Prof. Dr., Psychiatric University Hospital, Zurich
- Ředitel studie: Maya Schneebeli, Dr. sc. nat., Psychiatric University Hospital, Zurich
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- VRsafe-2026-00387
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