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Emotion Regulation DisordersVRsafeNCT07709468

Virtual Reality Exposure Therapy for Emotion Regulation Difficulties in Adolescent Inpatients

A study testing Virtual Reality Exposure Therapy in people with Emotion Regulation Disorders, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Emotion Regulation Disorders
What is being tested?
Virtual Reality Exposure Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSwitzerland
Study dates
15 Sep 2026to Oct 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site
  • Department of Child and Adolescent Psychiatry and Psychotherapy Zurich

    Zurich, 8032

Other trials in Switzerland

About this study

Official title: 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:

Read more

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.

Read the detailed description

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.

Being tested
Virtual Reality Exposure Therapy
Keywords
Virtual Reality, Virtual Reality Exposure Therapy, Emotion Regulation, Adolescents, Child and Adolescent Psychiatry, Inpatient Psychiatry, Anxiety Disorders, Social Anxiety, Sensory Sensitivity / Sensory Over-Responsivity
Medical subject headings
Emotional Regulation, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality Exposure TherapyDevice

    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.

Study groups in NCT07709468
Study groupRoleWhat they receive
Personalized VR exposure therapy in addition to treatment as usualExperimentalParticipants 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.
Receives: Device: Virtual Reality Exposure Therapy
Treatment as UsualNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Questionnaire-based measure assessing emotion regulation skills

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks

  2. Questionnaire-based measure assessing sensory responsivity

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks

Secondary outcomes (12)
  1. Change in Social Responsiveness Scale, Second Edition Total Raw Score From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

  2. Change in Adolescent Dissociative Experiences Scale II Mean Total Score From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

  3. Change in Child Behavior Checklist Total Problems Raw Score From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

  4. Change in Youth Self-Report Total Problems Raw Score From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

  5. Change in Strengths and Difficulties Questionnaire Total Difficulties Score From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

  6. Change in Extreme Demand Avoidance Questionnaire Total Score From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

  7. Change in Camouflaging Autistic Traits Questionnaire Total Score From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

  8. Change in Social Phobia and Anxiety Inventory for Children Total Score From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

  9. Change in Multidimensional Assessment of Interoceptive Awareness, Version 2 Subscale Scores From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

  10. Change in Speech-in-Noise Perception Accuracy From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

  11. Change in Differential Threat-Expectancy Ratings During Fear Extinction From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

  12. Change in Rule-Inference Accuracy on the Object Manipulation Task From Baseline to Post-intervention

    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.

    Measured: From enrollment to the end of treatment at 5-8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completionJul 2030 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07709468
Sponsor's protocol ID
VRsafe-2026-00387
Acronym
VRsafe
Status last verified
Sep 2026
First submitted
7 Jul 2026
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Exposure Therapy in people with Emotion Regulation Disorders, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Questionnaire-based measure assessing emotion regulation skills (time frame: From enrollment to the end of treatment at 5-8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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