Virtual Reality Exposure Therapy for Emotion Regulation Difficulties in Adolescent Inpatients

NCT07709468 | Not Yet Recruiting

• 1 other identifier: VRsafe-2026-00387
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Emotion Regulation Disorders

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

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (12)

• 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.

Other Outcomes (2)

• Change in Speech- and Language-Based Markers Derived From the Emotion Expression Interview From Baseline to Post-intervention

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

• Mean Heart Rate During Virtual Reality Exposure Across the Treatment Period

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

Study Arms (2)

Personalized VR exposure therapy in addition to treatment as usual

EXPERIMENTAL

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.

Device: Virtual Reality Exposure Therapy

Treatment as Usual

NO INTERVENTION

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.

Interventions

Virtual Reality Exposure Therapy DEVICE

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.

Personalized VR exposure therapy in addition to treatment as usual

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Psychiatric University Hospital, Zurich: lead

MeSH Terms

Conditions

Emotional Regulation; Anxiety Disorders

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): August 4, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-07