Actively Recruiting

Phase Not Applicable
Age: 12Years - 16Years
All Genders
NCT06379633

Virtual Reality Exposure for Socially Anxious Adolescents

Led by KU Leuven · Updated on 2024-04-23

120

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

Sponsors

K

KU Leuven

Lead Sponsor

U

Utrecht University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Overall in this project, the primary goal is to evaluate the efficacy of virtual reality exposure (VRE) for adolescents with elevated social anxiety using a three-arm randomized controlled trial: (1) virtual reality exposure (VRE); (2) in vivo exposure (IVE); and (3) waitlist (WL) - the control condition. It is predicted that both VRE and IVE will be more successful in decreasing social anxiety symptoms than the WL condition at post-assessment and that VRE will be as effective as in vivo in reducing social anxiety symptoms. Furthermore, it is expected that there will be no difference between the two active conditions in the long term (at 3- months \& 6-months follow up). Similar results are expected in the secondary outcome measures, intended to capture the participants' general well-being. Moreover, the study has the following (secondary) objectives: * To elucidate potential working mechanisms of VRE and IVE * To identify predictors of adolescents' response to VRE and IVE * To assess to what extent adolescents accept VRE and IVE and how they experience it

CONDITIONS

Official Title

Virtual Reality Exposure for Socially Anxious Adolescents

Who Can Participate

Age: 12Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Elevated levels of social anxiety (Social Phobia Inventory score ≥ 19)
  • Fluent in Dutch
  • Aged 12 to 16 years
Not Eligible

You will not qualify if you...

  • Severe social anxiety disorder
  • Severe depression
  • Psychotic symptoms
  • Severe suicidal thoughts or severe self-harm
  • Severe substance use
  • Current or recent benzodiazepine use or change in psychoactive medication
  • Autism spectrum disorder diagnosis
  • Current ongoing psychological treatment or waitlist for anxiety or depression
  • Other urgent psychiatric conditions or mismatch with offered training
  • Exposure therapy for social anxiety disorder in past 2 years
  • Another person from the same household participating
  • History of extreme or severe motion sickness or severe symptoms during 3D movies
  • Stereoscopic vision or balance problems affecting VR experience
  • History of seizures, seizure disorder, or epilepsy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Psychological Institute (PSI) of KU Leuven

Leuven, Belgium, 3000 Leuven

Actively Recruiting

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Research Team

E

Elizabeth S. Uduwa-vidanalage, MSc

CONTACT

J

Jella De Lee, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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