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ClinicalTrials.gov ID

NCT04301141

Lead Sponsor

King's College LondonOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

5Estimated

Last Update Posted

Sep 9, 2020Actual

Start Date

Jan 2021Estimated

Primary Completion Date

Sep 2021Estimated

Completion Date

Sep 2021Estimated

Official Title

Using Virtual Reality Assisted Therapy for Social Anxiety in Adolescents With Autism Spectrum Disorder: A Case Series

Brief Summary

This study will test the feasibility and acceptability of virtual reality assisted cognitive behavioural therapy for the treatment of social anxiety in autistic adolescents. Five adolescents will receive the intervention and a parent/caregiver of each adolescent will be asked to act as informants on some questionnaires and interviews.

Detailed Description

Difficulties interacting with others in social situations is a core characteristic of autism spectrum disorder (ASD). These difficulties are intensified by social anxiety - commonly experienced in autistic adolescents. A promising psychological treatment is cognitive behavioural therapy (CBT), but there are constraints in its use for the autistic population. For example, CBT requires patients to imagine being in a social situation that would cause anxiety, but autistic people often experience difficulties with imagination. The use of virtual reality (VR) in CBT may help to lessen such constraints. VR uses 3D computer-generated visual environments displayed through a head-mounted display. The images are synchronised to the movements of the user such that they experience feeling immersed in the virtual scene. The virtual scene can involve social scenarios, making it an ideal tool for eliciting social anxiety in the treatment setting. The investigators can see if these virtual scenarios are indeed eliciting social anxiety by recording physiological responses (e.g. heart rate) in parallel with patients' anxiety ratings during exposure. This is important for CBT to be effective.

This study will test the feasibility and acceptability of VR-assisted CBT, combined with the use of physiological measurements, in autistic adolescents experiencing social anxiety. The therapy will typically consist of 8-20 weekly sessions and will be delivered by clinical psychologists in local mental health services. Conventional outcome measures will be used and feedback from youth and their parents/caregivers will be requested. The results of this study may lead to modification of the treatment and research methods. They will inform a later pilot randomised controlled trial.

• Autism Spectrum Disorder
• Social Anxiety

• Virtual Reality Assisted Cognitive Behavioural Therapy

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

Participants will be included at screening if:

• Aged between 13 and 18 years
• Clinically diagnosed with ASD by a neurodevelopmental clinician
• Experiencing anxiety in social situations that is impairing daily functioning as determined by clinicians
• Deemed suitable by the clinical team for the intervention based on factors such as sufficient verbal ability, desire to participate, willingness to undertake exposure-based activities, and no current/active suicidal plans.
• Able to speak and understand English fluently
• Patient and parents/caregivers agree to CBT

Exclusion Criteria:

Participants will be excluded at screening if:

• Diagnosed with photosensitive epilepsy
• Receiving concurrent psychological therapy
• Immediate plans are in-place to change their psychopharmacological medication regimen

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

King's College LondonOTHER

Collaborators

South London and Maudsley NHS Foundation TrustOTHER

National Institute for Health Research, United KingdomOTHER_GOV

Guy's and St Thomas' NHS Foundation TrustOTHER

lucia.valmaggia@kcl.ac.uk02078485003