Using Virtual Reality to Treat Social Anxiety in Autistic Adolescents

NCT ID: NCT04301141

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder Social Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality Assisted Cognitive Behavioural Therapy

Between 8 to 20 individual in-person sessions of VR-assisted CBT will be delivered on a weekly basis by NHS therapists who are trained in delivering CBT to this patient group.

Group Type EXPERIMENTAL

Virtual Reality Assisted Cognitive Behavioural Therapy

Intervention Type OTHER

The intervention will be delivered in NHS services and will involve using VR to assist the delivery of conventional CBT for the treatment of social anxiety in autistic adolescents. Social situations that are commonly anxiety-evoking for this patient group will be simulated in VR and used for exposure (a typical component of CBT for social anxiety). Therapists will use a modular approach involving optional modules such as psychoeducation on anxiety in the context of ASD, managing expectations of outcome and emotional literacy training. Essential modules include rapport building, introducing the use and purpose of VR, and exposure (incorporating VR). Because CBT is delivered in routine clinical practice, the VR exposure sessions will be the main subject of interest.

Interventions

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Virtual Reality Assisted Cognitive Behavioural Therapy

The intervention will be delivered in NHS services and will involve using VR to assist the delivery of conventional CBT for the treatment of social anxiety in autistic adolescents. Social situations that are commonly anxiety-evoking for this patient group will be simulated in VR and used for exposure (a typical component of CBT for social anxiety). Therapists will use a modular approach involving optional modules such as psychoeducation on anxiety in the context of ASD, managing expectations of outcome and emotional literacy training. Essential modules include rapport building, introducing the use and purpose of VR, and exposure (incorporating VR). Because CBT is delivered in routine clinical practice, the VR exposure sessions will be the main subject of interest.

Intervention Type OTHER

Other Intervention Names

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VR-CBT

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucia Valmaggia, Dr

Role: PRINCIPAL_INVESTIGATOR

South London and Maudsley NHS Foundation Trust; King's College London

Emily Simonoff, Prof

Role: PRINCIPAL_INVESTIGATOR

King's College London; South London and Maudsley NHS Foundation Trust

Lauren Taylor, Dr

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

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St Thomas Hospital, Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

King's College London

London, , United Kingdom

Site Status

Maudsley Hospital, South London and Maudsley NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Lucia Valmaggia, Dr

Role: CONTACT

02078485003

Lucy Adams, MSc

Role: CONTACT

0207 848 5717

Facility Contacts

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Lauren Taylor, Dr

Role: primary

0207 188 7188

Lucy Adams, MSc

Role: backup

0207 848 5717

Lucia Valmaggia, Dr

Role: primary

02078485003

Lucy Adams, MSc

Role: backup

0207 848 5717

Emily Simonoff, Prof.

Role: primary

02078485312

Lucy Adams, MSc

Role: backup

0207 848 5717

Other Identifiers

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0c Valmaggia

Identifier Type: -

Identifier Source: org_study_id

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