Using Virtual Reality to Treat Social Anxiety in Autistic Adolescents

NCT04301141 | Unknown

• 1 other identifier: 0c Valmaggia
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

Autism Spectrum Disorder; Social Anxiety

Keywords

social phobia; anxiety

Outcome Measures

Primary Outcomes (1)

• VR session completion rate.

  This will be indicated by the proportion of the patients who commenced the VR component that completed it. Completion is defined as 75% attendance of the total VR exposure sessions recommended by the therapist. Not all therapy sessions involve VR exposure.

  Through study completion, anticipated duration of 9 months.

Secondary Outcomes (12)

• Rate of participant identification.

  End of recruitment period, maximum duration 7.5 months from study start date.

• Recruitment rate.

  Through study completion, anticipated duration of 9 months.

• Rate of participant retention.

  Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.

• Therapy attendance.

  End of therapy up to 20 weeks.

• Frequency and number of sessions.

  Through study completion, anticipated duration of 9 months.

Other Outcomes (11)

• Autonomic activity marker: electrodermal activity.

  First VR exposure session (up to 19 weeks); Final VR exposure session (up to 20 weeks). Timepoints of the first and final VR exposure session will be decided by the therapist case-by-case, see Assigned Intervention for details.

• Autonomic activity marker: Heart rate

  First VR exposure session (up to 19 weeks); Final VR exposure session (up to 20 weeks). Timepoints of the first and final VR exposure session will be decided by the therapist case-by-case, see Assigned Intervention for details.

• Autonomic activity marker: Heart rate variability (HRV)

  First VR exposure session (up to 19 weeks); Final VR exposure session (up to 20 weeks). Timepoints of the first and final VR exposure session will be decided by the therapist case-by-case, see Assigned Intervention for details.

Study Arms (1)

Virtual Reality Assisted Cognitive Behavioural Therapy

EXPERIMENTAL

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.

Other: Virtual Reality Assisted Cognitive Behavioural Therapy

Interventions

Virtual Reality Assisted Cognitive Behavioural Therapy 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.

Also known as: VR-CBT

Virtual Reality Assisted Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (3)

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

London, SE1 7EH, United Kingdom

Location

King's College London

London, SE5 8AF, United Kingdom

Location

Maudsley Hospital, South London and Maudsley NHS Foundation Trust

London, SE5 8AZ, United Kingdom

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Phobia, Social; Anxiety Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Phobic Disorders

Study Officials

• Lucia Valmaggia, Dr

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

  PRINCIPAL INVESTIGATOR

• Emily Simonoff, Prof

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

  PRINCIPAL INVESTIGATOR

• Lauren Taylor, Dr

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Valmaggia, Dr

CONTACT

02078485003; lucia.valmaggia@kcl.ac.uk

Lucy Adams, MSc

CONTACT

0207 848 5717; lucy.1.adams@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: March 10, 2020
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 9, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)