Clinical trial NCT04301141: Using Virtual Reality to Treat Social Anxiety in Autistic Adolescents
Official title: Using Virtual Reality Assisted Therapy for Social Anxiety in Adolescents With Autism Spectrum Disorder: A Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Social Anxiety
Keywords: social phobia
anxiety
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
name: National Institute for Health Research, United Kingdom
name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2020-03-10
Enrollment: 5
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 outcomes:
measure: VR session completion rate.
timeFrame: Through study completion, anticipated duration of 9 months.
Secondary outcomes:
measure: Rate of participant identification.
timeFrame: End of recruitment period, maximum duration 7.5 months from study start date.
measure: Recruitment rate.
timeFrame: Through study completion, anticipated duration of 9 months.
measure: Rate of participant retention.
timeFrame: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
measure: Therapy attendance.
timeFrame: End of therapy up to 20 weeks.
measure: Frequency and number of sessions.
timeFrame: Through study completion, anticipated duration of 9 months.
measure: Adverse effects.
timeFrame: During and immediately after the intervention.
measure: Experience and opinions on the intervention.
timeFrame: End of therapy up to 20 weeks.
measure: Data completion rates.
timeFrame: End of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
measure: Homework compliance.
timeFrame: End of therapy up to 20 weeks.
measure: Change in progress with attaining therapy goals.
timeFrame: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
measure: Change in anxiety (including social anxiety) and depression levels.
timeFrame: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
measure: Change in Global Outcome Ratings of Severity of Illness.
timeFrame: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
Other outcomes:
measure: Autonomic activity marker: electrodermal activity.
timeFrame: 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.
measure: Autonomic activity marker: Heart rate
timeFrame: 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.
measure: Autonomic activity marker: Heart rate variability (HRV)
timeFrame: 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.
measure: Actigraphy: Overall body movement.
timeFrame: 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.
measure: Subjective Units of Distress.
timeFrame: 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
measure: Negative effects from the VR experience.
timeFrame: 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
measure: Sense of presence in the VR environments.
timeFrame: 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
measure: Engagement in the VR environments.
timeFrame: 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
measure: Ecological validity of the VR environments.
timeFrame: 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
measure: Duration of VR exposure.
timeFrame: During the intervention.
measure: The VR environments/scenarios used.
timeFrame: During the intervention.
Locations:
city: London
country: United Kingdom
facility: St Thomas Hospital, Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College London
city: London
country: United Kingdom
facility: Maudsley Hospital, South London and Maudsley NHS Foundation Trust
Study officials:
affiliation: South London and Maudsley NHS Foundation Trust; King's College London
name: Lucia Valmaggia, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London; South London and Maudsley NHS Foundation Trust
name: Emily Simonoff, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Lauren Taylor, Dr
role: PRINCIPAL_INVESTIGATOR
References: