Using Virtual Reality to Treat Social Anxiety in Autistic Adolescents

Not Applicable

• Conditions: Autism Spectrum Disorder; Social Anxiety
• Interventions: Other: Virtual Reality Assisted Cognitive Behavioural Therapy

• Registration Number: NCT04301141
• Lead Sponsor: King's College London

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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-10
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09
• Study Start: 2021-01
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality Assisted Cognitive Behavioural Therapy	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.

Primary Outcome Measures

Name	Time	Method
VR session completion rate.	Through study completion, anticipated duration of 9 months.	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.

Secondary Outcome Measures

Name	Time	Method
Rate of participant identification.	End of recruitment period, maximum duration 7.5 months from study start date.	Number of patients deemed eligible to partake.
Recruitment rate.	Through study completion, anticipated duration of 9 months.	Proportion of eligible patients successfully recruited (i.e. the proportion of patients approached for whom consent was provided to participate).
Rate of participant retention.	Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.	The proportion of participants completing each stage of the study (i.e. baseline assessments/measures, therapy and therapy measures, and post-treatment assessments/measures).
Therapy attendance.	End of therapy up to 20 weeks.	The proportion of sessions recommended by the therapist that the patient attended.
Frequency and number of sessions.	Through study completion, anticipated duration of 9 months.	The number and frequency of VR-CBT sessions deemed suitable for each patient.
Adverse effects.	During and immediately after the intervention.	This is a 25-item self-report questionnaire. Participants are asked to rate the extent they agree with each statement using a 5-point Likert scale (0 = Not at all; 4 = Very much). Statements refer to their experience of the therapy and whether taking part has caused any distress. Higher scores indicate increased adverse effects.
Change in Global Outcome Ratings of Severity of Illness.	Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.	Measured using the Clinical Global Impression-Improvement Scale (CGI-I; Guy, 1976).; At baseline, the researcher will rate their "impression" of illness severity using baseline qualitative data from the Anxiety Disorders Interview Schedule (ADIS-IV; Albano \& Silverman, 1996) on a 7-point Likert scale (1 = normal, not ill at all; 7 = among the most severely ill patients). The ADIS-IV is a semi-structured clinical interview which will be conducted separately with patients and their parents/caregivers (informants).; The same researcher will compare baseline ADIS-IV data with data obtained from a follow-up (qualitative) interview to rate "improvement". The follow-up interview will be semi-structured, follow a topic guide, and be conducted with the patient and their parent/caregiver (informants) separately. Topics will cover functioning across activities of daily living. "Improvement" will be rated on an 8-point Likert scale (1 = completely recovered; 5 = no change; 8 = very much worse).
Experience and opinions on the intervention.	End of therapy up to 20 weeks.	Qualitative feedback regarding the intervention will be sought from therapists and participants using a semi-structured interview. The interview will follow a topic guide aimed at understanding opinions on helpful aspects of the therapy, suggestions for improvement, and the perceived level of social presence (i.e. the subjective experience of being with the non-player characters) in the VR environments. Feedback will be summarised.
Data completion rates.	End of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.	Proportion of questionnaires, assessments and interview appointments completed.
Homework compliance.	End of therapy up to 20 weeks.	The proportion of homework assignments completed (as indicated by the therapist).
Change in progress with attaining therapy goals.	Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.	This will be measured using Goal Attainment Scaling (GAS). Goals are agreed at the start of therapy. Initially patients rate the importance, difficulty, and how they are functioning at baseline, for each goal. After therapy patients indicate whether the goal has been achieved and rate the outcome (e.g. +2 better than expected, -2 worse than expected).
Change in anxiety (including social anxiety) and depression levels.	Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.	Measured using the Revised Children's Anxiety and Depression Scale (and Subscales) (RCADS; Chorpita et al. 2000). This is a 47-item self-report questionnaire. Both youth (suitable for ages 8 to 18 years) and parental/caregiver forms will be administered. Participants rate each item using a 4-point Likert scale (0 = Never; 3 = Always). The questionnaires are scored using spreadsheets provided by the developer. A t-score is computed based on the person's school year. T-scores of 70 and higher are classified as clinically significant. Higher t-scores indicate increased symptoms.

Trial Locations

Locations (3)

King's College London; 🇬🇧 London, United Kingdom

Maudsley Hospital, South London and Maudsley NHS Foundation Trust; 🇬🇧 London, United Kingdom

St Thomas Hospital, Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom