Autism Spectrum DisorderNCT04301141
Using Virtual Reality to Treat Social Anxiety in Autistic Adolescents
A study testing Virtual Reality Assisted Cognitive Behavioural Therapy in people with Autism Spectrum Disorder and Social Anxiety, run by King's College London at 3 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Social Anxiety
- What is being tested?
- Virtual Reality Assisted Cognitive Behavioural Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jan 2021to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
St Thomas Hospital, Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Lauren Taylor, Dr, 0207 188 7188, lauren.taylor@gstt.nhs.uk
Lucy Adams, MSc, 0207 848 5717, lucy.1.adams@kcl.ac.uk
King's College London
London, SE5 8AF
Lucia Valmaggia, Dr, 02078485003, lucia.valmaggia@kcl.ac.uk
Lucy Adams, MSc, 0207 848 5717, lucy.1.adams@kcl.ac.uk
Maudsley Hospital, South London and Maudsley NHS Foundation Trust
London, SE5 8AZ
Emily Simonoff, Prof., 02078485312, pa-simonoff@kcl.ac.uk
Lucy Adams, MSc, 0207 848 5717, lucy.1.adams@kcl.ac.uk
About this study
Official title: Using Virtual Reality Assisted Therapy for Social Anxiety in Adolescents With Autism Spectrum Disorder: A Case Series
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Social Anxiety
- Being tested
- Virtual Reality Assisted Cognitive Behavioural Therapy
- Keywords
- social phobia, anxiety
- Medical subject headings
- Autism Spectrum Disorder, Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Assisted Cognitive Behavioural TherapyOther
Also called VR-CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Reality Assisted Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, anticipated duration of 9 months.
Secondary outcomes (12)
Rate of participant identification.
Number of patients deemed eligible to partake.
Measured: End of recruitment period, maximum duration 7.5 months from study start date.
Recruitment rate.
Proportion of eligible patients successfully recruited (i.e. the proportion of patients approached for whom consent was provided to participate).
Measured: Through study completion, anticipated duration of 9 months.
Rate of participant retention.
The proportion of participants completing each stage of the study (i.e. baseline assessments/measures, therapy and therapy measures, and post-treatment assessments/measures).
Measured: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
Therapy attendance.
The proportion of sessions recommended by the therapist that the patient attended.
Measured: End of therapy up to 20 weeks.
Frequency and number of sessions.
The number and frequency of VR-CBT sessions deemed suitable for each patient.
Measured: Through study completion, anticipated duration of 9 months.
Adverse effects.
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.
Measured: During and immediately after the intervention.
Experience and opinions on the intervention.
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.
Measured: End of therapy up to 20 weeks.
Data completion rates.
Proportion of questionnaires, assessments and interview appointments completed.
Measured: End of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
Homework compliance.
The proportion of homework assignments completed (as indicated by the therapist).
Measured: End of therapy up to 20 weeks.
Change in progress with attaining therapy goals.
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).
Measured: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
Change in anxiety (including social anxiety) and depression levels.
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.
Measured: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
Change in Global Outcome Ratings of Severity of Illness.
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).
Measured: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study startJan 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, National Institute for Health Research, United Kingdom, Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Lucia Valmaggia, Dr, Principal investigator, South London and Maudsley NHS Foundation Trust; King's College LondonEmily Simonoff, Prof, Principal investigator, King's College London; South London and Maudsley NHS Foundation TrustLauren Taylor, Dr, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301141
- Sponsor's protocol ID
- 0c Valmaggia
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality Assisted Therapy for Social Anxiety in Adolescents With Autism Spectrum Disorder: A Case Series
- ClinicalTrials.gov ID
- NCT04301141
- Acronym / sponsor ID
- 0c Valmaggia
- Conditions
- Autism Spectrum Disorder, Social Anxiety
- Keywords
- social phobia, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, National Institute for Health Research, United Kingdom, Guy's and St Thomas' NHS Foundation Trust
- Study start
- Jan 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Assisted Cognitive Behavioural Therapy | Experimental | Other: Virtual Reality Assisted Cognitive Behavioural TherapyBetween 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Diagnosed with photosensitive epilepsy
- Receiving concurrent psychological therapy
- Immediate plans are in-place to change their psychopharmacological medication regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Assisted Cognitive Behavioural TherapyAlso: VR-CBTThe 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. | Other | Virtual Reality Assisted Cognitive Behavioural Therapy |
Primary outcome
VR session completion rate.
Time frame: 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.
12 secondary outcomes
Rate of participant identification.
Time frame: End of recruitment period, maximum duration 7.5 months from study start date.
Recruitment rate.
Time frame: Through study completion, anticipated duration of 9 months.
Rate of participant retention.
Time frame: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
Therapy attendance.
Time frame: End of therapy up to 20 weeks.
Frequency and number of sessions.
Time frame: Through study completion, anticipated duration of 9 months.
Adverse effects.
Time frame: During and immediately after the intervention.
Experience and opinions on the intervention.
Time frame: End of therapy up to 20 weeks.
Data completion rates.
Time frame: End of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
Homework compliance.
Time frame: End of therapy up to 20 weeks.
Change in progress with attaining therapy goals.
Time frame: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
Change in anxiety (including social anxiety) and depression levels.
Time frame: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
Change in Global Outcome Ratings of Severity of Illness.
Time frame: Baseline; end of therapy up to 20 weeks; follow-up: 6 weeks post-treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Valmaggia, Dr principal investigator
South London and Maudsley NHS Foundation Trust; King's College London
Emily Simonoff, Prof principal investigator
King's College London; South London and Maudsley NHS Foundation Trust
Lauren Taylor, Dr principal investigator
Guy's and St Thomas' NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Assisted Cognitive Behavioural Therapy in people with Autism Spectrum Disorder and Social Anxiety, run by King's College London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucia Valmaggia, Dr (02078485003, lucia.valmaggia@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VR session completion rate. (time frame: Through study completion, anticipated duration of 9 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.