The effect of Online Social anxiety Cognitive therapy for Adolescents (OSCA) compared to treatment as usual for social anxiety disorder in adolescents
| ISRCTN | ISRCTN21677916 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21677916 |
| IRAS number | 339554 |
| Secondary identifying numbers | CPMS 61644 |
- Submission date
- 06/01/2025
- Registration date
- 08/01/2025
- Last edited
- 24/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study will compare the clinical and cost-effectiveness of internet-delivered therapist-assisted Cognitive Behaviour Therapy (CBT) for adolescent social anxiety, called OSCA (Online Social anxiety Cognitive therapy for Adolescents), to standard treatment. The standard treatment is another form of CBT, called Graded CBT, typically delivered face-to-face.
Who can participate?
Young people aged 11-18 years referred for treatment of social anxiety in an NHS-commissioned service
What does the study involve?
Participants will be randomly allocated to receive one of these treatments. Participants will have 6 study-related assessments: at baseline, 6, 16, 26, and 40 weeks (and 66 weeks if further funding permits) post-randomisation, as well as routine assessments throughout treatment. These will include standard outcome measures used in NHS treatment, and additional assessments of social anxiety symptoms and processes, functioning, and health econometrics. Acceptability of OSCA will be assessed through clinician interviews and clinician and family programme usage data. A subsample of clinicians will be interviewed to understand their experience of delivering OSCA. The study team will examine whether any observed benefits of OSCA are associated with the process measures targeted in the treatment.
What are the possible benefits and risks of participating?
Whichever treatment young people receive as part of their involvement in the study will be an evidence-based therapy. They may enjoy the flexibility of digital therapy if they receive OSCA. Participants may learn about social anxiety through participation in the study. Young people and their families will take part in more thorough assessments throughout which will be used to guide their treatment and they will be invited back for assessments over a longer period after treatment than would be typical as part of routine care, meaning their progress can be checked. Other young people with social anxiety may benefit from your participation, through building knowledge about how to improve treatment.
Participants are not expected to experience any harm as a result of taking part in this study. All researchers involved are experienced and have been approved to work with children and vulnerable adults. Some of the questionnaires may ask things which young people and their families find upsetting. These measures are similar to the ones that are used in usual treatment. Young people and their families can always decide what they would like to discuss in assessment and therapy sessions. Young people and families will be completing more measures than in usual treatment, which they may find frustrating or tiring, but they will be reimbursed for their time.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
January 2024 to December 2027
Who is funding the study?
1. Medical Research Council (MRC) (UK)
2. National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
go.osca@psy.ox.ac.uk
Contact information
Scientific, Principal Investigator
Department of Experimental Psychology
University of Oxford
Oxford
OX2 6GG
United Kingdom
 ORCID ID |
0000-0003-2756-3770 |
|---|---|
| Phone | +44 (0)1865 271444 |
| eleanor.leigh@psy.ox.ac.uk |
Public
Department of Experimental Psychology, University of Oxford
Oxford
OX2 6GG
United Kingdom
| ORCID ID |
0009-0000-2811-3371 |
|---|---|
| Phone | +44 (0)1865 27144 |
| go.osca@psy.ox.ac.uk |
Study information
| Study design | Parallel-assignment randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual, Other therapist office, Telephone, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Go-OSCA trial: examining the efficacy of online social anxiety cognitive therapy for adolescents (OSCA) compared to treatment as usual for social anxiety disorder in adolescents |
| Study acronym | GO-OSCA |
| Study objectives | 1. Is OSCA superior to standard care (Graded CBT) delivered by routinely trained clinicians working in NHS-commissioned services in terms of social anxiety symptoms, as well as broader anxiety and depression symptoms and functioning? 2. Is OSCA cost-efficient compared to standard care (Graded CBT)? 3. Are any observed benefits of OSCA compared to standard care associated with changes in social anxiety process measures targeted in OSCA? 4. We will explore acceptability of OSCA to clinicians. |
| Ethics approval(s) |
Approved 27/09/2024, London - Riverside Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0) 207 104 8150, 207 104 8243; riverside.rec@hra.nhs.uk), ref: 24/LO/0641 |
| Health condition(s) or problem(s) studied | Social anxiety disorder (SAD) in young people aged 11-18 years |
| Intervention | This interventional study is a parallel RCT in adolescents with SAD. Participants will be randomised to receive either OSCA or General CBT, with a randomisation ratio of 1:1 and stratification based on the key baseline feature that is likely to be associated with outcome (i.e., social anxiety symptom severity assessed by the LSAS-CA-SR). OSCA is a therapist-assisted internet-delivered version of Cognitive Therapy for adolescents with SAD, designed with input from young people with lived experience. During the 14 weeks of treatment, young people allocated to OSCA have short weekly phone or video (via MS Teams) calls with their therapist to review progress, assign new modules, deepen learning, and plan behavioural experiments. Most of the calls are around 20 minutes. Messaging within the programme and via SMS provides summaries of calls, encouragement and support. Graded CBT is the therapy given as standard in the NHS to adolescents with SAD and other common anxiety problems. Treatment will follow a standard procedure in the participating services: it will be delivered face-to-face or via video call (MS Teams) and comprise a total of seven sessions (4 weekly, 2 fortnightly, and 1 at a month). As recommended by each participating service, clinicians will use worksheets that are freely available on the Internet or developed by their service to support the treatment. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-reported social anxiety symptoms as measured by the Liebowitz Social Anxiety Scale for children and adolescents (self-report version; LSAS-CA), at baseline, 16-, 26-, and 40-weeks post-randomisation. |
| Secondary outcome measures | The following secondary outcome measures will be assessed at baseline, 16-, 26-, and 40-weeks post-randomisation: 1. Parent and self-reported general anxiety and depression symptoms as measured by the Revised Child Anxiety and Depression Scale (RCADS) 2. Anxiety-related impairment as measured by the Child Anxiety Impact Scale 3. To assess cost-effectiveness, the self-reported CHU-9D, parent-reported EQ-5D-5L, and parent/carer-report Client Service Receipt Inventory (CSRI) will be completed |
| Overall study start date | 01/01/2024 |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 220 |
| Key inclusion criteria | Clinicians: 1. Working within a participating NHS-commissioned service 2. Willing to participate 3. Clinical capacity and managerial approval to participate Young people: 1. Aged 11-18 years at assessment 2. A DSM-5 diagnosis of social anxiety disorder (American Psychiatric Association, 2013) that has been identified as the primary presenting disorder based on clinical assessment. SAD will be deemed primary if participants meet diagnostic criteria for SAD and this is the difficulty that they associate with most impairment (of any comorbid conditions) and for which they are seeking treatment. 3. Agreement not to start medication during the trial. If on a psychotropic medication at eligibility assessment then this has been stable for 8 weeks and there is an agreement to remain on a stable dose throughout the trial. 4. Agreement not to start another psychological therapy during the trial 5. Able to speak, read and write in English to a level that allows them to access treatment content and measures 6. Willingness to be randomised to either treatment 7. Willing to assent/consent to participate Parents/Carers: 1. Over 18 years of age 2. Able and willing to provide written informed consent for their child’s participation in the study. 3. Willing and able to participate. |
| Key exclusion criteria | Current participant exclusion criteria as of 24/06/2025: Clinicians No further exclusion criteria Young people 1. Diagnosed with a learning disability (i.e., IQ<70). Neither treatment has been sufficiently evaluated with this population 2. Autism has been diagnosed or is suspected (which we operationalise based on clinical assessment and in line with standard local procedures) and one or both of the treatments offered in this trial is considered to require adaptation to accommodate the young person’s autistic traits 3. Another condition is primary. Anxiety is a common feature of conditions that neither broad-based CBT or OSCA were designed to treat (e.g., eating disorder, trauma-related disorders, dissociative disorders, psychosis, somatic symptom and related disorders, gender dysphoria, and autism/ADHD where there are significant unmet social/environmental needs). Where these other conditions are primary, they will require priority assessment and treatment and the individual will not be eligible for inclusion in this study. 4. At high risk of significant harm to self, to other, or from others to the point where managing risk needs to be the primary focus of any intervention 5. Currently receiving a psychological intervention or have received previous treatment with cognitive therapy or Graded CBT for social anxiety 6. There are clear environmental risks that need to be urgently addressed and if addressed are likely to relieve symptoms (e.g., severe and ongoing bullying, subject to current abuse or neglect, ongoing trauma) Parents/Carers No further exclusion criteria Previous participant exclusion criteria: Clinicians a. No further exclusion criteria. Young people a. Diagnosed with a learning disability (i.e., IQ<70). Neither treatment has been sufficiently evaluated with this population. b. Autism has been diagnosed or is suspected (the potential participant has been referred for ASD assessment). c. Another condition is primary. Anxiety is a common feature of conditions that neither broad-based CBT or OSCA were designed to treat (e.g., eating disorder, trauma-related disorders, dissociative disorders, psychosis, somatic symptom and related disorders, gender dysphoria, and autism/ADHD where there are significant unmet social/environmental needs). Where these other conditions are primary, they will require priority assessment and treatment and the individual will not be eligible for inclusion in this study. d. At high risk of significant harm to self, to other, or from others to the point where managing risk needs to be the primary focus of any intervention. e. Currently receiving a psychological intervention or have received previous treatment with cognitive therapy or Graded CBT for social anxiety. f. There are clear environmental risks that need to be urgently addressed and if addressed are likely to relieve symptoms (e.g., severe and ongoing bullying, subject to current abuse or neglect, ongoing trauma). Parents/Carers a. No further exclusion criteria. |
| Date of first enrolment | 13/01/2025 |
| Date of final enrolment | 10/01/2027 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Harry Pitt Building
Earley Gate
Reading
RG6 7BE
United Kingdom
23 Between Towns Road
Oxford
OX4 3LX
United Kingdom
Sponsor information
University/education
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865616482 |
|---|---|
| RGEA.Sponsor@admin.ox.ac.uk | |
| Website | https://www.ox.ac.uk |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 31/12/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results of the trial will be published in peer-reviewed international journals within 2 years after the completion of the study. In line with open access policies, the main publications will be made open access. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
24/06/2025: The participant exclusion criteria were amended.
28/04/2025: National Institute for Health and Care Research was added as a funder.
07/01/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
