Is internet cognitive therapy more effective than a waitlist at treating social anxiety disorder in adolescents?
| ISRCTN | ISRCTN15079139 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15079139 |
| Secondary identifying numbers | OSCA Protocol v1. |
- Submission date
- 30/01/2019
- Registration date
- 06/02/2019
- Last edited
- 10/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Adolescent social anxiety disorder (SAD) is common, impairing and persistent. There is a need to intervene early to avert its long-term consequences. Cognitive Therapy for SAD is the leading treatment for adults and shows promise for adolescents. However, given the scale of the problem of adolescent SAD and the limited availability of psychological therapists in child and adolescent mental health services, there is a substantial gap in service provision. Delivering therapy via the Internet may provide part of the solution to this problem. An Internet version of adult Cognitive Therapy for SAD has been developed, with outcomes similar to face-to-face therapy. We have recently adapted this treatment for use with adolescents with SAD. Online social anxiety cognitive therapy for adolescents (OSCA) includes all of the key elements of treatment found in face-to-face therapy. In addition, users can access video demonstrations of key procedures before they try them themselves, they can also practice giving presentations to virtual audiences in preparation for real life situations, and they can receive encouragement from a remote therapist using secure messaging. The main aim of the trial is to compare the effectiveness of OSCA to waitlist. This trial will provide preliminary evidence on whether this intervention, requiring relatively low levels of therapist input, is safe and clinically effective. If this is shown to be the case, OSCA has the potential to provide a service to the large population of adolescents with untreated SAD.
Who can take part?
Adolescents attending partnering comprehensive schools aged 14 to 18 years of age with a diagnosis of social anxiety disorder as their main presenting problem.
What does the study involve?
OSCA will be compared with a wait-list control. Adolescents with social anxiety disorder will be randomly allocated to either a 14-week wait-list, or OSCA (14 weeks with email and phone support from a therapist). The wait-list group is included to determine whether OSCA is superior to no treatment. Patients allocated to the wait-list will receive OSCA at the end of the wait period. Adolescents who are randomly allocated to receive OSCA will be followed up at 3 and 6 months after the end of treatment, to see if the benefits have been maintained. Main assessments will take place at baseline (pre-treatment/wait), mid-treatment/mid-wait (8 weeks), end of treatment/End-wait (15 weeks), 3 month post-treatment follow-up and 6 month post-treatment follow-up.
What are the possible benefits and risks of participating?
All participants will receive treatment for social anxiety disorder from a team that specialises in treatment of the disorder, either immediately or after a 3 month wait. At the end of treatment they will be followed up for a further 6 months to assess the stability of treatment gains. Weekly measures of social anxiety and depressed mood will be taken and so in the unlikely event that symptoms worsen appropriate procedures will be followed to ensure the individual is helped to access services as needed.
Where is the study run from?
Oxford Centre for Anxiety Disorders and Trauma (UK)
When is the study starting and how long is it expected to run for?
March 2019 to May 2021
Who is funding the study?
Wellcome Trust (UK).
Who is the main contact?
Dr. Eleanor Leigh
eleanor.leigh@psy.ox.ac.uk
Contact information
Scientific
OxCADAT, The Old Rectory
Paradise Square
Oxford
OX1 1TW
United Kingdom
 ORCID ID |
0000-0003-2756-3770 |
|---|---|
| Phone | +44 (0)1865618600 |
| eleanor.leigh@psy.ox.ac.uk |
Public
OxCADAT, The Old Rectory
Paradise Square
Oxford
OX1 1TW
United Kingdom
| ORCID ID |
0000-0003-2756-3770 |
|---|---|
| Phone | +44 (0)1865618600 |
| eleanor.leigh@psy.ox.ac.uk |
Study information
| Study design | Two-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Online Social anxiety Cognitive therapy for Adolescents: a randomised controlled trial |
| Study acronym | OSCA |
| Study objectives | 1. Is OSCA an effective therapy for social anxiety disorder in adolescents, compared to waitlist. 2. What is the mechanism by which OSCA achieves its effects? 3. Can we predict which young people are likely to benefit? |
| Ethics approval(s) | Approved 22/11/2018, University of Oxford Medical Sciences Division Ethics Committee (University of Oxford, Wellington Square, Oxford, OX1 2JD; +441865 (6)16577; ethics@medsci.ox.ac.uk), ref: R60464/RE001. |
| Health condition(s) or problem(s) studied | Social anxiety disorder |
| Intervention | Internet-based cognitive therapy for adolescent social anxiety disorder (OSCA) is an adapted version of an adult internet cognitive therapy programme based on the Clark & Wells (1995) model and developed by the Oxford-London Wellcome Anxiety Research Team. The internet cognitive therapy for adult social anxiety has been compared to face-to-face cognitive therapy in a randomised controlled trial (ISRCTN95458747) and found to have similar effects. We undertook a consultation study with adolescents to determine what changes were required to the adult internet treatment to ensure it was acceptable and appropriate for adolescents. The treatment was well-received by the adolescents and only minor changes were suggested. Specifically, it was suggested that the video material, scenarios and clinical vignettes be updated to ensure they are relevant to adolescents (e.g. changing work settings to schools). OSCA covers all the main steps included in adult internet therapy (which includes all the main steps in face-to-face therapy). Adolescents receive Internet treatment for 14 weeks, with the duration of all brief therapist contact recorded. During the 14 weeks, patients will have a 10-15 minute phone conversation with their therapist each week. In addition, they will receive encouragement and support via secure messaging (e-mail) within the internet programme and SMS texts. Following this, they will retain access to the site for 1 year without therapist contact. 14 week wait list control condition, after which patients will receive OSCA. OSCA (intervention arm): The intervention lasts for 14 weeks. Waitlist (control arm): Those randomised to the waitlist condition will being OSCA following a 14-week wait period. The principal assessment points will be at baseline, midtreatment/wait, posttreatment/wait, and three and six month follow-up. Randomisation process: Participants will be randomised in a 1:1 ratio using block randomisation with varying block size. Allocation will be stratified by age and gender. |
| Intervention type | Other |
| Primary outcome measure | 1. Severity of social anxiety will be measured using the self-report version of the Liebowitz Social Anxiety Scale for Children and Adolescents (Masia, Klein, & Liebowitz, 1999). The principal assessment points are baseline, midtreatment/wait, posttreatment/wait, and at 3 and 6 month follow-up. 2. Recovery from social anxiety disorder will be measured using the proportion of adolescents who continue to meet DSM-5 diagnostic criteria for SAD at posttreatment/wait. Diagnosis will be made using The Anxiety Disorders Interview Schedule IV for Children and Parents (Silverman & Albano, 1996). Assessments will be completed face-to-face or over the telephone by trained assessors blind to treatment condition. All participants will be interviewed with the child version and parents will be interviewed where possible. Participants who withdraw from the study will also be invited to complete the assessments.. |
| Secondary outcome measures | 1. Social anxiety will be measured using the Adolescent Social Phobia Weekly Summary Scale (Clark, 2003). The principal assessment points are baseline, midtreatment/wait, posttreatment/wait, and at 3 and 6 month follow-up. 2. General anxiety will be measured using the Revised Child Anxiety & Depression Scale (RCADS, self-report; Chorpita et al. (2000)) at baseline, posttreatment/wait, and at 3 and 6 month follow-up. 3. Depression will be measured using the Short Mood and Feelings Questionnaire (SMFQ; Angold et al. (1995)). The principal assessment points are baseline, midtreatment/wait, posttreatment/wait, and at 3 and 6 month follow-up. 4. Social functioning (including social satisfaction, friendship quality, and peer victimization) will be assessed using self-report questionnaires at baseline, midtreatment/wait, posttreatment/wait, and at 3 and 6 month follow-up. 5. School functioning will be determined using: 5.1. % attendance and grade average (either internal or external examination scores or grade estimate) at baseline, posttreatment/wait and at 6 months follow-up. 5.2. Self-reported ability to concentrate in class (Leigh & Clark, 2016). The principal assessment points are baseline, midtreatment/wait, posttreatment/wait, and at 3 and 6 month follow-up. 6. Thoughts related to social anxiety will be measured using the Adolescent Social Cognitions Questionnaire. The principal assessment points are baseline, midtreatment/wait, posttreatment/wait, and at 3 and 6 month follow-up. 7. Safety behaviours related to social anxiety will be measured using the Adolescent Social Behaviours Questionnaire at baseline, midtreatment/wait, posttreatment/wait, and at 3 and 6 month follow-up. 8. Social attitudes will be measured using the Adolescent Social Attitudes Questionnaire at baseline, midtreatment/wait, posttreatment/wait, and at 3 and 6 month follow-up. 9. How believable, convincing and logical the treatment is will be measured using the treatment credibility scale (Borkovec and Nau, 1972). This will be measured two weeks after the start of treatment. 10. The strength of the therapeutic relationship will be measured using the working alliance inventory (Tracey & Kokotovic, 1989). This will be measured two weeks after the start of treatment. |
| Overall study start date | 01/02/2019 |
| Completion date | 01/05/2021 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 14 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 43 |
| Key inclusion criteria | 1. Adolescents aged between 14-18 years 2. Meet diagnostic criteria for social anxiety disorder (SAD) 3. Able to read and write in English |
| Key exclusion criteria | 1. Currently receiving any other psychological intervention 2. Previously received Cognitive Therapy or CBT for SAD 3. Autism spectrum disorder 4. Learning disability 5. Current alcohol or substance dependence 6. Presence or suspected presence of psychosis 7. Suicidal intent or recurrent self-harming behaviour 8. Identified by social services as currently ‘at risk’ due to child protection concerns. |
| Date of first enrolment | 01/03/2019 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Paradise Square
Oxford
OX1 1TW
United Kingdom
Sponsor information
University/education
OxCADAT
The Old Rectory
Paradise Square
Oxford
OX1 1TW
England
United Kingdom
| Phone | +44 (0)1865618600 |
|---|---|
| oxcadat.enquiries@psy.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Research organisation
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | After the study has finished, the anonymous datasets analysed during the study will be stored at the University of Oxford via the Bodleian ORA-Data archive for 20 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/10/2019 | 10/10/2019 | Yes | No |
| Results article | 09/08/2022 | 10/08/2022 | Yes | No |
Editorial Notes
10/08/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
25/11/2021: The recruitment end date was changed from 30/01/2021 to 31/12/2020.
23/11/2021: The following changes were made to the trial record:
1. The recruitment resumed in September 2020.
2. The recruitment end date was changed from 01/12/2020 to 30/01/2021.
09/07/2020: The trial contact details have been made publicly visible.
15/04/2020: Due to current public health guidance, recruitment for this study has been paused.
10/10/2019: Publication reference added.
31/01/2019: Trial's existence confirmed by Medical Sciences Interdivisional Research Ethics Committee, University of Oxford.
