Social Anxiety Disorder
Conditions
Keywords
Social anxiety disorder, Cognitive Behavior Therapy, Internet-delivered treatments, Children and adolescents, Randomized controlled trial
Brief summary
Social anxiety disorder among youth is highly prevalent and causes significant impairment in the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective treatment, research suggests that many young people with this disorder do not have access to good-quality CBT. Internet-delivered CBT could be an effective method to increase availability of evidence-based treatments for youth with social anxiety disorder. The primary objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth (10 - 17 years) with social anxiety disorder. The investigators aim to conduct a randomized controlled trial with N = 101 participants. Participants will be randomized to either the active treatment arm (guided ICBT) or to a control condition (guided internet-delivered support and counseling). Follow-ups will be conducted at 3 and 12 months after post-assessment.
Interventions
BEHAVIORALCognitive Behavior Therapy
Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms
BEHAVIORALSupport and Counseling
Guided Internet-delivered support and counseling includes educative material about social anxiety and health related issues such as physical activity, nutritious diet, sleep habits etc.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* A principal diagnosis of social anxiety disorder, as defined by DSM-5 * Age between 10 and 17 years * Ability to read and write Swedish * Daily access to the internet through a computer or similar device * A parent or caregiver that is able to co-participate in the treatment * Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
Exclusion criteria
* Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder * Present risk of suicide * Ongoing alcohol or substance abuse * Occurrence of domestic violence * Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Severity Rating (CSR) | 6 months (14 months including follow-up) | A 0-8 rating by a professional assessor, specifying the severity of social anxiety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Comorbid disorders | Measured over the course of 6 months (14 months including follow-up) | Diagnostic status: Comorbid psychiatric disorders |
| Clinical Global Impression - Improvement (CGI-I) | Measured over the course of 3 months (12 months including follow-up) | A 1-7 rating by a professional assessor, specifying the degree of improvement from treatment |
| Children's Global Assessment Scale (CGAS) | Measured over the course of 6 months (14 months including follow-up) | A 0-100 rating by a professional assessor, specifying global functioning |
| Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version | 6 months (14 months including follow-up) | A self-rated measure of severity of social anxiety |
| Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version | Measured over the course of 6 months (14 months including follow-up) | A parent-rated measure of severity of social anxiety |
| Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version | Measured over the course of 6 months (14 months including follow-up) | A parent-rated measure of severity of anxiety and depression |
| Revised Children´s Anxiety and Depression Scale - (RCADS) Depression sub scale - Child version | Measured over the course of 6 months (14 months including follow-up) | A parent-rated measure of severity of anxiety and depression |
| Anticipatory social behaviors scale (ASBQ) | Measured over the course of 6 months (14 months including follow-up) | A self-rated measure of anticipatory anxiety before social situations |
| Post-event processing questionnaire revised (PEPQ-R) | Measured over the course of 6 months (14 months including follow-up) | A self-rated measure of anxiety and rumination experienced after social situations |
| Focus of attention questionnaire (FAQ) | Measured over the course of 6 months (14 months including follow-up) | A self-rated measure of self-focus in social situations |
| The Subtle Avoidance Frequency Examination (SAFE) | Measured over the course of 6 months (14 months including follow-up) | A self-rated measure of safety behaviors in social situations |
| The Child Health Utility 9D (CHU 9D) - Child version | Measured over the course of 6 months (14 months including follow-up) | A self-rated measure of quality of life |
| Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Social anxiety disorder | Measured over the course of 6 months (14 months including follow-up) | Diagnostic status: Social anxiety disorder |
| Client Satisfaction Questionnaire (CSQ-) - Parent version | Measured only at post-treatment | A parent-rated measure of treatment satisfaction |
| Treatment credibility and expectancy - Child version | Measured at one time-point, at week three in the allocated intervention. | A self-rated measure of credibility and expectancy of allocated treatment condition |
| Treatment credibility and expectancy - Parent version | Measured at one time-point, at week three in the allocated intervention. | A parent-rated measure of credibility and expectancy of allocated treatment condition |
| Education, Work and Social Adjustment Scale (EWSAS) - Parent version | Measured over the course of 6 months (14 months including follow-up) | A parent-rated measure of functioning in everyday life |
| Hospital Anxiety and Depression Scale (HADS) | Measured only at pre-treatments | A self-rated measure of anxiety and depression among parents |
| Alcohol Disorder Identification Test (AUDIT) | Measured over the course of 6 months (14 months including follow-up) | A self-rated screening measure for hazardous and harmful alcohol consumption |
| Drug Use Disorders Identification Test (DUDIT) | Measured over the course of 6 months (14 months including follow-up) | A self-rated screening measure for drug-related problems |
| Family Accommodation Scale-Anxiety (FASA) | Measured over the course of 6 months (14 months including follow-up) | A parent-rated measure of parental accommodation to the child's anxiety |
| Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Child version | Measured over the course of 6 months (14 months including follow-up) | A parent-rated measure of direct and indirect costs related to psychiatric illness in children |
| The Negative Effects Questionnaire (NEQ) | Measured only at post-treatment | A self-rated measure of treatment related adverse and unwanted events |
| Internet intervention Patient Adherence Scale (iiPAS) | Measured at mid-treatment (week 5) and at post-treatment (week 10) | A clinician-rated measure of adherence to the allocated treatment |
| School absenteeism | Measured over the course of 6 months (14 months including follow-up) | A parent-rated measure of the frequency of school absenteeism |
| Client Satisfaction Questionnaire (CSQ-) - Child version | Measured only at post-treatment | A self-rated measure of treatment satisfaction |
Countries
Sweden
Outcome results
None listed