Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT

Study Overview
=================
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.

Official Title
-----------------
Internet-delivered Cognitive Behavior Therapy Versus Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - A Randomized Controlled Trial

Conditions
-----------------
Social Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavior Therapy
* Behavioral: Support and Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered Cognitive Behavior Therapy<br>10 weeks of guided Internet-delivered Cognitive Behavior Therapy | Behavioral: Cognitive Behavior Therapy<br>* Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms<br>|
| Active Comparator: Internet-delivered Support and Counseling<br>10 weeks of guided Internet-delivered support and counseling | Behavioral: Support and Counseling<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Severity Rating (CSR) | A 0-8 rating by a professional assessor, specifying the severity of social anxiety | 6 months (14 months including follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Social anxiety disorder | Diagnostic status: Social anxiety disorder | Measured over the course of 6 months (14 months including follow-up) | 
| Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Comorbid disorders | Diagnostic status: Comorbid psychiatric disorders | Measured over the course of 6 months (14 months including follow-up) | 
| Clinical Global Impression - Improvement (CGI-I) | A 1-7 rating by a professional assessor, specifying the degree of improvement from treatment | Measured over the course of 3 months (12 months including follow-up) | 
| Children's Global Assessment Scale (CGAS) | A 0-100 rating by a professional assessor, specifying global functioning | Measured over the course of 6 months (14 months including follow-up) | 
| Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version | A self-rated measure of severity of social anxiety | 6 months (14 months including follow-up) | 
| Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version | A parent-rated measure of severity of social anxiety | Measured over the course of 6 months (14 months including follow-up) | 
| Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version | A parent-rated measure of severity of anxiety and depression | Measured over the course of 6 months (14 months including follow-up) | 
| Revised Children´s Anxiety and Depression Scale - (RCADS) Depression sub scale - Child version | A parent-rated measure of severity of anxiety and depression | Measured over the course of 6 months (14 months including follow-up) | 
| Anticipatory social behaviors scale (ASBQ) | A self-rated measure of anticipatory anxiety before social situations | Measured over the course of 6 months (14 months including follow-up) | 
| Post-event processing questionnaire revised (PEPQ-R) | A self-rated measure of anxiety and rumination experienced after social situations | Measured over the course of 6 months (14 months including follow-up) | 
| Focus of attention questionnaire (FAQ) | A self-rated measure of self-focus in social situations | Measured over the course of 6 months (14 months including follow-up) | 
| The Subtle Avoidance Frequency Examination (SAFE) | A self-rated measure of safety behaviors in social situations | Measured over the course of 6 months (14 months including follow-up) | 
| The Child Health Utility 9D (CHU 9D) - Child version | A self-rated measure of quality of life | Measured over the course of 6 months (14 months including follow-up) | 
| Client Satisfaction Questionnaire (CSQ-) - Child version | A self-rated measure of treatment satisfaction | Measured only at post-treatment | 
| Client Satisfaction Questionnaire (CSQ-) - Parent version | A parent-rated measure of treatment satisfaction | Measured only at post-treatment | 
| Treatment credibility and expectancy - Child version | A self-rated measure of credibility and expectancy of allocated treatment condition | Measured at one time-point, at week three in the allocated intervention. | 
| Treatment credibility and expectancy - Parent version | A parent-rated measure of credibility and expectancy of allocated treatment condition | Measured at one time-point, at week three in the allocated intervention. | 
| Education, Work and Social Adjustment Scale (EWSAS) - Parent version | A parent-rated measure of functioning in everyday life | Measured over the course of 6 months (14 months including follow-up) | 
| Hospital Anxiety and Depression Scale (HADS) | A self-rated measure of anxiety and depression among parents | Measured only at pre-treatments | 
| Alcohol Disorder Identification Test (AUDIT) | A self-rated screening measure for hazardous and harmful alcohol consumption | Measured over the course of 6 months (14 months including follow-up) | 
| Drug Use Disorders Identification Test (DUDIT) | A self-rated screening measure for drug-related problems | Measured over the course of 6 months (14 months including follow-up) | 
| Family Accommodation Scale-Anxiety (FASA) | A parent-rated measure of parental accommodation to the child's anxiety | Measured over the course of 6 months (14 months including follow-up) | 
| Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Child version | A parent-rated measure of direct and indirect costs related to psychiatric illness in children | Measured over the course of 6 months (14 months including follow-up) | 
| The Negative Effects Questionnaire (NEQ) | A self-rated measure of treatment related adverse and unwanted events | Measured only at post-treatment | 
| Internet intervention Patient Adherence Scale (iiPAS) | A clinician-rated measure of adherence to the allocated treatment | Measured at mid-treatment (week 5) and at post-treatment (week 10) | 
| School absenteeism | A parent-rated measure of the frequency of school absenteeism | Measured over the course of 6 months (14 months including follow-up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social anxiety disorder, Cognitive Behavior Therapy, Internet-delivered treatments, Children and adolescents, Randomized controlled trial