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

Karolinska Institutet1 site in 1 country103 target enrollmentSeptember 19, 2017

ConditionsSocial Anxiety Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Social Anxiety Disorder
Sponsor: Karolinska Institutet
Enrollment: 103
Locations: 1
Primary Endpoint: Clinician Severity Rating (CSR)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 19, 2017

End Date

October 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Karolinska Institutet

Responsible Party

Principal Investigator

Eva Serlachius

Associate professor, child psychiatrist, MD

Karolinska Institutet

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)

Outcomes

Primary Outcomes

Clinician Severity Rating (CSR)

Time Frame: 6 months (14 months including follow-up)

A 0-8 rating by a professional assessor, specifying the severity of social anxiety

Secondary Outcomes

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))
Children's Global Assessment Scale (CGAS)(Measured over the course of 6 months (14 months including follow-up))
Client Satisfaction Questionnaire (CSQ-) - Child version(Measured only at post-treatment)
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))
Clinical Global Impression - Improvement (CGI-I)(Measured over the course of 3 months (12 months including follow-up))
Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version(6 months (14 months including follow-up))
Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version(Measured over the course of 6 months (14 months including follow-up))
Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version(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(Measured over the course of 6 months (14 months including follow-up))
Anticipatory social behaviors scale (ASBQ)(Measured over the course of 6 months (14 months including follow-up))
Treatment credibility and expectancy - Parent version(Measured at one time-point, at week three in the allocated intervention.)
Education, Work and Social Adjustment Scale (EWSAS) - Parent version(Measured over the course of 6 months (14 months including follow-up))
Client Satisfaction Questionnaire (CSQ-) - Parent version(Measured only at post-treatment)
Focus of attention questionnaire (FAQ)(Measured over the course of 6 months (14 months including follow-up))
The Subtle Avoidance Frequency Examination (SAFE)(Measured over the course of 6 months (14 months including follow-up))
Alcohol Disorder Identification Test (AUDIT)(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(Measured over the course of 6 months (14 months including follow-up))
The Negative Effects Questionnaire (NEQ)(Measured only at post-treatment)
Post-event processing questionnaire revised (PEPQ-R)(Measured over the course of 6 months (14 months including follow-up))
The Child Health Utility 9D (CHU 9D) - Child version(Measured over the course of 6 months (14 months including follow-up))
Internet intervention Patient Adherence Scale (iiPAS)(Measured at mid-treatment (week 5) and at post-treatment (week 10))
Treatment credibility and expectancy - Child version(Measured at one time-point, at week three in the allocated intervention.)
Hospital Anxiety and Depression Scale (HADS)(Measured only at pre-treatments)
Drug Use Disorders Identification Test (DUDIT)(Measured over the course of 6 months (14 months including follow-up))
Family Accommodation Scale-Anxiety (FASA)(Measured over the course of 6 months (14 months including follow-up))
School absenteeism(Measured over the course of 6 months (14 months including follow-up))