Clinical trial NCT03247075: Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT
Official title: Internet-delivered Cognitive Behavior Therapy Versus Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Social anxiety disorder
Cognitive Behavior Therapy
Internet-delivered treatments
Children and adolescents
Randomized controlled trial
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 103
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Clinician Severity Rating (CSR)
timeFrame: 6 months (14 months including follow-up)
Secondary outcomes:
measure: Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Social anxiety disorder
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Comorbid disorders
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: Measured over the course of 3 months (12 months including follow-up)
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version
timeFrame: 6 months (14 months including follow-up)
measure: Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Revised Children´s Anxiety and Depression Scale - (RCADS) Depression sub scale - Child version
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Anticipatory social behaviors scale (ASBQ)
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Post-event processing questionnaire revised (PEPQ-R)
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Focus of attention questionnaire (FAQ)
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: The Subtle Avoidance Frequency Examination (SAFE)
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: The Child Health Utility 9D (CHU 9D) - Child version
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Client Satisfaction Questionnaire (CSQ-) - Child version
timeFrame: Measured only at post-treatment
measure: Client Satisfaction Questionnaire (CSQ-) - Parent version
timeFrame: Measured only at post-treatment
measure: Treatment credibility and expectancy - Child version
timeFrame: Measured at one time-point, at week three in the allocated intervention.
measure: Treatment credibility and expectancy - Parent version
timeFrame: Measured at one time-point, at week three in the allocated intervention.
measure: Education, Work and Social Adjustment Scale (EWSAS) - Parent version
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Measured only at pre-treatments
measure: Alcohol Disorder Identification Test (AUDIT)
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Family Accommodation Scale-Anxiety (FASA)
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Child version
timeFrame: Measured over the course of 6 months (14 months including follow-up)
measure: The Negative Effects Questionnaire (NEQ)
timeFrame: Measured only at post-treatment
measure: Internet intervention Patient Adherence Scale (iiPAS)
timeFrame: Measured at mid-treatment (week 5) and at post-treatment (week 10)
measure: School absenteeism
timeFrame: Measured over the course of 6 months (14 months including follow-up)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: BUP KFE
state: Stockholms County
Study officials:
affiliation: Karolinska Institutet
name: Eva Serlachius, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nordh M, Wahlund T, Jolstedt M, Sahlin H, Bjureberg J, Ahlen J, Lalouni M, Salomonsson S, Vigerland S, Lavner M, Ost LG, Lenhard F, Hesser H, Mataix-Cols D, Hogstrom J, Serlachius E. Therapist-Guided Internet-Delivered Cognitive Behavioral Therapy vs Internet-Delivered Supportive Therapy for Children and Adolescents With Social Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jul 1;78(7):705-713. doi: 10.1001/jamapsychiatry.2021.0469.