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

Social Anxiety Disorder Clinical Trial

— SOFT RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247075
• Other study ID #: DNR 2017/1027-31/2
• Status: Completed
• Phase: N/A
• Start date: September 19, 2017
• Est. completion date: October 30, 2020

Study information

• Verified date: January 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 30, 2020
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Cognitive Behavior Therapy
Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms
• Support 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.

Locations

Country	Name	City	State
Sweden	BUP KFE	Stockholm	Stockholms County

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Client Satisfaction Questionnaire (CSQ-) - Child version	A self-rated measure of treatment satisfaction	Measured only at post-treatment
Secondary	Client Satisfaction Questionnaire (CSQ-) - Parent version	A parent-rated measure of treatment satisfaction	Measured only at post-treatment
Secondary	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.
Secondary	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.
Secondary	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)
Secondary	Hospital Anxiety and Depression Scale (HADS)	A self-rated measure of anxiety and depression among parents	Measured only at pre-treatments
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	The Negative Effects Questionnaire (NEQ)	A self-rated measure of treatment related adverse and unwanted events	Measured only at post-treatment
Secondary	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)
Secondary	School absenteeism	A parent-rated measure of the frequency of school absenteeism	Measured over the course of 6 months (14 months including follow-up)