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

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

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavior Therapy; Behavioral: Support and Counseling

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholms County
    • Stockholm, Stockholms County, Sweden, 113 30
      • BUP KFE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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)

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 24, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Cognitive Behavior Therapy; Children and adolescents; Social anxiety disorder; Internet-delivered treatments
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: DNR 2017/1027-31/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No