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
1 other identifier
interventional
103
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2017
CompletedFirst Posted
Study publicly available on registry
August 11, 2017
CompletedStudy Start
First participant enrolled
September 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedJanuary 26, 2021
January 1, 2021
1.6 years
August 8, 2017
January 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (26)
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)
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)
Clinical Global Impression - Improvement (CGI-I)
Measured over the course of 3 months (12 months including follow-up)
Children's Global Assessment Scale (CGAS)
Measured over the course of 6 months (14 months including follow-up)
Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version
6 months (14 months including follow-up)
- +21 more secondary outcomes
Study Arms (2)
Internet-delivered Cognitive Behavior Therapy
EXPERIMENTAL10 weeks of guided Internet-delivered Cognitive Behavior Therapy
Internet-delivered Support and Counseling
ACTIVE COMPARATOR10 weeks of guided Internet-delivered support and counseling
Interventions
Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BUP KFE
Stockholm, Stockholms County, 113 30, Sweden
Related Publications (1)
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.
PMID: 33978699DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Serlachius, PhD, MD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor, child psychiatrist, MD
Study Record Dates
First Submitted
August 8, 2017
First Posted
August 11, 2017
Study Start
September 19, 2017
Primary Completion
April 30, 2019
Study Completion
October 30, 2020
Last Updated
January 26, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share