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

Karolinska Institute

Status: Completed

Conditions: Social Anxiety Disorder

Treatments: Behavioral: Cognitive Behavior Therapy; Behavioral: Support and Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03247075

DNR 2017/1027-31/2

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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103 participants in 2 patient groups

Internet-delivered Cognitive Behavior Therapy

Experimental group

Description:

10 weeks of guided Internet-delivered Cognitive Behavior Therapy

Treatment:

Behavioral: Cognitive Behavior Therapy

Internet-delivered Support and Counseling

Active Comparator group

Description:

10 weeks of guided Internet-delivered support and counseling

Treatment:

Behavioral: Support and Counseling