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

NCT ID: NCT03247075

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-19
• Study Completion Date: 2020-10-30

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.

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Internet-delivered Cognitive Behavior Therapy

10 weeks of guided Internet-delivered Cognitive Behavior Therapy

Group Type: EXPERIMENTAL

Cognitive Behavior Therapy

Intervention Type: BEHAVIORAL

Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms

Internet-delivered Support and Counseling

10 weeks of guided Internet-delivered support and counseling

Group Type: ACTIVE_COMPARATOR

Support and Counseling

Intervention Type: BEHAVIORAL

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.

Interventions

Cognitive Behavior Therapy

Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Eva Serlachius

Associate professor, child psychiatrist, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Serlachius, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

BUP KFE

Stockholm, Stockholms County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 33978699 (View on PubMed)

Other Identifiers

DNR 2017/1027-31/2

Identifier Type: -

Identifier Source: org_study_id