Group Therapy Supported Internet-based CBT for Adolescents With Social Anxiety Disorder - A Feasibility Trial

NCT ID: NCT02576171

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-15
• Study Completion Date: 2017-01-31

Brief Summary

The primary objectives of this study is to test the feasibility and efficacy of group-therapy supported internet-delivered CBT for adolescents (13 - 17 years) with social anxiety disorder. Investigators will conduct an open trial with N = 30 participants. Participants will be assessed at baseline, immediately after treatment and at a 6-month follow-up.

Detailed Description

Social anxiety disorder (SAD) among youths is highly prevalent and causes significant impairment in the lives of the affected. In spite of CBT being the most effective treatment, evidence suggests that many young people with this disorder do not have access to good-quality CBT. Internet-based CBT is, as numerous prior studies have shown, an effective method to treat psychiatric conditions in adults, but little is known about ICBT for adolescents and there are but a few controlled studies on ICBT for children and adolescents with anxiety disorders. This pilot trial will evaluate the feasibility and efficacy of a blended ICBT-treatment where internet-based and group-based sessions are combined. Furthermore, as ICBT is a novel format in the treatment of psychological problems in young people, it is essential to evaluate the feasibility and acceptability of the technical solutions that carry the active treatment. The study will also include genotyping of participants to further our understanding of etiology of SAD and to explore the relationship between genetic variations and treatment outcome. Additionally, as there is little known about the affect of ASD symptoms on treatment outcome in face-to-face CBT in general, and in ICBT in particular, the association between autistic traits and treatment outcome will be evaluated. Lastly, the role of attentional processes in the maintenance of social anxiety has been scarcely studied and an aim with the current study is to further our understanding of the cognitive factors that underlie SAD

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group-therapy + ICBT

This is an open trial with only one study arm

Group Type: EXPERIMENTAL

Group-therapy + ICBT

Intervention Type: BEHAVIORAL

The group therapy supported ICBT treatment program is a combined web-based and face-to-face intervention that will involve adolescents as well as their parents. The program is founded on and inspired by previously evaluated and evidence-based interventions. Altogether, adolescents go through 12 chapters/sessions, 3 of which are face-to-face group sessions at the research clinic, and 9 of which are web-bases chapters. The program is divided into three different phases, starting with psychoeducation regarding social anxiety and the rationale for a cognitive behavioral intervention. Phase two is the main part of treatment and contains behavioral interventions, mainly exposure and habituation to feared situations and/or stimuli.

Interventions

Group-therapy + ICBT

The group therapy supported ICBT treatment program is a combined web-based and face-to-face intervention that will involve adolescents as well as their parents. The program is founded on and inspired by previously evaluated and evidence-based interventions. Altogether, adolescents go through 12 chapters/sessions, 3 of which are face-to-face group sessions at the research clinic, and 9 of which are web-bases chapters. The program is divided into three different phases, starting with psychoeducation regarding social anxiety and the rationale for a cognitive behavioral intervention. Phase two is the main part of treatment and contains behavioral interventions, mainly exposure and habituation to feared situations and/or stimuli.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• A principal diagnosis of social anxiety disorder, as defined by DSM-5
• 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 substance dependence
• 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: 13 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, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

BUP CPF

Stockholm, , Sweden

Countries

Sweden

References

Nordh M, Vigerland S, Ost LG, Ljotsson B, Mataix-Cols D, Serlachius E, Hogstrom J. Therapist-guided internet-delivered cognitive-behavioural therapy supplemented with group exposure sessions for adolescents with social anxiety disorder: a feasibility trial. BMJ Open. 2017 Dec 14;7(12):e018345. doi: 10.1136/bmjopen-2017-018345.

Reference Type: DERIVED

PMID: 29247101 (View on PubMed)

Other Identifiers

SoFT Pilot

Identifier Type: -

Identifier Source: org_study_id