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

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Karolinska Institute

Status

Completed

Conditions

Social Anxiety Disorder

Treatments

Behavioral: Group-therapy + ICBT

Study type

Interventional

Funder types

Other

Identifiers

NCT02576171
SoFT Pilot

Details and patient eligibility

About

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.

Full 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

Enrollment

30 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Group-therapy + ICBT
Experimental group
Description:
This is an open trial with only one study arm
Treatment:
Behavioral: Group-therapy + ICBT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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