BUP CPF
Stockholm, 11330, Sweden
NCT Number: NCT02576171
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.
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Notify Me13 year–17 year
All sexes
Interventional
Not applicable
Stockholm, 11330, Sweden
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Change from Baseline of social anxiety disorder severity, after 12 weeks and at 6 months after treatment
Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at baseline, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at baseline, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at baseline, Mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at baseline, mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at baseline, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at Mid-6 weeks and 12 weeks after treatment starts
Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at baseline, Mid-6 week, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at baseline, Mid-6 week, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at 12 weeks after treatment starts
Time frame: Assessed from Mid-4 week to 12 weeks after treatment starts
Time frame: Assessed at 12 weeks after treatment starts
Open ended question where participants report any possible negative consequence of the treatment
Time frame: Assessed at Mid-3 week and 12 weeks after treatment starts
Time frame: Assessed at Mid-3 week and 12 weeks after treatment starts
Time frame: Assessed at baseline.
Time frame: Assessed at baseline.
Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Time frame: Assessed at 12 weeks after treatment starts
Karolinska Institutet
Other
Group Therapy Supported Internet-based Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder - A Feasibility Trial
Acronym: SoFT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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