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Completed

NCT Number: NCT02576171

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

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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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BUP CPF

Stockholm, 11330, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Group-therapy + ICBT

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.

Primary outcomes

  1. Clinical Global Impression - Severity

    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

Secondary outcomes

  1. Presence of DSM-5 Social Anxiety Disorder

    Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended

  2. Clinical Global Impression - Improvement

    Time frame: Assessed 12 weeks after treatment starts and 6 months after treatment has ended

  3. Social Phobia and Anxiety Inventory (SPAI) - Child version

    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

  4. Social Phobia and Anxiety Inventory (SPAI) - Parent version

    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

  5. Revised Children´s Anxiety and Depression Scale (RCADS) - Child version

    Time frame: Assessed at baseline, Mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended

  6. Revised Children´s Anxiety and Depression Scale (RCADS) - Parent version

    Time frame: Assessed at baseline, mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended

  7. Children's Global Assessment Scale (CGAS)

    Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended

  8. Social Phobia Weekly Summary Scale (SPWSS)

    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

  9. Patient ICBT Adherence Scale (PIAS)

    Time frame: Assessed at Mid-6 weeks and 12 weeks after treatment starts

  10. KIDSCREEN-10 - Child version

    Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended

  11. KIDSCREEN-10 - Parent version

    Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended

  12. Education, Work and Social Adjustment Scale - child version

    Time frame: Assessed at baseline, Mid-6 week, 12 weeks after treatment starts and 6 months after treatment has ended

  13. Education, Work and Social Adjustment Scale - parent version

    Time frame: Assessed at baseline, Mid-6 week, 12 weeks after treatment starts and 6 months after treatment has ended

  14. Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)

    Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended

  15. Client Satisfaction Scale (CSS)

    Time frame: Assessed at 12 weeks after treatment starts

  16. Measurement of anxiety levels during exposure (app)

    Time frame: Assessed from Mid-4 week to 12 weeks after treatment starts

  17. Unintended treatment effects

    Time frame: Assessed at 12 weeks after treatment starts

    Open ended question where participants report any possible negative consequence of the treatment

  18. Technology acceptance scale (TAS) - child version

    Time frame: Assessed at Mid-3 week and 12 weeks after treatment starts

  19. Technology acceptance scale (TAS) - parent version

    Time frame: Assessed at Mid-3 week and 12 weeks after treatment starts

  20. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Assessed at baseline.

  21. Social Responsiveness Scale - Parent version

    Time frame: Assessed at baseline.

  22. DNA through saliva sampling

    Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended

  23. Attention bias when presented with social stimuli (eye-tracking)

    Time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended

  24. Qualitative interviews of experience from treatment

    Time frame: Assessed at 12 weeks after treatment starts

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: SoFT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2015
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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