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

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ClinicalTrials.gov Identifier: NCT02576171
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Eva Serlachius, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Behavioral: Group-therapy + ICBT Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group Therapy Supported Internet-based Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder - A Feasibility Trial
Actual Study Start Date : October 15, 2015
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Group-therapy + ICBT
This is an open trial with only one study arm
Behavioral: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576171


Locations
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Sweden
BUP CPF
Stockholm, Sweden, 11330
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Eva Serlachius, Ass. Prof. Karolinska Institutet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eva Serlachius, Associate professor, child psychiatrist, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02576171     History of Changes
Other Study ID Numbers: SoFT Pilot
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Keywords provided by Eva Serlachius, Karolinska Institutet:
cognitive behavioral therapy;
guided self-help
adolescent
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders