Clinical trial NCT02576171: Group Therapy Supported Internet-based CBT for Adolescents With Social Anxiety Disorder - A Feasibility Trial
Official title: Group Therapy Supported Internet-based Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder - A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: cognitive behavioral therapy;
guided self-help
adolescent
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Clinical Global Impression - Severity
timeFrame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Secondary outcomes:
measure: Presence of DSM-5 Social Anxiety Disorder
timeFrame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Clinical Global Impression - Improvement
timeFrame: Assessed 12 weeks after treatment starts and 6 months after treatment has ended
measure: Social Phobia and Anxiety Inventory (SPAI) - Child version
timeFrame: Assessed at baseline, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Social Phobia and Anxiety Inventory (SPAI) - Parent version
timeFrame: Assessed at baseline, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Revised Children´s Anxiety and Depression Scale (RCADS) - Child version
timeFrame: Assessed at baseline, Mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Revised Children´s Anxiety and Depression Scale (RCADS) - Parent version
timeFrame: Assessed at baseline, mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Social Phobia Weekly Summary Scale (SPWSS)
timeFrame: Assessed at baseline, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Patient ICBT Adherence Scale (PIAS)
timeFrame: Assessed at Mid-6 weeks and 12 weeks after treatment starts
measure: KIDSCREEN-10 - Child version
timeFrame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
measure: KIDSCREEN-10 - Parent version
timeFrame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Education, Work and Social Adjustment Scale - child version
timeFrame: Assessed at baseline, Mid-6 week, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Education, Work and Social Adjustment Scale - parent version
timeFrame: Assessed at baseline, Mid-6 week, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)
timeFrame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Client Satisfaction Scale (CSS)
timeFrame: Assessed at 12 weeks after treatment starts
measure: Measurement of anxiety levels during exposure (app)
timeFrame: Assessed from Mid-4 week to 12 weeks after treatment starts
measure: Unintended treatment effects
timeFrame: Assessed at 12 weeks after treatment starts
measure: Technology acceptance scale (TAS) - child version
timeFrame: Assessed at Mid-3 week and 12 weeks after treatment starts
measure: Technology acceptance scale (TAS) - parent version
timeFrame: Assessed at Mid-3 week and 12 weeks after treatment starts
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Assessed at baseline.
measure: Social Responsiveness Scale - Parent version
timeFrame: Assessed at baseline.
measure: DNA through saliva sampling
timeFrame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Attention bias when presented with social stimuli (eye-tracking)
timeFrame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
measure: Qualitative interviews of experience from treatment
timeFrame: Assessed at 12 weeks after treatment starts
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: BUP CPF
Study officials:
affiliation: Karolinska Institutet
name: Eva Serlachius, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.