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

Not Applicable

Completed

• Conditions: Social Anxiety Disorder
• Interventions: Behavioral: Group-therapy + ICBT

• Registration Number: NCT02576171
• Lead Sponsor: 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.

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-14
• Study Start: 2015-10-15
• Study First Posted: 2015-10-15
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group-therapy + ICBT	Group-therapy + ICBT	This is an open trial with only one study arm

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression - Severity	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

Name	Time	Method
Social Responsiveness Scale - Parent version	Assessed at baseline.
DNA through saliva sampling	Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
KIDSCREEN-10 - Parent version	Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Technology acceptance scale (TAS) - parent version	Assessed at Mid-3 week and 12 weeks after treatment starts
Hospital Anxiety and Depression Scale (HADS)	Assessed at baseline.
Client Satisfaction Scale (CSS)	Assessed at 12 weeks after treatment starts
Clinical Global Impression - Improvement	Assessed 12 weeks after treatment starts and 6 months after treatment has ended
Children's Global Assessment Scale (CGAS)	Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
KIDSCREEN-10 - Child version	Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Education, Work and Social Adjustment Scale - child version	Assessed at baseline, Mid-6 week, 12 weeks after treatment starts and 6 months after treatment has ended
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)	Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Measurement of anxiety levels during exposure (app)	Assessed from Mid-4 week to 12 weeks after treatment starts
Revised Children´s Anxiety and Depression Scale (RCADS) - Child version	Assessed at baseline, Mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Presence of DSM-5 Social Anxiety Disorder	Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Social Phobia and Anxiety Inventory (SPAI) - Child version	Assessed at baseline, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Social Phobia and Anxiety Inventory (SPAI) - Parent version	Assessed at baseline, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Social Phobia Weekly Summary Scale (SPWSS)	Assessed at baseline, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Unintended treatment effects	Assessed at 12 weeks after treatment starts	Open ended question where participants report any possible negative consequence of the treatment
Technology acceptance scale (TAS) - child version	Assessed at Mid-3 week and 12 weeks after treatment starts
Revised Children´s Anxiety and Depression Scale (RCADS) - Parent version	Assessed at baseline, mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Patient ICBT Adherence Scale (PIAS)	Assessed at Mid-6 weeks and 12 weeks after treatment starts
Education, Work and Social Adjustment Scale - parent version	Assessed at baseline, Mid-6 week, 12 weeks after treatment starts and 6 months after treatment has ended
Attention bias when presented with social stimuli (eye-tracking)	Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Qualitative interviews of experience from treatment	Assessed at 12 weeks after treatment starts

Trial Locations

Locations (1)

BUP CPF; 🇸🇪 Stockholm, Sweden