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

Social Anxiety Disorder Clinical Trial

— SoFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576171
• Other study ID #: SoFT Pilot
• Status: Completed
• Phase: N/A
• First received: October 12, 2015
• Last updated: June 21, 2017
• Start date: October 15, 2015
• Est. completion date: January 31, 2017

Study information

• Verified date: June 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobic Disorders
• Social Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
Sweden	BUP CPF	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression - Severity	Change from Baseline of social anxiety disorder severity, after 12 weeks and at 6 months after treatment	Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Secondary	Presence of DSM-5 Social Anxiety Disorder		Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Secondary	Clinical Global Impression - Improvement		Assessed 12 weeks after treatment starts and 6 months after treatment has ended
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Children's Global Assessment Scale (CGAS)		Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Secondary	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
Secondary	Patient ICBT Adherence Scale (PIAS)		Assessed at Mid-6 weeks and 12 weeks after treatment starts
Secondary	KIDSCREEN-10 - Child version		Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Secondary	KIDSCREEN-10 - Parent version		Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Secondary	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
Secondary	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
Secondary	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
Secondary	Client Satisfaction Scale (CSS)		Assessed at 12 weeks after treatment starts
Secondary	Measurement of anxiety levels during exposure (app)		Assessed from Mid-4 week to 12 weeks after treatment starts
Secondary	Unintended treatment effects	Open ended question where participants report any possible negative consequence of the treatment	Assessed at 12 weeks after treatment starts
Secondary	Technology acceptance scale (TAS) - child version		Assessed at Mid-3 week and 12 weeks after treatment starts
Secondary	Technology acceptance scale (TAS) - parent version		Assessed at Mid-3 week and 12 weeks after treatment starts
Secondary	Hospital Anxiety and Depression Scale (HADS)		Assessed at baseline.
Secondary	Social Responsiveness Scale - Parent version		Assessed at baseline.
Secondary	DNA through saliva sampling		Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Secondary	Attention bias when presented with social stimuli (eye-tracking)		Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Secondary	Qualitative interviews of experience from treatment		Assessed at 12 weeks after treatment starts