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

NCT02576171 | Completed

• 1 other identifier: SoFT Pilot
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Keywords

cognitive behavioral therapy;; guided self-help; adolescent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Presence of DSM-5 Social Anxiety Disorder

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

• Clinical Global Impression - Improvement

  Assessed 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

• 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

Study Arms (1)

Group-therapy + ICBT

EXPERIMENTAL

This is an open trial with only one study arm

Behavioral: Group-therapy + ICBT

Interventions

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.

Group-therapy + ICBT

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

BUP CPF

Stockholm, 11330, Sweden

Location

Related Publications (1)

• 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.

  PMID: 29247101 DERIVED

MeSH Terms

Conditions

Phobia, Social

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eva Serlachius, Ass. Prof.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, child psychiatrist, MD

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 15, 2015
• Study Start: October 15, 2015
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

SE (1)