Group Therapy Supported Internet-based CBT for Adolescents With Social Anxiety Disorder - A Feasibility Trial (SoFT)
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Group-therapy + ICBT
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring cognitive behavioral therapy;, guided self-help, adolescent
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)
Sites / Locations
- BUP CPF
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group-therapy + ICBT
Arm Description
This is an open trial with only one study arm
Outcomes
Primary Outcome Measures
Clinical Global Impression - Severity
Change from Baseline of social anxiety disorder severity, after 12 weeks and at 6 months after treatment
Secondary Outcome Measures
Presence of DSM-5 Social Anxiety Disorder
Clinical Global Impression - Improvement
Social Phobia and Anxiety Inventory (SPAI) - Child version
Social Phobia and Anxiety Inventory (SPAI) - Parent version
Revised Children´s Anxiety and Depression Scale (RCADS) - Child version
Revised Children´s Anxiety and Depression Scale (RCADS) - Parent version
Children's Global Assessment Scale (CGAS)
Social Phobia Weekly Summary Scale (SPWSS)
Patient ICBT Adherence Scale (PIAS)
KIDSCREEN-10 - Child version
KIDSCREEN-10 - Parent version
Education, Work and Social Adjustment Scale - child version
Education, Work and Social Adjustment Scale - parent version
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)
Client Satisfaction Scale (CSS)
Measurement of anxiety levels during exposure (app)
Unintended treatment effects
Open ended question where participants report any possible negative consequence of the treatment
Technology acceptance scale (TAS) - child version
Technology acceptance scale (TAS) - parent version
Hospital Anxiety and Depression Scale (HADS)
Social Responsiveness Scale - Parent version
DNA through saliva sampling
Attention bias when presented with social stimuli (eye-tracking)
Qualitative interviews of experience from treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02576171
Brief Title
Group Therapy Supported Internet-based CBT for Adolescents With Social Anxiety Disorder - A Feasibility Trial
Acronym
SoFT
Official Title
Group Therapy Supported Internet-based Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder - A Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 15, 2015 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
cognitive behavioral therapy;, guided self-help, adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group-therapy + ICBT
Arm Type
Experimental
Arm Description
This is an open trial with only one study arm
Intervention Type
Behavioral
Intervention Name(s)
Group-therapy + ICBT
Intervention Description
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 Measure Information:
Title
Clinical Global Impression - Severity
Description
Change from Baseline of social anxiety disorder severity, after 12 weeks and at 6 months after treatment
Time Frame
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Secondary Outcome Measure Information:
Title
Presence of DSM-5 Social Anxiety Disorder
Time Frame
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Title
Clinical Global Impression - Improvement
Time Frame
Assessed 12 weeks after treatment starts and 6 months after treatment has ended
Title
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
Title
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
Title
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
Title
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
Title
Children's Global Assessment Scale (CGAS)
Time Frame
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Title
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
Title
Patient ICBT Adherence Scale (PIAS)
Time Frame
Assessed at Mid-6 weeks and 12 weeks after treatment starts
Title
KIDSCREEN-10 - Child version
Time Frame
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Title
KIDSCREEN-10 - Parent version
Time Frame
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Title
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
Title
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
Title
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
Title
Client Satisfaction Scale (CSS)
Time Frame
Assessed at 12 weeks after treatment starts
Title
Measurement of anxiety levels during exposure (app)
Time Frame
Assessed from Mid-4 week to 12 weeks after treatment starts
Title
Unintended treatment effects
Description
Open ended question where participants report any possible negative consequence of the treatment
Time Frame
Assessed at 12 weeks after treatment starts
Title
Technology acceptance scale (TAS) - child version
Time Frame
Assessed at Mid-3 week and 12 weeks after treatment starts
Title
Technology acceptance scale (TAS) - parent version
Time Frame
Assessed at Mid-3 week and 12 weeks after treatment starts
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Assessed at baseline.
Title
Social Responsiveness Scale - Parent version
Time Frame
Assessed at baseline.
Title
DNA through saliva sampling
Time Frame
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Title
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
Title
Qualitative interviews of experience from treatment
Time Frame
Assessed at 12 weeks after treatment starts
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Serlachius, Ass. Prof.
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
BUP CPF
City
Stockholm
ZIP/Postal Code
11330
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
29247101
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.
Results Reference
derived
Learn more about this trial
Group Therapy Supported Internet-based CBT for Adolescents With Social Anxiety Disorder - A Feasibility Trial
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