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

June 21, 2017 updated by: Eva Serlachius, Karolinska Institutet

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11330
        • BUP CPF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group-therapy + ICBT
This is an open trial with only one study arm
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Global Impression - Severity
Time Frame: 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
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Presence of DSM-5 Social Anxiety Disorder
Time Frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Clinical Global Impression - Improvement
Time Frame: Assessed 12 weeks after treatment starts and 6 months after treatment has ended
Assessed 12 weeks after treatment starts and 6 months after treatment has ended
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
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
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
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
Time Frame: Assessed at baseline, Mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Assessed at baseline, Mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
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
Assessed at baseline, mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Children's Global Assessment Scale (CGAS)
Time Frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
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
Assessed at baseline, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Patient ICBT Adherence Scale (PIAS)
Time Frame: Assessed at Mid-6 weeks and 12 weeks after treatment starts
Assessed at Mid-6 weeks and 12 weeks after treatment starts
KIDSCREEN-10 - Child version
Time Frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
KIDSCREEN-10 - Parent version
Time Frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
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
Assessed at baseline, Mid-6 week, 12 weeks after treatment starts and 6 months after treatment has ended
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
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)
Time Frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Client Satisfaction Scale (CSS)
Time Frame: Assessed at 12 weeks after treatment starts
Assessed at 12 weeks after treatment starts
Measurement of anxiety levels during exposure (app)
Time Frame: Assessed from Mid-4 week to 12 weeks after treatment starts
Assessed from Mid-4 week to 12 weeks after treatment starts
Unintended treatment effects
Time Frame: Assessed at 12 weeks after treatment starts
Open ended question where participants report any possible negative consequence of the treatment
Assessed at 12 weeks after treatment starts
Technology acceptance scale (TAS) - child version
Time Frame: Assessed at Mid-3 week and 12 weeks after treatment starts
Assessed at Mid-3 week and 12 weeks after treatment starts
Technology acceptance scale (TAS) - parent version
Time Frame: Assessed at Mid-3 week and 12 weeks after treatment starts
Assessed at Mid-3 week and 12 weeks after treatment starts
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Assessed at baseline.
Assessed at baseline.
Social Responsiveness Scale - Parent version
Time Frame: Assessed at baseline.
Assessed at baseline.
DNA through saliva sampling
Time Frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
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
Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Qualitative interviews of experience from treatment
Time Frame: Assessed at 12 weeks after treatment starts
Assessed at 12 weeks after treatment starts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eva Serlachius, Ass. Prof., Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SoFT Pilot

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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