Social Anxiety DisorderSoFTNCT02576171
Group Therapy Supported Internet-based CBT for Adolescents With Social Anxiety Disorder - A Feasibility Trial
A study testing Group-therapy + ICBT in people with Social Anxiety Disorder, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Group-therapy + ICBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 15 Oct 2015to 31 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Social Anxiety Disorder
- Being tested
- Group-therapy + ICBT
- Keywords
- cognitive behavioral therapy;, guided self-help, adolescent
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-therapy + ICBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group-therapy + ICBT | Experimental | This is an open trial with only one study arm Receives: Behavioral: Group-therapy + ICBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression - Severity
Change from Baseline of social anxiety disorder severity, after 12 weeks and at 6 months after treatment
Measured: 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
Measured: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Clinical Global Impression - Improvement
Measured: Assessed 12 weeks after treatment starts and 6 months after treatment has ended
Social Phobia and Anxiety Inventory (SPAI) - Child version
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed at baseline, mid-6 weeks, 12 weeks after treatment starts and 6 months after treatment has ended
Children's Global Assessment Scale (CGAS)
Measured: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Social Phobia Weekly Summary Scale (SPWSS)
Measured: 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)
Measured: Assessed at Mid-6 weeks and 12 weeks after treatment starts
KIDSCREEN-10 - Child version
Measured: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
KIDSCREEN-10 - Parent version
Measured: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Education, Work and Social Adjustment Scale - child version
Measured: 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
Measured: 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)
Measured: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Client Satisfaction Scale (CSS)
Measured: Assessed at 12 weeks after treatment starts
Measurement of anxiety levels during exposure (app)
Measured: Assessed from Mid-4 week to 12 weeks after treatment starts
Unintended treatment effects
Open ended question where participants report any possible negative consequence of the treatment
Measured: Assessed at 12 weeks after treatment starts
Technology acceptance scale (TAS) - child version
Measured: Assessed at Mid-3 week and 12 weeks after treatment starts
Technology acceptance scale (TAS) - parent version
Measured: Assessed at Mid-3 week and 12 weeks after treatment starts
Hospital Anxiety and Depression Scale (HADS)
Measured: Assessed at baseline.
Social Responsiveness Scale - Parent version
Measured: Assessed at baseline.
DNA through saliva sampling
Measured: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Attention bias when presented with social stimuli (eye-tracking)
Measured: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended
Qualitative interviews of experience from treatment
Measured: Assessed at 12 weeks after treatment starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study start15 Oct 2015
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Serlachius, Karolinska Institutet
- Investigators
- Eva Serlachius, Ass. Prof., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576171
- Sponsor's protocol ID
- SoFT Pilot
- Acronym
- SoFT
- Status last verified
- Jun 2017
- First submitted
- 12 Oct 2015
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29247101
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Therapy Supported Internet-based Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder - A Feasibility Trial
- ClinicalTrials.gov ID
- NCT02576171
- Acronym / sponsor ID
- SoFT / SoFT Pilot
- Conditions
- Social Anxiety Disorder
- Keywords
- cognitive behavioral therapy;, guided self-help, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group-therapy + ICBT | Experimental | Behavioral: Group-therapy + ICBTThis is an open trial with only one study arm |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-therapy + ICBTThe 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. | Behavioural | Group-therapy + ICBT |
Primary outcome
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
24 secondary outcomes
Presence of DSM-5 Social Anxiety Disorder
Time frame: 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
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
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
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
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
Children's Global Assessment Scale (CGAS)
Time frame: 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
Patient ICBT Adherence Scale (PIAS)
Time frame: 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
KIDSCREEN-10 - Parent version
Time frame: 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
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
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
Client Satisfaction Scale (CSS)
Time frame: 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
Unintended treatment effects
Time frame: 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
Technology acceptance scale (TAS) - parent version
Time frame: Assessed at Mid-3 week and 12 weeks after treatment starts
Hospital Anxiety and Depression Scale (HADS)
Time frame: Assessed at baseline.
Social Responsiveness Scale - Parent version
Time frame: Assessed at baseline.
DNA through saliva sampling
Time frame: 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
Qualitative interviews of experience from treatment
Time frame: Assessed at 12 weeks after treatment starts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Derived from this study: PubMed 29247101Nordh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Serlachius, Ass. Prof. principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-therapy + ICBT in people with Social Anxiety Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression - Severity (time frame: Assessed at baseline, 12 weeks after treatment starts and 6 months after treatment has ended). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02576171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.