Social Anxiety DisorderSOFT RCTNCT03247075
Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT
A study testing Cognitive Behavior Therapy and Support and Counseling in people with Social Anxiety Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Social anxiety disorder among youth is highly prevalent and causes significant impairment in the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective treatment, research suggests that many young people with this disorder do not have access to good-quality CBT. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Cognitive Behavior Therapy and Support and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSweden
- Study dates
- 19 Sep 2017to 30 Oct 2020
- 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 10 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
- Age between 10 and 17 years
- 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 alcohol or substance abuse
- 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: Internet-delivered Cognitive Behavior Therapy Versus Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - A Randomized Controlled Trial
Social anxiety disorder among youth is highly prevalent and causes significant impairment in the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective treatment, research suggests that many young people with this disorder do not have access to good-quality CBT. Internet-delivered CBT could be an effective method to increase availability of evidence-based treatments for youth with social anxiety disorder. The primary objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth (10 - 17 years) with social anxiety disorder. The investigators aim to conduct a randomized controlled trial with N = 101 participants. Participants will be randomized to either the active treatment arm (guided ICBT) or to a control condition (guided internet-delivered support and counseling). Follow-ups will be conducted at 3 and 12 months after post-assessment.
- Conditions
- Social Anxiety Disorder
- Being tested
- Cognitive Behavior Therapy, Support and Counseling
- Keywords
- Social anxiety disorder, Cognitive Behavior Therapy, Internet-delivered treatments, Children and adolescents, Randomized controlled trial
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms
Support and CounselingBehavioural
Guided Internet-delivered support and counseling includes educative material about social anxiety and health related issues such as physical activity, nutritious diet, sleep habits etc.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered Cognitive Behavior Therapy | Experimental | 10 weeks of guided Internet-delivered Cognitive Behavior Therapy Receives: Behavioral: Cognitive Behavior Therapy |
| Internet-delivered Support and Counseling | Active comparator | 10 weeks of guided Internet-delivered support and counseling Receives: Behavioral: Support and Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Severity Rating (CSR)
A 0-8 rating by a professional assessor, specifying the severity of social anxiety
Measured: 6 months (14 months including follow-up)
Secondary outcomes (26)
Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Social anxiety disorder
Diagnostic status: Social anxiety disorder
Measured: Measured over the course of 6 months (14 months including follow-up)
Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Comorbid disorders
Diagnostic status: Comorbid psychiatric disorders
Measured: Measured over the course of 6 months (14 months including follow-up)
Clinical Global Impression - Improvement (CGI-I)
A 1-7 rating by a professional assessor, specifying the degree of improvement from treatment
Measured: Measured over the course of 3 months (12 months including follow-up)
Children's Global Assessment Scale (CGAS)
A 0-100 rating by a professional assessor, specifying global functioning
Measured: Measured over the course of 6 months (14 months including follow-up)
Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version
A self-rated measure of severity of social anxiety
Measured: 6 months (14 months including follow-up)
Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version
A parent-rated measure of severity of social anxiety
Measured: Measured over the course of 6 months (14 months including follow-up)
Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version
A parent-rated measure of severity of anxiety and depression
Measured: Measured over the course of 6 months (14 months including follow-up)
Revised Children´s Anxiety and Depression Scale - (RCADS) Depression sub scale - Child version
A parent-rated measure of severity of anxiety and depression
Measured: Measured over the course of 6 months (14 months including follow-up)
Anticipatory social behaviors scale (ASBQ)
A self-rated measure of anticipatory anxiety before social situations
Measured: Measured over the course of 6 months (14 months including follow-up)
Post-event processing questionnaire revised (PEPQ-R)
A self-rated measure of anxiety and rumination experienced after social situations
Measured: Measured over the course of 6 months (14 months including follow-up)
Focus of attention questionnaire (FAQ)
A self-rated measure of self-focus in social situations
Measured: Measured over the course of 6 months (14 months including follow-up)
The Subtle Avoidance Frequency Examination (SAFE)
A self-rated measure of safety behaviors in social situations
Measured: Measured over the course of 6 months (14 months including follow-up)
The Child Health Utility 9D (CHU 9D) - Child version
A self-rated measure of quality of life
Measured: Measured over the course of 6 months (14 months including follow-up)
Client Satisfaction Questionnaire (CSQ-) - Child version
A self-rated measure of treatment satisfaction
Measured: Measured only at post-treatment
Client Satisfaction Questionnaire (CSQ-) - Parent version
A parent-rated measure of treatment satisfaction
Measured: Measured only at post-treatment
Treatment credibility and expectancy - Child version
A self-rated measure of credibility and expectancy of allocated treatment condition
Measured: Measured at one time-point, at week three in the allocated intervention.
Treatment credibility and expectancy - Parent version
A parent-rated measure of credibility and expectancy of allocated treatment condition
Measured: Measured at one time-point, at week three in the allocated intervention.
Education, Work and Social Adjustment Scale (EWSAS) - Parent version
A parent-rated measure of functioning in everyday life
Measured: Measured over the course of 6 months (14 months including follow-up)
Hospital Anxiety and Depression Scale (HADS)
A self-rated measure of anxiety and depression among parents
Measured: Measured only at pre-treatments
Alcohol Disorder Identification Test (AUDIT)
A self-rated screening measure for hazardous and harmful alcohol consumption
Measured: Measured over the course of 6 months (14 months including follow-up)
Drug Use Disorders Identification Test (DUDIT)
A self-rated screening measure for drug-related problems
Measured: Measured over the course of 6 months (14 months including follow-up)
Family Accommodation Scale-Anxiety (FASA)
A parent-rated measure of parental accommodation to the child's anxiety
Measured: Measured over the course of 6 months (14 months including follow-up)
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Child version
A parent-rated measure of direct and indirect costs related to psychiatric illness in children
Measured: Measured over the course of 6 months (14 months including follow-up)
The Negative Effects Questionnaire (NEQ)
A self-rated measure of treatment related adverse and unwanted events
Measured: Measured only at post-treatment
Internet intervention Patient Adherence Scale (iiPAS)
A clinician-rated measure of adherence to the allocated treatment
Measured: Measured at mid-treatment (week 5) and at post-treatment (week 10)
School absenteeism
A parent-rated measure of the frequency of school absenteeism
Measured: Measured over the course of 6 months (14 months including follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start19 Sep 2017
- Primary completion30 Apr 2019
- Study completion30 Oct 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 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, PhD, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247075
- Sponsor's protocol ID
- DNR 2017/1027-31/2
- Acronym
- SOFT RCT
- Status last verified
- Jan 2021
- First submitted
- 8 Aug 2017
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nordh M, Wahlund T, Jolstedt M, Sahlin H, Bjureberg J, Ahlen J, Lalouni M, Salomonsson S, Vigerland S, Lavner M, Ost LG, Lenhard F, Hesser H, Mataix-Cols D, Hogstrom J, Serlachius E. Therapist-Guided Internet-Delivered Cognitive Behavioral Therapy vs Internet-Delivered Supportive Therapy for Children and Adolescents With Social Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jul 1;78(7):705-713. doi: 10.1001/jamapsychiatry.2021.0469.
PubMed 33978699
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavior Therapy Versus Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03247075
- Acronym / sponsor ID
- SOFT RCT / DNR 2017/1027-31/2
- Conditions
- Social Anxiety Disorder
- Keywords
- Social anxiety disorder, Cognitive Behavior Therapy, Internet-delivered treatments, Children and adolescents, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 11 Aug 2017 (actual)
- 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.
Social anxiety disorder among youth is highly prevalent and causes significant impairment in the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective treatment, research suggests that many young people with this disorder do not have access to good-quality CBT. Internet-delivered CBT could be an effective method to increase availability of evidence-based treatments for youth with social anxiety disorder. The primary objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth (10 - 17 years) with social anxiety disorder. The investigators aim to conduct a randomized controlled trial with N = 101 participants. Participants will be randomized to either the active treatment arm (guided ICBT) or to a control condition (guided internet-delivered support and counseling). Follow-ups will be conducted at 3 and 12 months after post-assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered Cognitive Behavior Therapy | Experimental | Behavioral: Cognitive Behavior Therapy10 weeks of guided Internet-delivered Cognitive Behavior Therapy |
| Internet-delivered Support and Counseling | Active comparator | Behavioral: Support and Counseling10 weeks of guided Internet-delivered support and counseling |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- A principal diagnosis of social anxiety disorder, as defined by DSM-5
- Age between 10 and 17 years
- 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
Key exclusion criteria (5 listed)
- Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder
- Present risk of suicide
- Ongoing alcohol or substance abuse
- 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 |
|---|---|---|
| Cognitive Behavior TherapyGuided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms | Behavioural | Internet-delivered Cognitive Behavior Therapy |
| Support and CounselingGuided Internet-delivered support and counseling includes educative material about social anxiety and health related issues such as physical activity, nutritious diet, sleep habits etc. | Behavioural | Internet-delivered Support and Counseling |
Primary outcome
Clinician Severity Rating (CSR)
Time frame: 6 months (14 months including follow-up)
A 0-8 rating by a professional assessor, specifying the severity of social anxiety
26 secondary outcomes
Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Social anxiety disorder
Time frame: Measured over the course of 6 months (14 months including follow-up)
Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Comorbid disorders
Time frame: Measured over the course of 6 months (14 months including follow-up)
Clinical Global Impression - Improvement (CGI-I)
Time frame: Measured over the course of 3 months (12 months including follow-up)
Children's Global Assessment Scale (CGAS)
Time frame: Measured over the course of 6 months (14 months including follow-up)
Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version
Time frame: 6 months (14 months including follow-up)
Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version
Time frame: Measured over the course of 6 months (14 months including follow-up)
Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version
Time frame: Measured over the course of 6 months (14 months including follow-up)
Revised Children´s Anxiety and Depression Scale - (RCADS) Depression sub scale - Child version
Time frame: Measured over the course of 6 months (14 months including follow-up)
Anticipatory social behaviors scale (ASBQ)
Time frame: Measured over the course of 6 months (14 months including follow-up)
Post-event processing questionnaire revised (PEPQ-R)
Time frame: Measured over the course of 6 months (14 months including follow-up)
Focus of attention questionnaire (FAQ)
Time frame: Measured over the course of 6 months (14 months including follow-up)
The Subtle Avoidance Frequency Examination (SAFE)
Time frame: Measured over the course of 6 months (14 months including follow-up)
The Child Health Utility 9D (CHU 9D) - Child version
Time frame: Measured over the course of 6 months (14 months including follow-up)
Client Satisfaction Questionnaire (CSQ-) - Child version
Time frame: Measured only at post-treatment
Client Satisfaction Questionnaire (CSQ-) - Parent version
Time frame: Measured only at post-treatment
Treatment credibility and expectancy - Child version
Time frame: Measured at one time-point, at week three in the allocated intervention.
Treatment credibility and expectancy - Parent version
Time frame: Measured at one time-point, at week three in the allocated intervention.
Education, Work and Social Adjustment Scale (EWSAS) - Parent version
Time frame: Measured over the course of 6 months (14 months including follow-up)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Measured only at pre-treatments
Alcohol Disorder Identification Test (AUDIT)
Time frame: Measured over the course of 6 months (14 months including follow-up)
Drug Use Disorders Identification Test (DUDIT)
Time frame: Measured over the course of 6 months (14 months including follow-up)
Family Accommodation Scale-Anxiety (FASA)
Time frame: Measured over the course of 6 months (14 months including follow-up)
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Child version
Time frame: Measured over the course of 6 months (14 months including follow-up)
The Negative Effects Questionnaire (NEQ)
Time frame: Measured only at post-treatment
Internet intervention Patient Adherence Scale (iiPAS)
Time frame: Measured at mid-treatment (week 5) and at post-treatment (week 10)
School absenteeism
Time frame: Measured over the course of 6 months (14 months including follow-up)
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 26 Jan 2021.
- Derived from this study: PubMed 33978699Nordh M, Wahlund T, Jolstedt M, Sahlin H, Bjureberg J, Ahlen J, Lalouni M, Salomonsson S, Vigerland S, Lavner M, Ost LG, Lenhard F, Hesser H, Mataix-Cols D, Hogstrom J, Serlachius E. Therapist-Guided Internet-Delivered Cognitive Behavioral Therapy vs Internet-Delivered Supportive Therapy for Children and Adolescents With Social Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jul 1;78(7):705-713. doi: 10.1001/jamapsychiatry.2021.0469.
- Individual participant dataSharing planned: No
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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, PhD, MD 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 Cognitive Behavior Therapy and Support and Counseling 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 6 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 26 Jan 2021. 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?
Clinician Severity Rating (CSR) (time frame: 6 months (14 months including follow-up)). 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 NCT03247075, 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 26 Jan 2021.