Social AnxietySOPHIENCT04782102

SOPHIE: Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents

A study testing SOPHIE Intervention in people with Social Anxiety and Social Anxiety Disorder, run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 11 to 17 years
Conditions the study is for: Social Anxiety, Social Anxiety Disorder
What is being tested?: SOPHIE Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 1 siteSwitzerland
Study dates: 7 Jun 2021to 31 Mar 2024
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 11 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age between 11;00 (11 years and 0 months) and 17;11 (17 years and 11 months)
Good written and spoken German language skills
Access to an Internet connection and a device to use the intervention (tablet, smartphone, PC) and to collect the EMA data (smartphone)
Subclinical values on the SPIN (value: 16-23; Loscalzo et al., 2018) or criteria for social anxiety disorder according to Kinder-DIPS (Schneider et al., 2017)
Written consent of the adolescent (if at least 14 years old) or the parents or guardian (if adolescent under 14 years old) and assent of adolescent under 14 years old

Who cannot join

Known diagnosis of autism spectrum disorder
Current suicidal ideation (collected via PHQ-A Item 9)
Lack of knowledge of the German language in spoken and written form
Past diagnosis of social anxiety according to the DSM-5 criteria assessed by the Kinder-DIPS (Schneider et al., 2017) in participants with current subclinical anxiety

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

University of Bern
Bern, 3012

Other trials in Switzerland

About this study

Official title: SOPHIE: a Randomised Controlled Trial to Investigate the Efficacy of Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents

This study's aim is to investigate the efficacy of the online-intervention SOPHIE. SOPHIE is an online-intervention for adolescents with social anxiety. In Switzerland, Germany, Austria and Liechtenstein, about one in 15 adolescents suffers from social anxiety. The SOPHIE intervention aims to help these adolescents to better understand and cope with their social anxiety symptoms and to feel more comfortable in social situations. The investigators intend to include 248 adolescents in the study. Stratified by subclinical and clinical level of social anxiety, participants will be randomly assigned to the SOPHIE group or the control group receiving care-as-usual. Both groups will complete online questionnaires and will be interviewed via telephone several times during the study. This allows to compare the two groups regarding their efficacy of the SOPHIE programme in terms of changes in social anxiety over time.

Conditions: Social Anxiety, Social Anxiety Disorder
Being tested: SOPHIE Intervention
Keywords: Prevention, Intervention, Adolescents, Youths, Online-Intervention, Internet-Intervention
Medical subject headings: Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SOPHIE InterventionBehavioural
SOPHIE is an online-intervention aiming to reduce social anxiety in adolescents. SOPHIE has 8 modules, one module per week, which lasts about 60 minutes. SOPHIE includes elements of evidence-based psychotherapeutic interventions to reduce social anxiety and of an existing online-intervention for adults with social anxiety adopted to the needs of adolescents. The intervention consists of psychoeducation (how social anxieties arise), application examples (e.g. setting up a personal anxiety cycle or anxiety pyramid, imagination exercise: journey to a safe place), and contains weekly tasks for which regular repetition in everyday life is important (e.g. progressive muscle relaxation, observing anxiety in everyday life, exposures in various situations). At the end of each module, a short quiz allows participants to recall and consolidate what they have learned. The content is presented in video inputs, short explanatory texts, application tasks and quizzes.

Study groups in NCT04782102
Study group	Role	What they receive
SOPHIE Intervention	Experimental	SOPHIE is an online-intervention aiming to reduce social anxiety in adolescents. SOPHIE has 8 modules, one module per week, which lasts about 60 minutes. SOPHIE includes elements of evidence-based psychotherapeutic interventions to reduce social anxiety and of an existing online-intervention for adults with social anxiety adopted to the needs of adolescents. The intervention consists of psychoeducation (how social anxieties arise), application examples (e.g. setting up a personal anxiety cycle or anxiety pyramid, imagination exercise: journey to a safe place), and contains weekly tasks for which regular repetition in everyday life is important (e.g. progressive muscle relaxation, observing anxiety in everyday life, exposures in various situations). At the end of each module, a short quiz allows participants to recall and consolidate what they have learned. The content is presented in video inputs, short explanatory texts, application tasks and quizzes. Receives: Behavioral: SOPHIE Intervention
Care-as-usual	No intervention	Care-As-Usual: all other kinds of interventions are allowed and will be recorded using the Client Sociodemographic and Service Receipt Inventory (Chisholm et al., 2000; Roick et al., 2001)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in social anxiety assessed by the Social Phobia Inventory (SPIN; Connor et al., German Version: Sosic et al., 2008)
Measure of social anxiety, total score ranging from 0 - 68 (representing the sum of each of the 17 individual items). Lower scores represent less social anxiety and a more favourable outcome.
Measured: Baseline assessment compared to assessment at post-intervention (2 months after baseline)

Secondary outcomes (10)

Current and past mental disorder assessed by the structured diagnostic interview for mental disorders of childhood and adolescence (Kinder-DIPS; Schneider et al., 2017)
At Baseline, the entire Kinder-DIPS will be assessed. At post and follow-up, only the sections for social anxiety and comorbid diagnoses met at baseline are assessed.
Measured: Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention);
Change in global functioning assessed by the GF Social (Cornblatt et al., 2007)
Structured interview assessing the level of functioning in social areas of life (friends \& family) ranging from 1 to 10, higher scores indicate a better level of functioning
Measured: Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention)
Change in global functioning assessed by the GF Role Scale (Cornblatt et al., 2007)
Structured interview assessing the level of functioning in school / work ranging from 1 to 10, higher scores indicate a better level of functioning
Measured: Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention)
Utilisation of help assessed by the Client Sociodemographic and Service Receipt Inventory (CSSRI-EU; Chisholm et al., 2000; Roick et al., 2001)
Structured interview assessing the additional use of psychological, medical and other formal and informal services and sources of help (e.g. at school, friends)
Measured: Assessed at post-intervention (2 months after baseline) and follow-up (5 months after baseline)
Change of fear of negative evaluation and avoidance assessed by the Social Anxiety Scale for Adolescents (SAS-A; La Greca & Lopez,1998)
Total score ranging from 18 - 90 (representing the sum of each of the 18 individual items). Lower scores represent less fear of negative evaluation and avoidance and a more favourable outcome.
Measured: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)
Change of generalized anxiety symptoms assessed by the Generalized Anxiety Disorder 7 (GAD-7; Löwe et al., 2008) questionnaire
Total score ranging from 7 - 35 (representing the sum of each of the 7 individual items). Lower scores represent less anxiety and a more favourable outcome.
Measured: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)
Change in depressive symptoms assessed by the Patient Health Questionnaire-9 for Adolescents (PHQ-A; Johnson et al., 2002)
Total score ranging from 0 - 27 (representing the sum of each of the 9 individual items). Lower scores represent less depressive symptoms and a more favourable outcome.
Measured: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)
Change in health-related quality of life assessed by the KIDSCREEN-10 (Ravens-Sieberer et al., 2010)
Total score ranging from 11 - 55 (representing the sum of each of the 11 individual items). Higher scores represent a higher quality of life and a more favourable outcome.
Measured: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)
Change in self-esteem assessed by the Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965)
Total score ranging from 0 - 30 (representing the sum of each of the 10 individual items). Higher scores represent a higher self-esteem and a more favourable outcome.
Measured: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)
Change in social anxiety assessed by the Social Phobia Inventory (SPIN; Connor et al., German Version: Sosic et al., 2008)
Measure of social anxiety, total score ranging from 0 - 68 (representing the sum of each of the 17 individual items). Lower scores represent less social anxiety and a more favourable outcome.
Measured: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 202131 Mar 2024

First posted4 Mar 2021
Study start7 Jun 2021
Primary completion31 Dec 2023
Study completion31 Mar 2024

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 AnxietyStudies of the same condition, open and under way.
More trials run by University of BernThe 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: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04782102
Sponsor's protocol ID: 2020-02501
Acronym: SOPHIE
Status last verified: Jun 2024
First submitted: 1 Mar 2021
Last updated: 4 Jun 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Walder N, Berger T, Schmidt SJ. Prevention and Treatment of Social Anxiety Disorder in Adolescents: Protocol for a Randomized Controlled Trial of the Online Guided Self-Help Intervention SOPHIE. JMIR Res Protoc. 2023 Jun 21;12:e44346. doi: 10.2196/44346.
PubMed 37342086

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Social Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SOPHIE: a Randomised Controlled Trial to Investigate the Efficacy of Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents
ClinicalTrials.gov ID: NCT04782102
Acronym / sponsor ID: SOPHIE / 2020-02501
Conditions: Social Anxiety, Social Anxiety Disorder
Keywords: Prevention, Intervention, Adolescents, Youths, Online-Intervention, Internet-Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: University of BernUniversity, hospital or other
Study start: 7 Jun 2021 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 4 Mar 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SOPHIE Intervention	Experimental	Behavioral: SOPHIE InterventionSOPHIE is an online-intervention aiming to reduce social anxiety in adolescents. SOPHIE has 8 modules, one module per week, which lasts about 60 minutes. SOPHIE includes elements of evidence-based psychotherapeutic interventions to reduce social anxiety and of an existing online-intervention for adults with social anxiety adopted to the needs of adolescents. The intervention consists of psychoeducation (how social anxieties arise), application examples (e.g. setting up a personal anxiety cycle or anxiety pyramid, imagination exercise: journey to a safe place), and contains weekly tasks for which regular repetition in everyday life is important (e.g. progressive muscle relaxation, observing anxiety in everyday life, exposures in various situations). At the end of each module, a short quiz allows participants to recall and consolidate what they have learned. The content is presented in video inputs, short explanatory texts, application tasks and quizzes.
Care-as-usual	No intervention	–Care-As-Usual: all other kinds of interventions are allowed and will be recorded using the Client Sociodemographic and Service Receipt Inventory (Chisholm et al., 2000; Roick et al., 2001)

Who may qualify

Ages: 11 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Age between 11;00 (11 years and 0 months) and 17;11 (17 years and 11 months)
Good written and spoken German language skills
Access to an Internet connection and a device to use the intervention (tablet, smartphone, PC) and to collect the EMA data (smartphone)
Subclinical values on the SPIN (value: 16-23; Loscalzo et al., 2018) or criteria for social anxiety disorder according to Kinder-DIPS (Schneider et al., 2017)
Written consent of the adolescent (if at least 14 years old) or the parents or guardian (if adolescent under 14 years old) and assent of adolescent under 14 years old

Key exclusion criteria (4 listed)

Known diagnosis of autism spectrum disorder
Current suicidal ideation (collected via PHQ-A Item 9)
Lack of knowledge of the German language in spoken and written form
Past diagnosis of social anxiety according to the DSM-5 criteria assessed by the Kinder-DIPS (Schneider et al., 2017) in participants with current subclinical anxiety

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
SOPHIE InterventionSOPHIE is an online-intervention aiming to reduce social anxiety in adolescents. SOPHIE has 8 modules, one module per week, which lasts about 60 minutes. SOPHIE includes elements of evidence-based psychotherapeutic interventions to reduce social anxiety and of an existing online-intervention for adults with social anxiety adopted to the needs of adolescents. The intervention consists of psychoeducation (how social anxieties arise), application examples (e.g. setting up a personal anxiety cycle or anxiety pyramid, imagination exercise: journey to a safe place), and contains weekly tasks for which regular repetition in everyday life is important (e.g. progressive muscle relaxation, observing anxiety in everyday life, exposures in various situations). At the end of each module, a short quiz allows participants to recall and consolidate what they have learned. The content is presented in video inputs, short explanatory texts, application tasks and quizzes.	Behavioural	SOPHIE Intervention

Primary outcome

Change in social anxiety assessed by the Social Phobia Inventory (SPIN; Connor et al., German Version: Sosic et al., 2008)
Time frame: Baseline assessment compared to assessment at post-intervention (2 months after baseline)
Measure of social anxiety, total score ranging from 0 - 68 (representing the sum of each of the 17 individual items). Lower scores represent less social anxiety and a more favourable outcome.

10 secondary outcomes

Current and past mental disorder assessed by the structured diagnostic interview for mental disorders of childhood and adolescence (Kinder-DIPS; Schneider et al., 2017)
Time frame: Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention);
Change in global functioning assessed by the GF Social (Cornblatt et al., 2007)
Time frame: Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention)
Change in global functioning assessed by the GF Role Scale (Cornblatt et al., 2007)
Time frame: Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention)
Utilisation of help assessed by the Client Sociodemographic and Service Receipt Inventory (CSSRI-EU; Chisholm et al., 2000; Roick et al., 2001)
Time frame: Assessed at post-intervention (2 months after baseline) and follow-up (5 months after baseline)
Change of fear of negative evaluation and avoidance assessed by the Social Anxiety Scale for Adolescents (SAS-A; La Greca & Lopez,1998)
Time frame: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)
Change of generalized anxiety symptoms assessed by the Generalized Anxiety Disorder 7 (GAD-7; Löwe et al., 2008) questionnaire
Time frame: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)
Change in depressive symptoms assessed by the Patient Health Questionnaire-9 for Adolescents (PHQ-A; Johnson et al., 2002)
Time frame: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)
Change in health-related quality of life assessed by the KIDSCREEN-10 (Ravens-Sieberer et al., 2010)
Time frame: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)
Change in self-esteem assessed by the Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965)
Time frame: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)
Change in social anxiety assessed by the Social Phobia Inventory (SPIN; Connor et al., German Version: Sosic et al., 2008)
Time frame: Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline)

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 4 Jun 2024.
Derived from this study: PubMed 37342086Walder N, Berger T, Schmidt SJ. Prevention and Treatment of Social Anxiety Disorder in Adolescents: Protocol for a Randomized Controlled Trial of the Online Guided Self-Help Intervention SOPHIE. JMIR Res Protoc. 2023 Jun 21;12:e44346. doi: 10.2196/44346.
Website of the online-intervention SOPHIELink provided by the sponsor.
Individual participant dataSharing planned: Yes

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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.

Stefanie J Schmidt, Prof. Dr. principal investigator

University of Bern

Thomas Berger, Prof. Dr. study chair

University of Bern

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SOPHIE Intervention in people with Social Anxiety and Social Anxiety Disorder, run by University of Bern at 1 site in Switzerland.

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 4 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 4 Jun 2024. 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 Switzerland. 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?

Change in social anxiety assessed by the Social Phobia Inventory (SPIN; Connor et al., German Version: Sosic et al., 2008) (time frame: Baseline assessment compared to assessment at post-intervention (2 months after baseline)). 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 NCT04782102, 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 4 Jun 2024.