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

June 3, 2024 updated by: University of Bern

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.

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.

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.
128

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3012
        • University of Bern

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

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: SOPHIE Intervention
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.
Behavioral: SOPHIE Intervention
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.
No Intervention: Care-as-usual
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 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
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.
Baseline assessment compared to assessment at post-intervention (2 months after baseline)

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
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);
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.
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)
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
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)
Structured interview assessing the level of functioning in school / work ranging from 1 to 10, higher scores indicate a better level of functioning
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)
Structured interview assessing the additional use of psychological, medical and other formal and informal services and sources of help (e.g. at school, friends)
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to the Online-Intervention
Time Frame: During the eight-week online-intervention
Assessed within the online-intervention. Indicator of adherence: time spent in program.
During the eight-week online-intervention
Adherence to the Online-Intervention
Time Frame: During the eight-week online-intervention
Assessed within the online-intervention. Indicator of adherence: number of clicks.
During the eight-week online-intervention
Adherence to the Online-Intervention
Time Frame: During the eight-week online-intervention
Assessed within the online-intervention. Indicator of adherence: number of modules completed.
During the eight-week online-intervention
Adherence to the Online-Intervention
Time Frame: During the eight-week online-intervention
Assessed within the online-intervention. Indicator of adherence: number of exercises completed.
During the eight-week online-intervention
Negative effects of the online-intervention
Time Frame: Assessed at post-intervention (2 months after baseline)
Assessed with the Inventar zur Erfassung Negativer Effekte in der Psychotherapie für Kinder (Kinder-INEP; Bieda et al., 2018). Total score ranging from -3 - 38 (representing the sum of each of the 15 individual items). Higher scores represent more negative effects of the online-intervention and a less favourable outcome.
Assessed at post-intervention (2 months after baseline)
Satisfaction with the online-intervention assessed by the Zufriedenheit mit der Intervention (ZUF-8; Schmidt et al., 1989) questionnaire
Time Frame: Assessed at post-intervention (2 months after baseline)
Total score ranging from 8 - 32 (representing the sum of each of the 8 individual items). Higher scores represent more satisfaction and a more favourable outcome.
Assessed at post-intervention (2 months after baseline)
Therapeutic alliance assessed by the Working Alliance Inventory for Guided Internet Interventions (WAI-I; Gómez Penedo et al., 2020)
Time Frame: Assessed 2, 4, 6, and 8 weeks after baseline (during the online-intervention every two weeks)
Total score ranging from 12 - 60 (representing the sum of each of the 12 individual items). Higher scores represent a higher working alliance and a more favourable outcome.
Assessed 2, 4, 6, and 8 weeks after baseline (during the online-intervention every two weeks)
Motivation of adolescent for the online-intervention assessed with the Motivation for Youth's Treatment Scale (MYTS; Breda & Riemer, 2012) youth version
Time Frame: Assessed at baseline and every two week during the eight week online-intervention (after 2, 4, 6, and 8 weeks)
Total score ranging from 8 - 40 (representing the sum of each of the 8 individual items). Higher scores represent more motivation and a more favourable outcome.
Assessed at baseline and every two week during the eight week online-intervention (after 2, 4, 6, and 8 weeks)
Motivation of parent / guardian for the online-intervention assessed with the Motivation for Youth's Treatment Scale (MYTS; Breda & Riemer, 2012) parent version
Time Frame: Baseline, mid-intervention(after 1 Month), and at post-intervention (after 2 months)
Total score ranging from 8 - 40 (representing the sum of each of the 8 individual items). Higher scores represent more motivation and a more favourable outcome.
Baseline, mid-intervention(after 1 Month), and at post-intervention (after 2 months)
Adolescents' expectation of the online-intervention assessed with the Credibility/Expectancies Questionnaire (CEQ; Devilly & Borkovec, 2000) youth version
Time Frame: Assessed at baseline
Total score ranging from 4 - 36 (representing the sum of each of the 4 individual items) and two items indicating percents from 0-100. Higher scores represent higher expectations of the online-intervention.
Assessed at baseline
Parents' / Guardians' expectation of the online-intervention assessed with the Credibility/Expectancies Questionnaire (CEQ; Devilly & Borkovec, 2000) parent version
Time Frame: Assessed at baseline
Total score ranging from 4 - 36 (representing the sum of each of the 4 individual items) and two items indicating percents from 0-100. Higher scores represent higher expectations of the online-intervention.
Assessed at baseline
Ecological Momentary Assessment (EMA)
Time Frame: 3 times a day during the eight week online-intervention, and three times a day for the two succeeding weeks after the follow-up assessment (5 months after baseline).
The Ecological Momentary Assessment consists of 20 short questions asking about the momentary social context, the momentary affect (Positive and negative affective schedule for children; PANAS-C; Ebesutani et al., 2012) and factors maintaining social anxiety (derived from the Social phobia weekly summary scale; SPWSS; Clark et al., 2003).
3 times a day during the eight week online-intervention, and three times a day for the two succeeding weeks after the follow-up assessment (5 months after baseline).
Change in parents' / guardians' assessment of their children's social anxieties assessed by the Elternfragebogen zu sozialen Ängsten im Kindes- und Jugendalter (ESAK, van Gemmeren 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)
Total score ranging from 18 - 72 (representing the sum of each of the 18 individual items). Lower scores represent less social anxiety and a more favorable outcome.
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)
Interview with adolescents in the intervention group on satisfaction with the online intervention
Time Frame: Assessed at post-intervention (2 months after randomization)
Qualitative Interview
Assessed at post-intervention (2 months after randomization)

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.
University of Bern

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: Stefanie J Schmidt, Prof. Dr., University of Bern
  • Study Chair: Thomas Berger, Prof. Dr., University of Bern

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.

Helpful Links

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.
June 7, 2021

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.
December 31, 2023

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.
March 31, 2024

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).
March 1, 2021

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.
March 1, 2021

First Posted (Actual)

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.
March 4, 2021

Study Record Updates

Last Update Posted (Estimated)

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 4, 2024

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 3, 2024

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, 2024

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.
  • 2020-02501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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