Back to resultsSOPHIE: Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents (SOPHIE)
Primary Purpose
Social Anxiety, Social Anxiety Disorder
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
SOPHIE Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety focused on measuring Prevention, Intervention, Adolescents, Youths, Online-Intervention, Internet-Intervention
Eligibility Criteria
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
Sites / Locations
- University of Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SOPHIE Intervention
Care-as-usual
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
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)
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04782102
Brief Title
SOPHIE: Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents
Acronym
SOPHIE
Official Title
SOPHIE: a Randomised Controlled Trial to Investigate the Efficacy of Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety, Social Anxiety Disorder
Keywords
Prevention, Intervention, Adolescents, Youths, Online-Intervention, Internet-Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SOPHIE Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Care-as-usual
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
SOPHIE Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in social anxiety assessed by the Social Phobia Inventory (SPIN; Connor et al., German Version: Sosic et al., 2008)
Description
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.
Time Frame
Baseline assessment compared to assessment at post-intervention (2 months after baseline)
Secondary Outcome Measure Information:
Title
Current and past mental disorder assessed by the structured diagnostic interview for mental disorders of childhood and adolescence (Kinder-DIPS; Schneider et al., 2017)
Description
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.
Time Frame
Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention);
Title
Change in global functioning assessed by the GF Social (Cornblatt et al., 2007)
Description
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
Time Frame
Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention)
Title
Change in global functioning assessed by the GF Role Scale (Cornblatt et al., 2007)
Description
Structured interview assessing the level of functioning in school / work ranging from 1 to 10, higher scores indicate a better level of functioning
Time Frame
Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention)
Title
Utilisation of help assessed by the Client Sociodemographic and Service Receipt Inventory (CSSRI-EU; Chisholm et al., 2000; Roick et al., 2001)
Description
Structured interview assessing the additional use of psychological, medical and other formal and informal services and sources of help (e.g. at school, friends)
Time Frame
Assessed at post-intervention (2 months after baseline) and follow-up (5 months after baseline)
Title
Change of fear of negative evaluation and avoidance assessed by the Social Anxiety Scale for Adolescents (SAS-A; La Greca & Lopez,1998)
Description
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.
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)
Title
Change of generalized anxiety symptoms assessed by the Generalized Anxiety Disorder 7 (GAD-7; Löwe et al., 2008) questionnaire
Description
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.
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)
Title
Change in depressive symptoms assessed by the Patient Health Questionnaire-9 for Adolescents (PHQ-A; Johnson et al., 2002)
Description
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.
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)
Title
Change in health-related quality of life assessed by the KIDSCREEN-10 (Ravens-Sieberer et al., 2010)
Description
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.
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)
Title
Change in self-esteem assessed by the Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965)
Description
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.
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)
Title
Change in social anxiety assessed by the Social Phobia Inventory (SPIN; Connor et al., German Version: Sosic et al., 2008)
Description
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.
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)
Other Pre-specified Outcome Measures:
Title
Adherence to the Online-Intervention
Description
Assessed within the online-intervention. Indicator of adherence: time spent in program.
Time Frame
During the eight-week online-intervention
Title
Adherence to the Online-Intervention
Description
Assessed within the online-intervention. Indicator of adherence: number of clicks.
Time Frame
During the eight-week online-intervention
Title
Adherence to the Online-Intervention
Description
Assessed within the online-intervention. Indicator of adherence: number of modules completed.
Time Frame
During the eight-week online-intervention
Title
Adherence to the Online-Intervention
Description
Assessed within the online-intervention. Indicator of adherence: number of exercises completed.
Time Frame
During the eight-week online-intervention
Title
Negative effects of the online-intervention
Description
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.
Time Frame
Assessed at post-intervention (2 months after baseline)
Title
Satisfaction with the online-intervention assessed by the Zufriedenheit mit der Intervention (ZUF-8; Schmidt et al., 1989) questionnaire
Description
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.
Time Frame
Assessed at post-intervention (2 months after baseline)
Title
Therapeutic alliance assessed by the Working Alliance Inventory for Guided Internet Interventions (WAI-I; Gómez Penedo et al., 2020)
Description
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.
Time Frame
Assessed 2, 4, 6, and 8 weeks after baseline (during the online-intervention every two weeks)
Title
Motivation of adolescent for the online-intervention assessed with the Motivation for Youth's Treatment Scale (MYTS; Breda & Riemer, 2012) youth version
Description
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.
Time Frame
Assessed at baseline and every two week during the eight week online-intervention (after 2, 4, 6, and 8 weeks)
Title
Motivation of parent / guardian for the online-intervention assessed with the Motivation for Youth's Treatment Scale (MYTS; Breda & Riemer, 2012) parent version
Description
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.
Time Frame
Baseline, mid-intervention(after 1 Month), and at post-intervention (after 2 months)
Title
Adolescents' expectation of the online-intervention assessed with the Credibility/Expectancies Questionnaire (CEQ; Devilly & Borkovec, 2000) youth version
Description
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.
Time Frame
Assessed at baseline
Title
Parents' / Guardians' expectation of the online-intervention assessed with the Credibility/Expectancies Questionnaire (CEQ; Devilly & Borkovec, 2000) parent version
Description
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.
Time Frame
Assessed at baseline
Title
Ecological Momentary Assessment (EMA)
Description
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).
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).
Title
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)
Description
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.
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)
Title
Interview with adolescents in the intervention group on satisfaction with the online intervention
Description
Qualitative Interview
Time Frame
Assessed at post-intervention (2 months after randomization)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefanie J Schmidt, Prof. Dr.
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Berger, Prof. Dr.
Organizational Affiliation
University of Bern
Official's Role
Study Chair
Facility Information:
Facility Name
University of Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
Links:
URL
https://selfhelp.psy.unibe.ch/sophie/homepage
Description
Website of the online-intervention SOPHIE
Learn more about this trial
SOPHIE: Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents
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