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

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: Active, not recruiting
• Conditions: Social Anxiety; Social Anxiety Disorder
• Intervention / Treatment: Behavioral: SOPHIE Intervention

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noemi Walder, M Sc; Phone Number: +41316315419; Email: noemi.walder@psy.unibe.ch
• Study Contact Backup: Name: Stefanie J Schmidt, Prof. Dr.; Phone Number: +41 31 631 82 63; Email: stefanie.schmidt@psy.unibe.ch

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)	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

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)	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)	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)	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)	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)	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	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)	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)	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)	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)	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

Outcome Measure	Measure Description	Time Frame
Adherence to the 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	Assessed within the online-intervention. Indicator of adherence: number of clicks.	During the eight-week online-intervention
Adherence to the 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	Assessed within the online-intervention. Indicator of adherence: number of exercises completed.	During the eight-week online-intervention
Negative effects of the online-intervention	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	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)	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	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	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	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	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)	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)	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	Qualitative Interview	Assessed at post-intervention (2 months after randomization)

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Principal Investigator: Stefanie J Schmidt, Prof. Dr., University of Bern; Study Chair: Thomas Berger, Prof. Dr., University of Bern

Publications and helpful links

Helpful Links

• Website of the online-intervention SOPHIE

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Prevention; Intervention; Youths; Online-Intervention; Internet-Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID 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