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

Social Anxiety Disorder Clinical Trial

— SOPHIE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04782102
• Other study ID #: 2020-02501
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety
• Social Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to the Online-Intervention	Assessed within the online-intervention. Indicator of adherence: time spent in program.	During the eight-week online-intervention
Other	Adherence to the Online-Intervention	Assessed within the online-intervention. Indicator of adherence: number of clicks.	During the eight-week online-intervention
Other	Adherence to the Online-Intervention	Assessed within the online-intervention. Indicator of adherence: number of modules completed.	During the eight-week online-intervention
Other	Adherence to the Online-Intervention	Assessed within the online-intervention. Indicator of adherence: number of exercises completed.	During the eight-week online-intervention
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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
Other	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
Other	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).
Other	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)
Other	Interview with adolescents in the intervention group on satisfaction with the online intervention	Qualitative Interview	Assessed at post-intervention (2 months after randomization)
Primary	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	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);
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Website of the online-intervention SOPHIE