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

NCT04782102 | Completed DMC

• 1 other identifier: 2020-02501
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety; Social Anxiety Disorder

Keywords

Prevention; Intervention; Adolescents; Youths; Online-Intervention; Internet-Intervention

Outcome Measures

Primary Outcomes (1)

• 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 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)

  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)

  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)

  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)

  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)

  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 Outcomes (14)

• Adherence to the Online-Intervention

  During the eight-week online-intervention

• Adherence to the Online-Intervention

  During the eight-week online-intervention

• Adherence to the Online-Intervention

  During the eight-week online-intervention

Study Arms (2)

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.

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)

Interventions

SOPHIE Intervention BEHAVIORAL

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.

SOPHIE Intervention

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University of Bern

Bern, 3012, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 37342086 DERIVED

Related Links

• Website of the online-intervention SOPHIE

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Stefanie J Schmidt, Prof. Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

• Thomas Berger, Prof. Dr.

  University of Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: June 7, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)