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

NCT04782102 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-06-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Bern

    lead OTHER

Principal Investigators

  • Stefanie J Schmidt, Prof. Dr. · University of Bern

  • Thomas Berger, Prof. Dr. · University of Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2023-12-31
Completion
2024-03-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04782102 on ClinicalTrials.gov