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

University of Bern

Status: Completed

Conditions: Social Anxiety; Social Anxiety Disorder

Treatments: Behavioral: SOPHIE Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04782102

2020-02501

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

SOPHIE Intervention

Experimental group

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.

Treatment:

Behavioral: SOPHIE Intervention

Care-as-usual

No Intervention group

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)