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Open Access 01-12-2019 | Social Anxiety Disorder | Study protocol

Efficacy and cost-effectiveness of an unguided, internet-based self-help intervention for social anxiety disorder in university students: protocol of a randomized controlled trial

Authors: Fanny Kählke, Thomas Berger, Ava Schulz, Harald Baumeister, Matthias Berking, Pim Cuijpers, Ronny Bruffaerts, Randy P. Auerbach, Ronald C. Kessler, David Daniel Ebert

Published in: BMC Psychiatry | Issue 1/2019

Abstract

Background

Social anxiety disorder (SAD) is highly prevalent among university students, but the majority of affected students remain untreated. Internet- and mobile-based self-help interventions (IMIs) may be a promising strategy to address this unmet need. This study aims to investigate the efficacy and cost-effectiveness of an unguided internet-based treatment for SAD among university students. The intervention is optimized for the treatment of university students and includes one module targeting fear of positive evaluations that is a neglected aspect of SAD treatment.

Methods

The study is a two arm randomized controlled trial in which 200 university students with a primary diagnosis of SAD will be assigned randomly to either a wait-list control group (WLC) or the intervention group (IG). The intervention consists of 9 sessions of an internet-based cognitive-behavioral treatment, which also includes a module on fear of positive evaluation (FPE). Guidance is delivered only on the basis of standardized automatic messages, consisting of positive reinforcements for session completion, reminders, and motivational messages in response to non-adherence. All participants will additionally have full access to treatment as usual. Diagnostic status will be assessed through Structured Clinical Interviews for DSM Disorders (SCID). Assessments will be completed at baseline, 10 weeks and 6-month follow-up. The primary outcome will be SAD symptoms at post-treatment, assessed via the Social Phobia Scale (SPS) and the Social Interaction Anxiety Scale (SIAS). Secondary outcomes will include diagnostic status, depression, quality of life and fear of positive evaluation. Cost-effectiveness and cost-utility analyses will be evaluated from a societal and health provider perspective.

Discussion

Results of this study will contribute to growing evidence for the efficacy and cost-effectiveness of unguided IMIs for the treatment of SAD in university students. Consequently, this trial may provide valuable information for policy makers and clinicians regarding the allocation of limited treatment resources to such interventions.

Trial registration

DRKS00011424 (German Clinical Trials Register (DRKS)) Registered 14/12/2016.

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Title: Efficacy and cost-effectiveness of an unguided, internet-based self-help intervention for social anxiety disorder in university students: protocol of a randomized controlled trial
Authors: Fanny Kählke
Thomas Berger
Ava Schulz
Harald Baumeister
Matthias Berking
Pim Cuijpers
Ronny Bruffaerts
Randy P. Auerbach
Ronald C. Kessler
David Daniel Ebert
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Social Anxiety Disorder
Anxiety
Published in: BMC Psychiatry / Issue 1/2019
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-019-2125-4

At a glance: The STEP trials

Springer Medicine

Efficacy and cost-effectiveness of an unguided, internet-based self-help intervention for social anxiety disorder in university students: protocol of a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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