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

BMC Psychiatry

  ^{1    2    3    3    4    4    5    6    7    8} 

[1] 0000 0001 0668 7884, grid.5596.f, Research Group Psychiatry, Department of Neurosciences, KU Leuven University, Leuven, Belgium;0000 0001 0726 5157, grid.5734.5, Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland;0000 0001 2107 3311, grid.5330.5, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Nägelsbachstrasse 25a, 91052, Erlangen, Germany;0000 0004 1754 9227, grid.12380.38, Department of Clinical, Neuro- and Developmental Psychology, Vrije University Amsterdam, Amsterdam, The Netherlands;0000 0004 1936 9748, grid.6582.9, Department of Clinical Psychology and Psychotherapy, University of Ulm, Ulm, Germany;000000041936754X, grid.38142.3c, Department for Health Care Policy, Harvard Medical School, Boston, MA, USA;0000000419368729, grid.21729.3f, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA;Division of Clinical Developmental Neuroscience, Sackler Institute, New York, NY, USA;Department of Experimental Psychopathology and Psychotherapy, University of Zürich, Psychiatric University Hospital, Zürich, Switzerland;

关键词: Social anxiety disorder;    Social phobia;    Randomized controlled trial;    Internet-based treatment;    Self-help;    Unguided self-help;    University students;    Economic evaluation;   

DOI  :  10.1186/s12888-019-2125-4

来源: publisher

【 摘 要 】

BackgroundSocial 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.MethodsThe 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.DiscussionResults 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 registrationDRKS00011424 (German Clinical Trials Register (DRKS)) Registered 14/12/2016.

【 授权许可】

CC BY