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

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

Research output: Contribution to JournalArticleAcademicpeer-review

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.

Original languageEnglish
Article number197
Pages (from-to)1-12
Number of pages12
JournalBMC Psychiatry
Volume19
DOIs
Publication statusPublished - 25 Jun 2019

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Cost-Benefit Analysis
Randomized Controlled Trials
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Therapeutics
Social Phobia
Interpersonal Relations
Administrative Personnel
Anxiety
Quality of Life
Clinical Trials
Interviews
Depression
Control Groups
Health

Keywords

  • Economic evaluation
  • Internet-based treatment
  • Randomized controlled trial
  • Self-help
  • Social anxiety disorder
  • Social phobia
  • Unguided self-help
  • University students

Cite this

Kählke, Fanny ; Berger, Thomas ; Schulz, Ava ; Baumeister, Harald ; Berking, Matthias ; Cuijpers, Pim ; Bruffaerts, Ronny ; Auerbach, Randy P. ; Kessler, Ronald C. ; Ebert, David Daniel. / 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. In: BMC Psychiatry. 2019 ; Vol. 19. pp. 1-12.
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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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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. / Kählke, Fanny; Berger, Thomas; Schulz, Ava; Baumeister, Harald; Berking, Matthias; Cuijpers, Pim; Bruffaerts, Ronny; Auerbach, Randy P.; Kessler, Ronald C.; Ebert, David Daniel.

In: BMC Psychiatry, Vol. 19, 197, 25.06.2019, p. 1-12.

Research output: Contribution to JournalArticleAcademicpeer-review

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AU - Baumeister, Harald

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AU - Cuijpers, Pim

AU - Bruffaerts, Ronny

AU - Auerbach, Randy P.

AU - Kessler, Ronald C.

AU - Ebert, David Daniel

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