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Open Access Study protocol

Low-intensity internet-delivered treatment for generalized anxiety symptoms in routine care: protocol for a randomized controlled trial

Derek Richards12*, Ladislav Timulak2, Gavin Doherty3, John Sharry4, Orla McLoughlin5, Chuck Rashleigh5, Amy Colla1 and Ciara Joyce1

Author Affiliations

1 SilverCloud Health, The Priory, John’s Street West, Dublin 8, Ireland

2 School of Psychology, University of Dublin, Trinity College, Dublin 2, Ireland

3 School of Computer Science & Statistics, University of Dublin, Trinity College, Dublin 2, Ireland

4 Mater Misericordiae University Hospital, Eccles St., Dublin 7, Ireland

5 University of Dublin, Trinity College, Dublin 2, Ireland

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Trials 2014, 15:145  doi:10.1186/1745-6215-15-145

Published: 27 April 2014

Abstract

Background

Worldwide prevalence of generalized anxiety disorder (GAD) is considered high; in Europe lifetime prevalence has been estimated at 4.3 to 5.9%. High levels of anxiety disorders have been reported in university students, affecting 25 to 30% of the population. Young adults are some of the most vulnerable for the onset of mental health disorders and any stressors may act as a catalyst for their onset. The absence of resources can often mean that many do not seek treatment. Other factors that impede access to resources include such things as a lack of trained professionals, personal stigma, and waiting lists. Anxiety disorders can be treated successfully; indeed brief forms of cognitive-behavior therapy have been recommended. One potential avenue for research and development is that of delivering low-intensity interventions online for students with GAD. Therefore, the current study seeks to investigate the potential effectiveness for a low-intensity online CBT-based treatment for GAD in a service-based setting; implemented as one step in a stepped-care model.

Methods/Design

The research is a service-based effectiveness study utilizing a randomized waiting-list controlled design. The active intervention consists of six weekly modules of online CBT. Participants are assigned a supporter who provides weekly post-session feedback on progress and exercises. Participants will complete the GAD-7 as the primary outcome measure. Secondary outcomes include pathological worry, depression and measures of well-being. At three-months follow-up data will be collected using the GAD-7, BDI-II, PSWQ, ED-Q5 and WSAS. Post-session data will be collected on significant in-session events in treatment (HAT). A satisfaction with treatment measure will be administered post-treatment (SAT).

Discussion

The study will be a contribution to the potential for a low-intensity internet-delivered program implemented in a service-based setting; implemented as one step in a stepped-care model. The study will be a contribution to the already established work in online treatments for anxiety worldwide. The study will assess the utility of an innovative digital health solution (SilverCloud) to deliver such interventions.

Trial registration

Current Controlled Trials ISRCTN16303842.

Keywords:
Generalized anxiety disorder; Online interventions; Treatment; Students; CBT; Randomized trial