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Open Access 01-12-2020 | Behavioural Therapy | Study protocol

Efficacy of digital cognitive behavioural therapy for symptoms of generalised anxiety disorder: a study protocol for a randomised controlled trial

Authors: J. Gu, C. B. Miller, A. L. Henry, C. A. Espie, M. L. Davis, R. Stott, R. Emsley, J. A. J. Smits, M. Craske, K. E. A. Saunders, G. Goodwin, J. R. Carl

Published in: Trials | Issue 1/2020

Abstract

Background

Generalised anxiety disorder (GAD) is a chronic and disabling condition with considerable personal and economic impact. Cognitive behavioural therapy (CBT) is a recommended psychological therapy for GAD; however, there are substantial barriers to accessing treatment. Digital CBT, in particular smartphone-delivered CBT, has the potential to improve accessibility and increase dissemination of CBT. Despite the emerging evidence of smartphone-based psychological interventions for reducing anxiety, effect size scores are typically smaller than in-person interventions, and there is a lack of research assessing the efficacy of smartphone-delivered digital interventions specifically for GAD.

Methods

In the DeLTA trial (DigitaL Therapy for Anxiety), we plan to conduct a parallel-group superiority randomised controlled trial examining the efficacy of a novel smartphone-based digital CBT intervention for GAD compared to a waitlist control. We aim to recruit 242 adults (aged 18 years or above) with moderate-to-severe symptoms of GAD. This trial will be conducted entirely online and will involve assessments at baseline (week 0; immediately preceding randomisation), mid-intervention (week 3), post-intervention (week 6; primary end point) and follow-up (week 10). The primary objective is to evaluate the efficacy of the intervention on GAD symptom severity compared to a waitlist control at post-intervention. Secondary objectives are to examine between-group effects on GAD at follow-up, and to examine the following secondary outcomes at both post-intervention and follow-up: 1) worry; 2) depressive symptoms; 3) wellbeing; 4) quality of life; and 5) sleep difficulty.

Discussion

This trial will report findings on the initial efficacy of a novel digital CBT intervention for GAD. Results have the potential to contribute towards the evidence base for digital CBT for GAD and increase the dissemination of CBT.

Trial registration

ISRCTN, ISRCTN12765810. Registered on 11 January 2019.

Available only for authorised users

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Title: Efficacy of digital cognitive behavioural therapy for symptoms of generalised anxiety disorder: a study protocol for a randomised controlled trial
Authors: J. Gu
C. B. Miller
A. L. Henry
C. A. Espie
M. L. Davis
R. Stott
R. Emsley
J. A. J. Smits
M. Craske
K. E. A. Saunders
G. Goodwin
J. R. Carl
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Behavioural Therapy
Anxiety Disorder
Anxiety
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-4230-6

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Efficacy of digital cognitive behavioural therapy for symptoms of generalised anxiety disorder: a study protocol for a randomised controlled trial

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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