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

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 inperson 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.

Efficacy of digital cognitive behavioral therapy for moderate‐to‐severe symptoms of generalized anxiety disorder: A randomized controlled trial

“…Detailed protocol information is available elsewhere (Gu et al, 2020). Briefly, assessments were captured online using Qualtrics (Qualtrics, 2019) and measured at baseline (Week 0), mid‐intervention (Week 3), post‐intervention (Week 6), and follow‐up (Week 10).…”

“…A sample size of 242 participants (121 per group) was required to detect a between‐group effect size of 0.5 with 90% power and a significance level of p = .05, accounting for 30% attrition (Gu et al, 2020). Due to a preponderance of females, recruitment was increased to include more people who identify as male and allow for a more representative sample of the GAD population (McLean, Asnaani, Litz, & Hofmann, 2011).…”

“…Apart from telephone calls, all aspects of the study, including screening, consent, assessment allocation, and delivery of the intervention were conducted online. The protocol has been published separately (Gu et al, 2020).…”

“…A sample size of 242 participants (121 per group) was required to detect a between-group effect size of 0.5 with 90% power and a significance level of p = .05, accounting for 30% attrition (Gu et al, 2020).…”

Investigating the needs and concerns of older adults with multimorbidity and their healthcare professionals for conceivable digital psychotherapeutic interventions

“…There is little evidence in human–computer interaction and design research on integrating interventions to address psychological distress alongside chronic disease management. Research has explored stand-alone mental health applications, typically with a focus on stress, for example, the needs and preferences of students in relation to self-tracking mental health data, 48 how to visualise sensor-based stress data for self-management 49 designing digital mindfulness technologies for stress management, 50 the use of digital cognitive behavioural therapy 51 and how to integrate digital and human therapy for the management of depression. 52 Furthermore, older adults are generally underrepresented in research exploring digital mental health interventions.…”