Treating anxiety after stroke (TASK): the feasibility phase of a novel web-enabled randomised controlled trial

Ho-Yan Yvonne Chun, Alan J Carson, Martin S Dennis, Gillian E Mead, William N Whiteley, Ho-Yan Yvonne Chun, Alan J Carson, Martin S Dennis, Gillian E Mead, William N Whiteley

Abstract

Background: Anxiety affects a quarter of strokes. It can be disabling even after mild stroke and transient ischaemic attack (TIA). It is not feasible to deliver conventional psychological therapies to the large population of anxious stroke and TIA patients. We are testing the feasibility of a web-enabled randomised controlled trial (RCT) to compare an individualised telemedicine cognitive behavioural therapy (CBT)-based intervention with a self-guided web-based relaxation programme. This study aims to evaluate the feasibility of novel trial procedures and the delivery of the TASK interventions in stroke and TIA patients.

Methods: We aim to recruit 40 community-based stroke and TIA patients experiencing anxiety at least 1 month post-discharge in Lothian, Scotland. We will assess the (1) recruitment number per month; (2) percentage completion of electronic consent; (3) time taken for remote eligibility confirmation; (4) percentage completion of follow-up surveys: modified Rankin scale, EuroQol-5D5L, 7-item generalised anxiety disorder, Patient Health Questionnaire-2 and modified fear questionnaire; (5) data capture of intervention fidelity and (6) use of actigraph smartwatches to obtain continuous data of rest/activity.

Discussion: The current study will provide feasibility data on streamlined web-enabled trial procedures and the use of smartwatches to obtain objective measures in stroke and TIA patients, offering potential for large efficient RCTs to be conducted centrally and remotely with far fewer resources in the future. This study will inform further refinements of the TASK interventions before evaluation in a definitive RCT.

Trial registration: Clinicaltrials.gov NCT03439813. Retrospectively registered on 20/2/2018.

Keywords: Anxiety; Cognitive behavioural therapy; Stroke; Telemedicine; Wearable; Web-enabled.

Conflict of interest statement

The TASK feasibility trial received a favourable opinion from the local research ethics committee (Additional file 6). All participants provided written informed consent.Not Applicable.AJC is a paid associate editor of the Journal of Neurology, Neurosurgery and Psychiatry and is involved in two not-for-profit websites: www.neurosymptoms.org and www.headinjurysymptoms.org. He holds a small grant £10,000 from the Health Technology Assessment in the United Kingdom to develop an app to deliver cognitive behavioural therapy after mild traumatic brain injury. This grant is shared with commercial partners. He has given independent testimony in court on a range of neuropsychiatric topics including anxiety after stroke. Other authors have declared that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Modelling processes and outcomes of TASK-CBT
Fig. 2
Fig. 2
TASK feasibility trial schematic
Fig. 3
Fig. 3
TASK-CBT content

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