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

This secondary problem wouldn't need to be solved if you got your stroke patients 100% recovered with exact protocols and had diet protocols for stroke prevention. Solve the correct problem. 
https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-018-0329-x

• Ho-Yan Yvonne ChunEmail authorView ORCID ID profile,
• Alan J. Carson,
• Martin S. Dennis,
• Gillian E. Mead and
• William N. Whiteley

Pilot and Feasibility Studies20184:139

https://doi.org/10.1186/s40814-018-0329-x

©  The Author(s). 2018

• Received: 16 March 2018
• Accepted: 2 August 2018
• Published: 14 August 2018

Open Peer Review reports

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

• Telemedicine
• Web-enabled
• Cognitive behavioural therapy
• Stroke
• Anxiety
• Wearable

Background

There are more than 100,000 strokes per year and 1.2 million stroke survivors in the UK [1]. Anxiety affects a quarter of stroke patients [2], equivalent to around 25,000 patients per year. Anxiety is associated with dependence, poorer quality of life and restricted participation in work and social activities after even mild stroke and TIA [3].

Phobic and generalised anxiety

Anxiety is a universal emotion that helps people adapt to changing situations. However, it can become maladaptive when anxiety becomes pervasive or out-of-proportion to the danger posed by a situation. When maladaptive anxiety starts to interfere with a person’s occupational or social functioning, it is considered an anxiety disorder. Anxiety can be broadly divided into two clinical subtypes—phobic and generalised. Phobic anxiety is characterised by a disproportionate fear of well-defined situations or stimuli and marked avoidance of those situations [4]. By contrast, generalised anxiety disorder is diffuse and unremitting, characterised by persistent and multiple worries, e.g. finances, health and an inability to stop worrying [4]. In our recent prospective cohort, we found phobic disorder to be the predominant anxiety subtype after stroke and TIA [3].

What are stroke patients anxious about?

Patients with anxiety disorder reported more avoidance in agoraphobia-related situations, e.g. going out alone, going to crowded places and travelling on public transport; social situations and specific situations, e.g. physical exertion, having sex, being alone at home and activities related to fear of having a headache, another stroke or a fall [3]. In our recent study, we found that the fear of stroke recurrence is the most commonly reported anxiety-provoking thought post stroke/TIA. This fear appeared to have led to differential behaviours in our patients. In some, this anticipatory anxiety brought about a desire for better health and increased positive health behaviours, e.g. complying with medications and doctor’s advice on lifestyle, while others developed a grossly distorted view of their risk of stroke recurrence despite adhering to secondary prevention [3]. These patients feared having a debilitating stroke on a regular basis, perpetuating maladaptive avoidance of daily situations. Both avoidant behaviours and distorted thinking are targets for a CBT-based intervention.