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
© The Author(s). 2018
- Received: 16 March 2018
- Accepted: 2 August 2018
- Published: 14 August 2018
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.
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