Background and Purpose:
Disabling
anxiety affects a quarter of stroke survivors but access to treatment
is poor. We developed a telemedicine model for delivering guided
self-help cognitive behavioral therapy (CBT) for anxiety after stroke
(TASK-CBT). We aimed to evaluate the feasibility of TASK-CBT in a
randomized controlled trial workflow that enabled all trial procedures
to be carried out remotely. In addition, we explored the feasibility of
wrist-worn actigraphy sensor as a way of measuring objective outcomes in
this clinical trial.
Methods:
We
recruited adult community-based stroke patients (n=27) and randomly
allocated them to TASK-CBT (n=14) or relaxation therapy (TASK-Relax), an
active comparator (n=13).
Results:
In
our sample (mean age 65 [±10]; 56% men; 63% stroke, 37% transient
ischemic attacks), remote self-enrolment, electronic signature,
intervention delivery, and automated follow-up were feasible. All
participants completed all TASK-CBT sessions (14/14). Lower levels of
anxiety were observed in TASK-CBT when compared with TASK-Relax at both
weeks 6 and 20. Mean actigraphy sensor wearing-time was 33 days (±15).
Conclusions:
Our
preliminary feasibility data from the current study support a larger
definitive clinical trial and the use of wrist-worn actigraphy sensor in
anxious stroke survivors.
REGISTRATION:
URL:
https://www.clinicaltrials.gov. Unique identifier: NCT03439813.
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