Telemedicine Cognitive Behavioral Therapy for Anxiety After Stroke: Proof-of-Concept Randomized Controlled Trial

Abstract

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.

Keywords: anxiety; psychotherapy; stroke; telemedicine; workflow.

Figures

Figure 1.

Consort flow diagram. TIA indicates transient ischemic attack.

Figure 2.

Anxiety data by treatment group at week 6 and week 20 post-randomization. Open dots represent data points. Box is interquartile range (IQR). Upper whisker extends from third quartile to the largest value no further than 1.5×IQR. Lower whiskers extends from first quartile to the smallest value at most 1.5×IQR. Data beyond the whiskers are outliers. FQ indicates fear questionnaire; and GAD-7, 7-item generalized anxiety disorder questionnaire.

Figure 3.

Summary actigraphy data extracted from a GENEactiv sensor.A, Summary of actigraphy data of a randomly selected participant (3-dimensional acceleration, wrist-temperature, and light) to illustrate data presentation. The vertical green transparent colour indicates automatically estimated sleep times. Transparent brown indicates nonwear times. B, Actogram plot for a randomly selected participant to illustrate data presentation. Green transparent colour indicates automatically estimated sleep times. Transparent brown indicates nonwear times. TIA indicates transient ischemic attack.

Figure 4.

Activity and sleep measures between TASK-CBT and TASK-Relax at 20 wk post-randomization. IS indicates inter-daily stability; IV, intradaily variability; L5, least average activity over 5 consecutive hours in a 24-h day; M10, maximum average activity over 10 consecutive hours in a 24-h day; MDA, mean diurnal activity; MNA, mean nocturnal activity; 50th percentile sleep activity; sleep duration; and RA, relative amplitude.