An iPad application-based intervention for improving post-stroke depression symptoms in a convalescent rehabilitation ward: A pilot randomized controlled clinical trial protocol

Hiroyuki Uchida; Yoshiya Hiragaki; Yuta Nishi; Shiori Nakahara; Junki Koumoto; Yusuke Onmyoji; Norimasa Fujimoto; Kazuho Kawakami; Masato Ishii; Kazuki Hirao

doi:10.1016/j.invent.2020.100340

An iPad application-based intervention for improving post-stroke depression symptoms in a convalescent rehabilitation ward: A pilot randomized controlled clinical trial protocol

Internet Interv. 2020 Aug 27:21:100340. doi: 10.1016/j.invent.2020.100340. eCollection 2020 Sep.

Affiliations

¹ Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan.
² Graduate School of Health Sciences, Gunma University, Maebashi, Japan.

Abstract

Background: Post-stroke depression (PSD) is a neuropsychiatric sequela that causes serious adverse effects on the prognosis of stroke patients. Our developed iPad application is a very innovative approach designed to improve participants' depressive symptoms by presenting positive words stimuli in a video. Although this application has fewer side effects than existing pharmacological and non-pharmacological interventions and is likely less burdensome for patients and caregivers, its efficacy for PSD has not been investigated. Here we present a pilot randomized controlled trial (RCT) protocol to investigate the therapeutic potential of this application intervention for PSD patients.

Methods: This study is designed as a 5-week, single-center, open-label, parallel-group, pilot RCT. Thirty-two patients with PSD will be randomly assigned to a combination of the iPad application and usual rehabilitation or usual rehabilitation alone (1:1 allocation ratio). The iPad application intervention lasts 3 min a day, and the usual rehabilitation lasts 3 h a day. The primary outcome is the change from baseline in The Center for Epidemiologic Studies Depression Scale score at the end of the 5-week intervention.

Discussion: This pilot RCT is the first study to investigate the potential of iPad application interventions to reduce depressive symptoms in PSD patients. This pilot RCT determines whether this is a viable and effective intervention and informs the design for a full-scale trial. If our hypothesis is correct, this trial can provide evidence to augment the standard practice of iPad application interventions to improve depressive symptoms in patients with PSD.

Keywords: API, Application Programming Interface; CBT, Cognitive Behavioral Therapy; CRW, Convalescent Rehabilitation Ward; Depression; Mobile applications; OT, Occupational Therapists; PSD, Post-stroke Depression; PT, Physical Therapists; RCT, Randomized Controlled Trial; Rehabilitation; SPSRS, Subliminal Priming with Supraliminal Reward Stimulation; ST, Speech Therapists; Stroke; rTMS, Repetitive Transcranial Magnetic Stimulation.