iPad Application-based Intervention for Post-stroke Depression

NCT ID: NCT03864484

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-07

Study Completion Date

2022-03-30

Brief Summary

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We plan to conduct a randomized controlled trial to examine whether usual rehabilitation plus an iPad application-based intervention improves post-stroke depression symptoms compared to usual rehabilitation alone.

The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.

Detailed Description

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Conditions

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Post-stroke Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iPad Application + Usual Rehabilitation

The experimental group receives usual rehabilitation. In addition, participants watch a video using the iPad Application displaying positive word stimuli.

Group Type EXPERIMENTAL

iPad Application + Usual Rehabilitation

Intervention Type DEVICE

The experimental group receives usual rehabilitation. In addition, the experimental group will watch movies using the iPad application for 3 minutes, once daily for 5 weeks.

Usual rehabilitation

The control group receives usual rehabilitation.

Group Type ACTIVE_COMPARATOR

Usual rehabilitation

Intervention Type BEHAVIORAL

The control group receives usual rehabilitation.

Interventions

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iPad Application + Usual Rehabilitation

The experimental group receives usual rehabilitation. In addition, the experimental group will watch movies using the iPad application for 3 minutes, once daily for 5 weeks.

Intervention Type DEVICE

Usual rehabilitation

The control group receives usual rehabilitation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 40 years and older
* Males and females
* Center for Epidemiologic Studies Depression Scale score ≥16
* Mini Mental State Examination score ≥ 24
* First stroke
* Native language is Japanese
* Written informed consent prior to participation

Exclusion Criteria

* Major depressive disorder before onset of stroke
* Bilateral hemiplegia
* Vision or hearing deficits that negatively impact everyday life
* Severe aphasia
* Severe unilateral spatial neglect
* Diagnosis of neurodegenerative disease such as Parkinson's disease or multiple system atrophy
* Current life-threatening severe organ failure, musculoskeletal disorders, or cancer
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kibi International University

OTHER

Sponsor Role lead

Responsible Party

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Kazuki Hirao, PhD, OT

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kazuki Hirao, PhD

Role: PRINCIPAL_INVESTIGATOR

Kibi International University

Locations

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Kurashiki Heisei Hospital

Kurashiki, Okayama-ken, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Hiroyuki Uchida

Role: CONTACT

+81-86-427-1111

Facility Contacts

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Hiroyuki Uchida

Role: primary

+81-86-427-1111

References

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Ejiri H, Uchida H, Tsuchiya K, Fujiwara K, Kikuchi S, Hirao K. Effects of Smartphone-Delivered Positive-Word Stimulation on Depressed Mood in People with Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial. Neuropsychiatr Dis Treat. 2021 Aug 20;17:2739-2748. doi: 10.2147/NDT.S323126. eCollection 2021.

Reference Type DERIVED
PMID: 34456565 (View on PubMed)

Other Identifiers

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H30-038

Identifier Type: -

Identifier Source: org_study_id

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