iPad Application-based Intervention for Post-stroke Depression

Kibi International University

Status: Unknown

Conditions: Post-stroke Depression

Treatments: Behavioral: Usual rehabilitation; Device: iPad Application + Usual Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03864484

H30-038

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

iPad Application + Usual Rehabilitation

Experimental group

Description:

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

Treatment:

Device: iPad Application + Usual Rehabilitation

Usual rehabilitation

Active Comparator group

Description:

The control group receives usual rehabilitation.

Treatment:

Behavioral: Usual rehabilitation