Post-stroke DepressionNCT03864484
iPad Application-based Intervention for Post-stroke Depression
A study testing iPad Application + Usual Rehabilitation and Usual rehabilitation in people with Post-stroke Depression, run by Kibi International University at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- iPad Application + Usual Rehabilitation and Usual rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 7 May 2019to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kurashiki Heisei Hospital
Kurashiki, Okayama-ken, 710-0826
Hiroyuki Uchida, +81-86-427-1111, hiroyukiuchida02@gmail.com
About this study
Official title: An iPad Application-based Intervention for Improving Post-stroke Depression Symptoms: A Pilot Randomized Controlled Trial
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.
- Conditions
- Post-stroke Depression
- Being tested
- iPad Application + Usual Rehabilitation, Usual rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPad Application + Usual RehabilitationDevice
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 rehabilitationBehavioural
The control group receives usual rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| iPad Application + Usual Rehabilitation | Experimental | The experimental group receives usual rehabilitation. In addition, participants watch a video using the iPad Application displaying positive word stimuli. Receives: Device: iPad Application + Usual Rehabilitation |
| Usual rehabilitation | Active comparator | The control group receives usual rehabilitation. Receives: Behavioral: Usual rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
Measured: Change from Baseline CES-D at 5 weeks
Secondary outcomes (4)
Health-related quality of life as measured by the 36-item short-form Medical Outcome Study Questionnaire (SF-36).
Measured: Change from Baseline SF-36 at 5 weeks
Activities of daily living as measured by Functional Independence Measure (FIM).
Measured: Change from Baseline FIM at 5 weeks
Dynamic standing balance as measured by Functional Reach Test (FRT).
Measured: Change from Baseline FRT at 5 weeks
Safety is defined as the proportion of patients who experience an intervention-related adverse event or any adverse event during the study.
Adverse events, whether or not considered causally related to the study intervention, include death and life-threatening illness or injury requiring prolonged hospitalization or resulting in persistent disability.
Measured: The period from the start of the intervention to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start7 May 2019
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kibi International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazuki Hirao, PhD, OT, Kibi International University
- Investigators
- Kazuki Hirao, PhD, Principal investigator, Kibi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864484
- Sponsor's protocol ID
- H30-038
- Status last verified
- Aug 2020
- First submitted
- 2 Mar 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34456565
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An iPad Application-based Intervention for Improving Post-stroke Depression Symptoms: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03864484
- Acronym / sponsor ID
- H30-038
- Conditions
- Post-stroke Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Kibi International UniversityUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iPad Application + Usual Rehabilitation | Experimental | Device: iPad Application + Usual RehabilitationThe experimental group receives usual rehabilitation. In addition, participants watch a video using the iPad Application displaying positive word stimuli. |
| Usual rehabilitation | Active comparator | Behavioral: Usual rehabilitationThe control group receives usual rehabilitation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 40 years and older
- Males and females
- Center for Epidemiologic Studies Depression Scale score ≥16
- Mini Mental State Examination score ≥ 24
- First stroke
Key exclusion criteria (7 listed)
- Major depressive disorder before onset of stroke
- Bilateral hemiplegia
- Vision or hearing deficits that negatively impact everyday life
- Severe aphasia
- Severe unilateral spatial neglect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPad Application + Usual RehabilitationThe 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. | Device | iPad Application + Usual Rehabilitation |
| Usual rehabilitationThe control group receives usual rehabilitation. | Behavioural | Usual rehabilitation |
Primary outcome
Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
Time frame: Change from Baseline CES-D at 5 weeks
4 secondary outcomes
Health-related quality of life as measured by the 36-item short-form Medical Outcome Study Questionnaire (SF-36).
Time frame: Change from Baseline SF-36 at 5 weeks
Activities of daily living as measured by Functional Independence Measure (FIM).
Time frame: Change from Baseline FIM at 5 weeks
Dynamic standing balance as measured by Functional Reach Test (FRT).
Time frame: Change from Baseline FRT at 5 weeks
Safety is defined as the proportion of patients who experience an intervention-related adverse event or any adverse event during the study.
Time frame: The period from the start of the intervention to 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 34456565Ejiri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuki Hirao, PhD principal investigator
Kibi International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPad Application + Usual Rehabilitation and Usual rehabilitation in people with Post-stroke Depression, run by Kibi International University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiroyuki Uchida (+81-86-427-1111, hiroyukiuchida02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score. (time frame: Change from Baseline CES-D at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.