- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01761383
Role of Nintendo Wii in Improving Negative Symptoms and Quality of Life in Chronic Schizophrenia
Nintendo Wii and Schizophrenia. A Pilot Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proposed study seeks to determine whether any benefit in daily functioning and quality of life can be gained from using the Nintendo Wii video game console in chronic mental illness, namely schizophrenia. There is a small research base on the use of the Wii console in elderly nursing home residents as a means of increasing mobility, with attendant benefits in areas such as falls, quality of life, and relief of subsyndromal depression. For individuals with schizophrenia, adjunct exercise therapy has been associated with gains in both psychiatric and physical symptoms. However, people with schizophrenia face physical and functional barriers in initiating and continuing organized activity programs. Thus, the Nintendo Wii Fit Plus interactive fitness video game is being proposed as a novel way of introducing and engaging people with schizophrenia in various forms of physical activity.
As the first study to assess the use of the Nintendo Wii in chronic mental illness, the purpose of this pilot study is to assess the feasibility and the capacity of the Nintendo Wii in improving the health and functioning of people with severe, chronic schizophrenia. Although it is hypothesized that Nintendo Wii use will lead to gains in these domains, the information gained from this study will be used to determine specific areas of benefit and to assess whether any observed differences in outcome measures are sufficient to warrant a full-scale study. Furthermore, this initial study aims to pilot the interview schedule, clarify wording on the questionnaires, ensure that all important areas have been covered by the questionnaires, and determine whether participants are capable of meeting the demands of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ontario
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Kingston, Ontario, Canada, K7L 4X3
- Community High Intensity Treatment Team (CHITT) at Providence Care Mental Health Services
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed with Schizophrenia defined by the DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision)
- Males or females aged 18 years of older
- Participate in the Community High Intensity Treatment Team (CHITT) out-patient program
- Certified by their physician to participate in physical activity
Exclusion Criteria:
- History of violence or other risks that may endanger study research assistants during home visits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Nintendo Wii and Chronic Schizophrenia
Participants enrolled in the study will be provided with the Nintendo Wii console and Nintendo Wii Fit Plus video games to use for the duration of the study (6 months) with no restrictions or limitations on the games participants are allowed to play or duration of play.
There will be 5 home visits over a 6-month period to evaluate Nintendo Wii use and assess patients'health, functioning and quality of life with the use of self report questionnaires and psychiatric assessment.
|
The intervention will be provision of Nintendo Wii console and Wii Fit Plus video games to use for the duration of the study with no restrictions or limitations on the games participants are allowed to play or duration of play.
There will be 5 home visits over a 6-month period to evaluate Nintendo Wii use and assess patients'health, functioning and quality of life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life.
Time Frame: 6 months
|
To assess whether any benefit in daily functioning and quality of life can be gained from using the Nintendo Wii video game console in people with chronic Schizophrenia.
Assessed with the use of Short Form (36 questions)self report Health Survey (SF-36), Global Assessment of Functioning (GAF) Scale and the Clinical Global Impression-Schizophrenia(CGI-SCH)Scale.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight.
Time Frame: 6 months
|
To assess whether the use of Nintendo Wii will help in weight reduction [assessed using Body Mass Index (BMI) calculations and weight measurements] in patients with Chronic Schizophrenia.
|
6 months
|
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Subjective overall functioning.
Time Frame: 6 months
|
To assess whether the use of Nintendo Wii will help to: reduce cigarette consumption, improve subjective quality of life and motivation [assessed using a self report Visual Analog Scale(VAS)] in patients with Chronic Schizophrenia.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Feakins, M.D., Department of Psychiatry at Queen's University, Kingston, Ontario, Canada
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6006092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Schizophrenia
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National Taipei University of Nursing and Health...CompletedPatients With Chronic SchizophreniaTaiwan
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University of Maryland, BaltimoreCompleted
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Hôpital le VinatierNantes University Hospital; Centre Hospitalier Henri Laborit; University Hospital... and other collaboratorsCompletedChronic SchizophreniaFrance
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Manhattan Psychiatric CenterNational Institute of Mental Health (NIMH); Albert Einstein College of MedicineUnknownChronic SchizophreniaUnited States
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All India Institute of Medical Sciences, BhubaneswarRecruitingChronic SchizophreniaIndia
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TsaoTun Psychiatric Center, Department of Health...RecruitingChronic SchizophreniaTaiwan
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Rongjun Hospital of Hebei Province Affiliated to...Completed
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Northwell HealthCompletedChronic SchizophreniaUnited States
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Newron Pharmaceuticals SPACompletedChronic SchizophreniaUnited States, India
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SunovionCompletedChronic SchizophreniaUnited States, Colombia, India, Ukraine, Russian Federation, Romania
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