Chronic SchizophreniaNCT01761383
Role of Nintendo Wii in Improving Negative Symptoms and Quality of Life in Chronic Schizophrenia
A study testing Nintendo Wii video console and Nintendo Wii Fit Plus games in people with Chronic Schizophrenia, run by Queen's University at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether the use of Nintendo Wii will help improve negative symptoms of Schizophrenia and quality of life of patients with chronic Schizophrenia. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Chronic Schizophrenia
- What is being tested?
- Nintendo Wii video console and Nintendo Wii Fit Plus games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jan 2015
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of violence or other risks that may endanger study research assistants during home visits
Trial locations and contacts
1 site in 1 country.
Canada1 site
Community High Intensity Treatment Team (CHITT) at Providence Care Mental Health Services
Kingston, Ontario, K7L 4X3
About this study
Official title: Nintendo Wii and Schizophrenia. A Pilot Study.
The purpose of this study is to determine whether the use of Nintendo Wii will help improve negative symptoms of Schizophrenia and quality of life of patients with chronic Schizophrenia.
Read the 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.
- Conditions
- Chronic Schizophrenia
- Being tested
- Nintendo Wii video console and Nintendo Wii Fit Plus games
- Keywords
- Chronic Schizophrenia, Nintendo Wii, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Wii video console and Nintendo Wii Fit Plus gamesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nintendo Wii and Chronic Schizophrenia | Experimental | 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. Receives: Other: Nintendo Wii video console and Nintendo Wii Fit Plus games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life.
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.
Measured: 6 months
Secondary outcomes (2)
Weight.
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.
Measured: 6 months
Subjective overall functioning.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SchizophreniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Walmart
- Responsible party
- Principal investigator, Dr. Martin Feakins, Queen's University
- Investigators
- Martin Feakins, M.D., Principal investigator, Department of Psychiatry at Queen's University, Kingston, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761383
- Sponsor's protocol ID
- 6006092
- Status last verified
- Feb 2016
- First submitted
- 1 Nov 2012
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nintendo Wii and Schizophrenia. A Pilot Study.
- ClinicalTrials.gov ID
- NCT01761383
- Acronym / sponsor ID
- 6006092
- Conditions
- Chronic Schizophrenia
- Keywords
- Chronic Schizophrenia, Nintendo Wii, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Walmart
- Study start
- Jun 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 4 Jan 2013 (estimated)
- 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.
The purpose of this study is to determine whether the use of Nintendo Wii will help improve negative symptoms of Schizophrenia and quality of life of patients with chronic Schizophrenia.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nintendo Wii and Chronic Schizophrenia | Experimental | Other: Nintendo Wii video console and Nintendo Wii Fit Plus gamesParticipants 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- History of violence or other risks that may endanger study research assistants during home visits
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 |
|---|---|---|
| Nintendo Wii video console and Nintendo Wii Fit Plus gamesThe 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. | Other | Nintendo Wii and Chronic Schizophrenia |
Primary outcome
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.
2 secondary outcomes
Weight.
Time frame: 6 months
Subjective overall functioning.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- 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.
Martin Feakins, M.D. principal investigator
Department of Psychiatry at Queen's University, Kingston, Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nintendo Wii video console and Nintendo Wii Fit Plus games in people with Chronic Schizophrenia, run by Queen's University at 1 site in Canada.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 12 Feb 2016. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2016.