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Role of Nintendo Wii in Improving Negative Symptoms and Quality of Life in Chronic Schizophrenia

Primary Purpose

Chronic Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nintendo Wii video console and Nintendo Wii Fit Plus games
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Schizophrenia focused on measuring Chronic Schizophrenia, Nintendo Wii, Quality of Life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Community High Intensity Treatment Team (CHITT) at Providence Care Mental Health Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nintendo Wii and Chronic Schizophrenia

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 1, 2012
Last Updated
February 11, 2016
Sponsor
Queen's University
Collaborators
Walmart
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1. Study Identification

Unique Protocol Identification Number
NCT01761383
Brief Title
Role of Nintendo Wii in Improving Negative Symptoms and Quality of Life in Chronic Schizophrenia
Official Title
Nintendo Wii and Schizophrenia. A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Walmart

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Schizophrenia
Keywords
Chronic Schizophrenia, Nintendo Wii, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nintendo Wii and Chronic Schizophrenia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nintendo Wii video console and Nintendo Wii Fit Plus games
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Weight.
Description
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.
Time Frame
6 months
Title
Subjective overall functioning.
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Feakins, M.D.
Organizational Affiliation
Department of Psychiatry at Queen's University, Kingston, Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community High Intensity Treatment Team (CHITT) at Providence Care Mental Health Services
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 4X3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Nintendo Wii in Improving Negative Symptoms and Quality of Life in Chronic Schizophrenia

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