Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01761383
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : February 12, 2016
Sponsor:
Collaborator:
Walmart
Information provided by (Responsible Party):
Dr. Martin Feakins, Queen's University

Tracking Information
First Submitted Date  ICMJE November 1, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date February 12, 2016
Study Start Date  ICMJE June 2012
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Nintendo Wii in Improving Negative Symptoms and Quality of Life in Chronic Schizophrenia
Official Title  ICMJE Nintendo Wii and Schizophrenia. A Pilot Study.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Schizophrenia
Intervention  ICMJE Other: Nintendo Wii video console and Nintendo Wii Fit Plus games
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 Arms  ICMJE 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.
Intervention: Other: Nintendo Wii video console and Nintendo Wii Fit Plus games
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2013)
5
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761383
Other Study ID Numbers  ICMJE 6006092
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Martin Feakins, Queen's University
Study Sponsor  ICMJE Queen's University
Collaborators  ICMJE Walmart
Investigators  ICMJE
Principal Investigator: Martin Feakins, M.D. Department of Psychiatry at Queen's University, Kingston, Ontario, Canada
PRS Account Queen's University
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP