NCT01761383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

2.6 years

First QC Date

November 1, 2012

Last Update Submit

February 11, 2016

Conditions

Chronic Schizophrenia

Keywords

Chronic SchizophreniaNintendo WiiQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (2)

  • Weight.

    6 months

  • Subjective overall functioning.

    6 months

Study Arms (1)

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.

Other: Nintendo Wii video console and Nintendo Wii Fit Plus games

Interventions

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.

Nintendo Wii and Chronic Schizophrenia

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of violence or other risks that may endanger study research assistants during home visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kingston, Ontario, K7L 4X3, Canada

Location

Study Officials

  • Martin Feakins, M.D.

    Department of Psychiatry at Queen's University, Kingston, Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator

Study Record Dates

First Submitted

November 1, 2012

First Posted

January 4, 2013

Study Start

June 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 12, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)