Video Games Among People With Schizophrenia

NCT03133143 | Completed

• 1 other identifier: HSEARS20161228002
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 9

Brief Summary

The investigators aim to establish a research project to test the impact of gaming by carrying out a digital gaming interventions, monitoring its cognitive and clinical outcomes, while concurrently performing a multimodal brain imaging experiment.

Conditions

Cognitive Function; Schizophrenia and Disorders With Psychotic Features

Keywords

Cognitive Function; Schizophrenia and Disorders with Psychotic Features; Computers, Digital

Outcome Measures

Primary Outcomes (1)

• Verbal working memory function at 3-month and 6-month follow-ups

  Measured by Letter-number-span task from Wechsler Memory Scale III (WMS III), simplified/traditional Chinese versions. The instrument includes the National Institute of Mental Health - Measurement and Treatment Research to Improve Cognition in Schizophrenia 50 battery (NIMH-MATRICS50).

  3-month and 6-month follow-ups

Secondary Outcomes (18)

• Cognitive functioning: speed of processing

  Baseline, after intervention (three months) and at six months follow-up

• Cognitive functioning: attention

  Baseline, after intervention (three months) and at six months follow-up

• Cognitive functioning: vigilance

  Baseline, after intervention (three months) and at six months follow-up

• Cognitive functioning: visuo-spatial working memory

  Baseline, after intervention (three months) and at six months follow-up

• Cognitive functioning: reasoning

  Baseline, after intervention (three months) and at six months follow-up

Study Arms (3)

Cognifit

EXPERIMENTAL

Participants are instructed to play CogniFit 45-60 minutes, 5 days/week. A minimum of 50 gaming hours will be acquired to ensure observable neuroplasticity in the brain after gaming.

Behavioral: Cognifit

SIMS 4 (Maxis, Inc)

ACTIVE COMPARATOR

Participants are instructed to play SIMS 4 45-60 minutes, 5 days/week. A minimum of 50 gaming hours will be acquired to ensure observable neuroplasticity in the brain after gaming.

Behavioral: SIMS 4 (Maxis, Inc)

Treatment as usual

NO INTERVENTION

No specific intervention will be offered to those who receive treatment as usual according to their treatment schedule. The participants are encouraged not to play video games during the study period.

Interventions

Cognifit BEHAVIORAL

CogniFit is an Internet browser-based digital brain training program, to improve cognitive abilities based on a personalised brain training regimen. Participants are instructed to play all games assigned by cognifit from three categories (memory, spatial perception, and mental planning) during each training session. After playing the games in these three categories, they are free to choose which exercises they wish to play.

Cognifit

SIMS 4 (Maxis, Inc) BEHAVIORAL

The Sims 4 is a life simulation PC game. It is purely an entertainment game without known cognitive or health-related outcomes. Does not iclude high-intensity action and competition. This specific game and non-competitive games like it in general do not improve attention, working memory, or other cognitive abilities despite being engaging and fun.

SIMS 4 (Maxis, Inc)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients' diagnoses of schizophrenia (Diagnostic and Statistical Manual DSM-IV)
• able to speak Cantonese
• be unfamiliar with video games or at least non-active game players (play \< 5h/week)
• have the ability to provide written informed consent
• be viewed as being able to safely take part and have the cognitive status deemed suitable for participation (assessed by a chief psychiatrist based on his/her clinical expertise)

You may not qualify if:

• meeting diagnostic criteria for a current major depressive, manic or hypomanic episode (DSM-IV), or mental retardation
• having severe visual impairment
• being an active game player (i.e. gaming \> 5 h/week)
• displaying a lack of ability to decide their own participation
• displaying substance abuse (other than nicotine dependence)
• having head injury, hemiplegia, or other neurological disorders
• having had an Electroconvulsive Therapy (ECT) in the past six months
• having a lack of Magnetic Resonance Imaging (MRI) compatibility (for example, patients with cardiac pacemakers, metallic implants, restless behaviour)
• pregnancy

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• University of Helsinki: collaborator
• University of Turku: collaborator
• Kowloon Hospital, Hong Kong: collaborator
• Pamela Youde Nethersole Eastern Hospital: collaborator
• Maxgrace Fuller House: collaborator
• The Mental Health Association of Hong Kong: collaborator
• Sichuan University: collaborator

Study Sites (9)

Comfort Rehabilitation Home

Hong Kong, Hong Kong

Location

Everbright Rehabilitation Centre

Hong Kong, Hong Kong

Location

Home of Treasure

Hong Kong, Hong Kong

Location

Kowloon Hospital

Hong Kong, Hong Kong

Location

Mental Health Association of Hong Kong

Hong Kong, Hong Kong

Location

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

Parklane Rehabilitation Home

Hong Kong, Hong Kong

Location

Richmond Fellowship of Hong Kong

Hong Kong, Hong Kong

Location

Maxgrace Fuller House

Kowloon, Hong Kong

Location

Related Publications (1)

• Valimaki M, Yang M, Lam YTJ, Lantta T, Palva M, Palva S, Yee B, Yip SH, Yu KD, Chang HCC, Cheng PYI, Bressington D. The impact of video gaming on cognitive functioning of people with schizophrenia (GAME-S): study protocol of a randomised controlled trial. BMC Psychiatry. 2021 Jan 18;21(1):46. doi: 10.1186/s12888-020-03031-y.

  PMID: 33461506 BACKGROUND

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Maritta Välimäki, Professor

  Xiang Nursing School, Central South University; Hong Kong Polytechnic University; University of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The sequences of allocation will be concealed until interventions will be assigned. Allocation will not be masked to the researchers, who will recruit patients. Outcome assessors (who will not participate in patient randomisation or daily clinical treatment at the same unit) will be masked. The data analyst (the trial statistician) will be kept blinded to the allocation. Allocation: Randomized The trial manager will allocate the patient to one of the three arms of the trial based on a list of computer-generated random numbers (provided by an external clinical trial randomisation service).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A controlled, single-blind clinical trial with a pragmatic, three-arm parallel-group design.

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 28, 2017
• Study Start: May 16, 2019
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (9)