The Impact of Gaming on Functioning Among People With Schizophrenia

NCT ID: NCT05707689

Last Updated: 2023-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2025-01-30

Brief Summary

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The goal of this clinical trial is to test whether gaming intervention works well for persons with psychotic disorder. The main question to be answered is whether gaming works well in improving functioning, some other clinical outcomes or causing any adverse effects. Researchers will compare gaming group to usual care.

Detailed Description

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The overall goal of this study is to evaluate the effectiveness of gaming to improve functioning and clinical outcomes in people with psychotic disorders. Feasibility of the intervention will also be assessed. Our hypothesis are as follows:

Primary hypothesis:

1. Gaming is more effective on improving functioning 3- and/or 6-months follow-ups comparing to usual practices (TAU).

Secondary hypotheses:
2. Gaming is more effective on improving clinical outcomes and treatment acceptance (symptoms, self-efficacy, the quality of life, drop-out from intervention) at 3-and/or 6-months comparing to usual practices (TAU).
3. Gaming do not cause more adverse effects up to 6 months, especially aggression at 3-and/or 6-months follow-ups comparing to usual practices (TAU).

The effectiveness of the gaming will be assessed using a controlled clinical trial with a pragmatic, multi-center, two-arms parallel-group design. Feasibility will also be assessed.

Conditions

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Psychotic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A controlled clinical trial with a pragmatic, multi-center, two-arms parallel-group design.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Statisticians will be masked. Gaming facilitators, research assistant who collect the data or staff working in the study sites are not masked.

Study Groups

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Gaming

Gaming intervention with entertainment video games will be run in small groups (6-10 players) closely monitored by trained gaming facilitators. Pre-scheduled gaming sessions, about 60 minutes each, will be run twice a week over 10 weeks (totally 20 hours).

Group Type EXPERIMENTAL

Entertainment gaming

Intervention Type BEHAVIORAL

If needed, gaming schedule will be tailored based on the participants' individual needs (working, studying, family issues) as long as the total gaming hours will be achieved. Participants are encouraged not to play video games during the study period. Participants' gaming interventions will be monitored carefully and recorded after each gaming session in specific gaming diary.

Treatment as usual (TAU)

Participants will join usual practices as planned in community services. No specific activities will be organized to them by the research team.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Entertainment gaming

If needed, gaming schedule will be tailored based on the participants' individual needs (working, studying, family issues) as long as the total gaming hours will be achieved. Participants are encouraged not to play video games during the study period. Participants' gaming interventions will be monitored carefully and recorded after each gaming session in specific gaming diary.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Finnish speaking
* A formal diagnosis of psychotic disorders (F20-F29, ICD-10; to be identified in medical records or other reliable sources by staff)
* Age between 18 and 60 years old
* Ability to participate in the study based on their own free will
* Ability to provide written informed consent

Exclusion Criteria

* Clinical diagnostic criteria for a current major depressive, manic or hypomanic episode or mental retardation (ICD-10)
* Severe visual impairment
* Signs or diagnosis of gaming addiction
* Lack of ability to decide one's own participation (under guardianship)
* Substance abuse (other than nicotine dependence)
* Head injury, hemiplegia, or other neurological disorder
* Electroconvulsive therapy (ECT) in the past six months
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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City of Helsinki

OTHER

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Maritta Välimäki

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maritta Välimäki, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Turku

Locations

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City of Helsinki

Helsinki, South Finland, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Maritta Välimäki, PhD

Role: CONTACT

+358405599235

Facility Contacts

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Kati Sinivuori

Role: primary

+358-40 6375227

References

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Choi WT, Yu DK, Wong T, Lantta T, Yang M, Valimaki M. Habits and Attitudes of Video Gaming and Information Technology Use in People with Schizophrenia: Cross-Sectional Survey. J Med Internet Res. 2020 Jul 22;22(7):e14865. doi: 10.2196/14865.

Reference Type BACKGROUND
PMID: 32459646 (View on PubMed)

Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.

Reference Type BACKGROUND
PMID: 33539561 (View on PubMed)

Athanasopoulou C, Valimaki M, Koutra K, Lottyniemi E, Bertsias A, Basta M, Vgontzas AN, Lionis C. Internet use, eHealth literacy and attitudes toward computer/internet among people with schizophrenia spectrum disorders: a cross-sectional study in two distant European regions. BMC Med Inform Decis Mak. 2017 Sep 20;17(1):136. doi: 10.1186/s12911-017-0531-4.

Reference Type BACKGROUND
PMID: 28931385 (View on PubMed)

Valimaki M, Kuosmanen L, Hatonen H, Koivunen M, Pitkanen A, Athanasopoulou C, Anttila M. Connectivity to computers and the Internet among patients with schizophrenia spectrum disorders: a cross-sectional study. Neuropsychiatr Dis Treat. 2017 Apr 27;13:1201-1209. doi: 10.2147/NDT.S130818. eCollection 2017.

Reference Type BACKGROUND
PMID: 28490882 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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UNITurku

Identifier Type: -

Identifier Source: org_study_id

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