NCT05707689

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

January 9, 2023

Last Update Submit

February 15, 2023

Conditions

Psychotic Disorder

Keywords

psychotic disordergamingfunctioning

Outcome Measures

Primary Outcomes (1)

  • Functioning

    The change in functioning will be assessed with the Personal and Social Performance Scale. The instrument includes four domains: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. Difficulty in each area is rated on a single item using a six-point scale (absent, mild, manifest but not marked, marked, severe, or very severe). A global item will be rated by the nurse, ranging from 1 to 100 in ten-point intervals: lower scores indicate poorer functioning.

    Day 0, Month 3, Month 6

Secondary Outcomes (18)

  • Major symptoms of mental health

    Day 0, Month 3, Month 6

  • Depressive symptoms

    Day 0, Month 3, Month 6

  • Self-efficacy

    Day 0, Month 3, Month 6

  • The quality of life

    Day 0, Month 3, Month 6

  • Engagement with the intervention

    Through intervention completion, an average 3 months

  • +13 more secondary outcomes

Other Outcomes (7)

  • Feasibility of the study: Patient refusal

    Through study completion, an average 6 months

  • Feasibility of the intervention

    Month 3

  • Fidelity of the intervention: The total number of gaming sessions

    Through intervention, an average 3 months

  • +4 more other outcomes

Study Arms (2)

Gaming

EXPERIMENTAL

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).

Behavioral: Entertainment gaming

Treatment as usual (TAU)

NO INTERVENTION

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

Interventions

Entertainment gamingBEHAVIORAL

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.

Gaming

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Helsinki

Helsinki, South Finland, Finland

RECRUITING

Related Publications (5)

  • 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.

    PMID: 32459646BACKGROUND

  • 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.

    PMID: 33539561BACKGROUND

  • 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.

    PMID: 28931385BACKGROUND

  • 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.

    PMID: 28490882BACKGROUND

  • Valimaki M, Satamo M, Yang M, Vahlberg T. The impact of gaming on functioning among people with schizophrenia: study protocol for a randomised controlled trial (GAME-A). Trials. 2026 Jan 21. doi: 10.1186/s13063-026-09456-2. Online ahead of print.

    PMID: 41566338DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Maritta Välimäki, PhD

    University of Turku

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maritta Välimäki, PhD

CONTACT

+358405599235mava@utu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Statisticians will be masked. Gaming facilitators, research assistant who collect the data or staff working in the study sites are not masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A controlled clinical trial with a pragmatic, multi-center, two-arms parallel-group design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2023

First Posted

February 1, 2023

Study Start

February 6, 2023

Primary Completion

June 30, 2024

Study Completion

January 30, 2025

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

According to the Ethical Approval, the data will not be shared to other researchers. A meta-data of the study (a general description) will be openly available to researchers.

Locations

FI(1)