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The Impact of Gaming on Functioning Among People With Schizophrenia (GAME-A)

U

University of Turku

Status

Enrolling

Conditions

Psychotic Disorder

Treatments

Behavioral: Entertainment gaming

Study type

Interventional

Funder types

Other

Identifiers

NCT05707689
UNITurku

Details and patient eligibility

About

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.

Full description

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.

Enrollment

356 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

356 participants in 2 patient groups

Gaming
Experimental group
Description:
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).
Treatment:
Behavioral: Entertainment gaming
Treatment as usual (TAU)
No Intervention group
Description:
Participants will join usual practices as planned in community services. No specific activities will be organized to them by the research team.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Maritta Välimäki, PhD

Data sourced from clinicaltrials.gov

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