Clinical trial NCT05707689: The Impact of Gaming on Functioning Among People With Schizophrenia
Official title: The Impact of Gaming on Functioning Among People With Schizophrenia: a Randomised Controlled Trial (GAME-A)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychotic Disorder
Keywords: psychotic disorder
gaming
functioning
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: City of Helsinki
First posted: 2023-02-01
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A controlled clinical trial with a pragmatic, multi-center, two-arms parallel-group design.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functioning
timeFrame: Day 0, Month 3, Month 6
Secondary outcomes:
measure: Major symptoms of mental health
timeFrame: Day 0, Month 3, Month 6
measure: Depressive symptoms
timeFrame: Day 0, Month 3, Month 6
measure: Self-efficacy
timeFrame: Day 0, Month 3, Month 6
measure: The quality of life
timeFrame: Day 0, Month 3, Month 6
measure: Engagement with the intervention
timeFrame: Through intervention completion, an average 3 months
measure: Engagement with the study (%)
timeFrame: Through study completion, an average 6 months
measure: Adverse effect: Relapse, a dosage increased
timeFrame: Through study completion, an average 6 months
measure: Adverse effect: Relapse, additional medicines prescribed
timeFrame: Through study completion, an average 6 months
measure: Adverse effect: Symptoms
timeFrame: Through study completion, an average 6 months
measure: Adverse effect: Admission into psychiatric hospital (yes/no)
timeFrame: Through study completion, an average 6 months
measure: Adverse effect: The number of hospitalisations
timeFrame: Through study completion, an average 6 months
measure: Adverse effect: The number of hospital days
timeFrame: Through study completion, an average 6 months
measure: Adverse effect: Violent incidents
timeFrame: Through study completion, an average 6 months
measure: Adverse effect: The number of violent incidents
timeFrame: Through study completion, an average 6 months
measure: Adverse effect: Self-harming
timeFrame: Through study completion, an average 6 months
measure: Adverse effect: The number of self-harm incidents
timeFrame: Through study completion, an average 6 months
measure: Adverse effect: Aggression
timeFrame: Day 0, Month 3, Month 6
measure: Adverse effect: Death
timeFrame: Through study completion, an average 6 months
Other outcomes:
measure: Feasibility of the study: Patient refusal
timeFrame: Through study completion, an average 6 months
measure: Feasibility of the intervention
timeFrame: Month 3
measure: Fidelity of the intervention: The total number of gaming sessions
timeFrame: Through intervention, an average 3 months
measure: Fidelity of the intervention: The total intervention time
timeFrame: Through intervention, an average 3 months
measure: Acceptability of the intervention
timeFrame: Month 3
measure: Appropriateness of the intervention
timeFrame: Month 3
measure: Implementation process of the novel intervention (qualitative interviews)
timeFrame: Through the study, an average 6 months
Locations:
city: Helsinki
country: Finland
facility: City of Helsinki
state: South Finland
Study officials:
affiliation: University of Turku
name: Maritta Välimäki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.