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

The Impact of Gaming on Functioning Among People With Schizophrenia: a Randomised Controlled Trial (GAME-A)

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.

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorder
• Intervention / Treatment: Behavioral: Entertainment gaming

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.

• Study Type: Interventional
• Enrollment (Anticipated): 356
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • South Finland
    • Helsinki, South Finland, Finland
      • Recruiting
      • City of Helsinki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major symptoms of mental health	The symptoms of mental health will be assessed by the Behavior and Symptom Identification Scale®, which focuses on psychopathology and functioning, The instrument is a brief, patient self-reported measure with 24 items, structured based on six sub-scales (Depression and Functioning, Relationships, Self-Harm, Emotional Liability, Psychosis, Substance Abuse). Mean scores for sub-scales and the total score are calculated: the lower the score, the less frequent symptoms/difficulty.	Day 0, Month 3, Month 6
Depressive symptoms	The severity of depression will be assessed with the Patient Health Questionnaire-9. The instrument includes nine items. The total score of this self-administered questionnaire is calculated. The range of the score vary between 0 and 27: the higher the score, the severe the depression.	Day 0, Month 3, Month 6
Self-efficacy	Self-efficacy will be assessed using the General Self-Efficacy Scale ith 10 items. Responses of each items are summed up to create a composite score, which ranges grom 10-40: the higher score represent higher self-efficacy.	Day 0, Month 3, Month 6
The quality of life	The quality of life will be assessed with the Quality of Life Enjoyment and Satisfaction. It is a self-report measure with 15 items. Each question is rated on a 5 point scale from 1 (very poor) to 5 (very good). The first 14 items are summed to form a total score, which can be reported as either the raw score (a maximum 70 points) or as percentage maximum possible, with higher scores indicating greater enjoyment and satisfaction of life. In addition, there is one item that is scored individually from 1 to 5 to describe overall life satisfaction.	Day 0, Month 3, Month 6
Engagement with the intervention	Number of participants who have dropped out from the intervention (yes/no, n/%), experimental group only	Through intervention completion, an average 3 months
Engagement with the study (%)	Number of participants who have dropped out from the study (yes/no, n/%)	Through study completion, an average 6 months
Adverse effect: Relapse, a dosage increased	Number of participants with a dosage increase reported by staff (yes/no, n/%)	Through study completion, an average 6 months
Adverse effect: Relapse, additional medicines prescribed	Number of participants with additional medicines prescription reported by staff (yes/no, n/%)	Through study completion, an average 6 months
Adverse effect: Symptoms	Number of participants with an exacerbation of psychotic symptoms leading to any change in patient management (yes/no, n/%)	Through study completion, an average 6 months
Adverse effect: Admission into psychiatric hospital (yes/no)	Number of participants admitted in psychiatric hospital (yes/no, n/%)	Through study completion, an average 6 months
Adverse effect: The number of hospitalisations	The total number of admissions in psychiatric hospital (N)	Through study completion, an average 6 months
Adverse effect: The number of hospital days	Total number of hospital days (N)	Through study completion, an average 6 months
Adverse effect: Violent incidents	Number of participants with any violent incidents necessitating staff involvement (whether victim or accused, targeting to another person or property (yes/no, n/%)	Through study completion, an average 6 months
Adverse effect: The number of violent incidents	Total number of any violent incidents necessitating staff involvement, whether victim or accused, targeting to another person or property (N)	Through study completion, an average 6 months
Adverse effect: Self-harming	Number of participants with any self-harming behavior (e.g. suicide, an attempt of suicide) (yes/no, n/%)	Through study completion, an average 6 months
Adverse effect: The number of self-harm incidents	Total number of any self-harming behavior (e.g. suicide, an attempt of suicide)	Through study completion, an average 6 months
Adverse effect: Aggression	Buss-Perry Aggression Questionnaire-Short Form will assess patient aggression with 12 items and four subareas (anger, physical aggression, hostility, verbal aggression). Items are rated on a 5-point scale ranging from 1 ("extremely uncharacteristic of me") to 5 ("extremely characteristic of me"). The value of each item are calculated to form a total score: a higher score indicate higher aggressive behavior.	Day 0, Month 3, Month 6
Adverse effect: Death	Death	Through study completion, an average 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the study: Patient refusal	Refusal rate (yes/no, n/%)	Through study completion, an average 6 months
Feasibility of the intervention	Feasibility of the intervention will be assessed using Feasibility of Intervention Measure, FIM. It includes four items. Responders are asked to rate one of five options (1= completely disagree, disagree, neither agree nor disagree, agree, completely agree). The sum score will ranges from 4 to 16: the higher the score, the better feasibility.	Month 3
Fidelity of the intervention: The total number of gaming sessions	The total number of gaming sessions participated out of 20 (N/%)	Through intervention, an average 3 months
Fidelity of the intervention: The total intervention time	Total intervention time in hours out of 20 hours (total hours/20, %)	Through intervention, an average 3 months
Acceptability of the intervention	Acceptability of the intervention will be assessed using the Acceptability of Implementation Measure, AIM. It includes four items. Responders are asked to rate one of five options (1= completely disagree, disagree, neither agree nor disagree, agree, completely agree). The sum score will range from 4 to 16: the higher the score, the better acceptability of the intervention.	Month 3
Appropriateness of the intervention	Appropriateness of the intervention will be assessed with the Implementation Appropriateness Measure, IAM. It includes four items. Responders are asked to rate one of five options (1= completely disagree, disagree, neither agree nor disagree, agree, completely agree). The sum score will ranges from 4 to 16: the higher the score, the more appropriate is the intervention.	Month 3
Implementation process of the novel intervention (qualitative interviews)	An organizational analysis will be conducted (Consolidated Framework for Implementation Research,CFIR); interviews with nursing staff of the study organisation will be conducted using five major domains: 1) Intervention characteristics (intervention source, evidence strength and quality, relative advantage etc.), 2) Outer setting (patient needs and resources, peer pressure, external policies and incentives, etc.), 3) Inner setting (structural characteristics, culture, implementation climate, etc.), 4) Characteristics of the individuals involved (knowledge and beliefs about the intervention, self-efficacy, individual stage of change, etc.), and 5) Process of implementation (planning, engaging, executing, etc.).	Through the study, an average 6 months

Collaborators and Investigators

• Sponsor: University of Turku
• Collaborators: City of Helsinki

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): January 30, 2025

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 21, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: psychotic disorder; functioning; gaming
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: UNITurku

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No