The Impact of Gaming on Functioning Among People With Schizophrenia

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

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

Conditions
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Psychotic Disorder

Intervention / Treatment
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* Behavioral: Entertainment gaming


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A controlled clinical trial with a pragmatic, multi-center, two-arms parallel-group design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gaming<br>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<br>* 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.<br>|
| No Intervention: Treatment as usual (TAU)<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychotic disorder, gaming, functioning