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| Name | Class |
|---|---|
| City of Helsinki | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entertainment gaming | Behavioral | 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. |
| 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 |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maritta Välimäki, PhD | Contact | +358405599235 | mava@utu.fi |
| Name | Affiliation | Role |
|---|---|---|
| Maritta Välimäki, PhD | University of Turku | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Helsinki | Recruiting | Helsinki | South Finland | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32459646 | Background | 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. | |
| 33539561 | Background | 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. |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 23, 2022 | Feb 15, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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A controlled clinical trial with a pragmatic, multi-center, two-arms parallel-group design.
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Statisticians will be masked. Gaming facilitators, research assistant who collect the data or staff working in the study sites are not masked.
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| 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 |
| 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 |
| 28931385 | Background | 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. |
| 28490882 | Background | 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. |
| 41566338 | Derived | 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;27(1):135. doi: 10.1186/s13063-026-09456-2. |