Maritta Välimäki1,2,3, Min Yang4,5, Yuen Ting Joyce Lam6, Tella Lantta7, Matias Palva8, Satu Palva8, Benjamin Yee9, Siu Hung Yip10, Kin-Sun Dan Yu11, Hing Chiu Charles Chang12, Po Yee Ivy Cheng13, Daniel Bressington14. 1. Xiangya Nursing School, Central South University, 172 Tongzipo Road, Changsha, 410013, Hunan, China. maritta.vaelimaeki@csu.edu.cn. 2. School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, Hong Kong SAR. maritta.vaelimaeki@csu.edu.cn. 3. Department of Nursing Science, Faculty of Medicine, University of Turku, 20014, Turku, Finland. maritta.vaelimaeki@csu.edu.cn. 4. West China School of Public Health, Sichuan University, Chengdu, China. 5. Faculty of Health, Art and Design, Swinburne University of Technology, Melbourne, Victoria, 3122, Australia. 6. School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, Hong Kong SAR. 7. Department of Nursing Science, Faculty of Medicine, University of Turku, 20014, Turku, Finland. 8. Neuroscience Center, University of Helsinki, Helsinki, Finland. 9. Department of Rehabilitation Sciences, Hung Hom, Kowloon, The Hong Kong Polytechnic University, Hong Kong, Hong Kong SAR. 10. Department of Psychiatry, Kowloon Hospital, Hong Kong, Hong Kong SAR. 11. The Mental Health Association of Hong Kong, 2 Kung Lok Road, Hong Kong, Hong Kong SAR. 12. Department of Diagnostic Radiology, The Hong Kong Jockey Club for Interdisciplinary Research, The University of Hong Kong, 5 Sassoon Road, Hong Kong, Hong Kong SAR. 13. Department of Psychiatry, Community Psychiatry, Pamela Youde Nethersole Eastern Hospital, Hong Kong, Hong Kong SAR. 14. College of Nursing and Midwifery, Charles Darwin University, Darwin, Australia.
Abstract
BACKGROUND:Video gaming is a promising intervention for cognitive and social impairment in patients with schizophrenia. A number of gaming interventions have been evaluated in small-scale studies with various patient groups, but studies on patients with schizophrenia remain scarce and rarely include the evaluation of both clinical and neurocognitive outcomes. In this study, we will test the effectiveness of two interventions with gaming elements to improve cognitive and clinical outcomes among persons with schizophrenia. METHODS: The participants will be recruited from different outpatient units (e.g., outpatient psychiatric units, day hospitals, residential care homes). The controlled clinical trial will follow a three-arm parallel-group design: 1) cognitive training (experimental group, CogniFit), 2) entertainment gaming (active control group, SIMS 4), and 3) treatment as usual. The primary outcomes are working memory function at 3-month and 6-month follow-ups. The secondary outcomes are patients' other cognitive and social functioning, the ability to experience pleasure, self-efficacy, and negative symptoms at 3-month and 6-month follow-ups. We will also test the effectiveness of gaming interventions on neurocognitive outcomes (EEG and 3 T MRI plus rs-fMRI) at a 3-month follow-up as an additional secondary outcome. Data will be collected in outpatient psychiatric services in Hong Kong. Participants will have a formal diagnosis of schizophrenia and be between 18 and 60 years old. We aim to have a total of 234 participants, randomly allocated to the three arms. A sub-sample of patients (N = 150) will be recruited to undergo an EEG. For neuroimaging assessment, patients will be randomly allocated to a subset of patients (N=126). We will estimate the efficacy of the interventions on the primary and secondary outcomes based on the intention-to-treat principle. Behavioural and EEG data will be analysed separately. DISCUSSION: The study will characterise benefits of gaming on patients' health and well-being, and contribute towards the development of new treatment approaches for patients with schizophrenia. TRIAL REGISTRATION: ClinicalTrials.gov NCT03133143 . Registered on April 28, 2017.
RCT Entities:
ract_title">BACKGROUND: Video gaming is a promising intervention for <span class="Disease">cognitive and social impairment in patients with schizophrenia. A number of gaming interventions have been evaluated in small-scale studies with various patient groups, but studies on patients with schizophrenia remain scarce and rarely include the evaluation of both clinical and neurocognitive outcomes. In this study, we will test the effectiveness of two interventions with gaming elements to improve cognitive and clinical outcomes among persons with schizophrenia. METHODS: The participants will be recruited from different outpatient units (e.g., outpatientpsychiatric units, day hospitals, residential care homes). The controlled clinical trial will follow a three-arm parallel-group design: 1) cognitive training (experimental group, CogniFit), 2) entertainment gaming (active control group, SIMS 4), and 3) treatment as usual. The primary outcomes are working memory function at 3-month and 6-month follow-ups. The secondary outcomes are patients' other cognitive and social functioning, the ability to experience pleasure, self-efficacy, and negative symptoms at 3-month and 6-month follow-ups. We will also test the effectiveness of gaming interventions on neurocognitive outcomes (EEG and 3 T MRI plus rs-fMRI) at a 3-month follow-up as an additional secondary outcome. Data will be collected in outpatientpsychiatric services in Hong Kong. Participants will have a formal diagnosis of schizophrenia and be between 18 and 60 years old. We aim to have a total of 234 participants, randomly allocated to the three arms. A sub-sample of patients (N = 150) will be recruited to undergo an EEG. For neuroimaging assessment, patients will be randomly allocated to a subset of patients (N=126). We will estimate the efficacy of the interventions on the primary and secondary outcomes based on the intention-to-treat principle. Behavioural and EEG data will be analysed separately. DISCUSSION: The study will characterise benefits of gaming on patients' health and well-being, and contribute towards the development of new treatment approaches for patients with schizophrenia. TRIAL REGISTRATION: ClinicalTrials.gov NCT03133143 . Registered on April 28, 2017.
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