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: 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
356
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.
City of Helsinki
Helsinki, South Finland, Finland
RECRUITINGFunctioning
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.
Time frame: Day 0, Month 3, Month 6
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0, Month 3, Month 6
The quality of life
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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.
Time frame: 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
Time frame: Through intervention completion, an average 3 months
Engagement with the study (%)
Number of participants who have dropped out from the study (yes/no, n/%)
Time frame: 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/%)
Time frame: 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/%)
Time frame: 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/%)
Time frame: 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/%)
Time frame: Through study completion, an average 6 months
Adverse effect: The number of hospitalisations
The total number of admissions in psychiatric hospital (N)
Time frame: Through study completion, an average 6 months
Adverse effect: The number of hospital days
Total number of hospital days (N)
Time frame: 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/%)
Time frame: 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)
Time frame: 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/%)
Time frame: 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)
Time frame: 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.
Time frame: Day 0, Month 3, Month 6
Adverse effect: Death
Death
Time frame: Through study completion, an average 6 months