Examining the safety and effectiveness of video games that encourage physical activity for young people with depressive symptoms

JRCT ID: jRCT1031240103

Registered date:22/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Depressive symptoms
• Date of first enrollment: 14/05/2024
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Intervention group (Group A): Play the digital deluxe edition of Samba DE Amigo for at least 30 minutes every day for 4 weeks. In addition, records regarding behavior and fatigue will be made once a day. Samba DE Amigo digital deluxe edition is developed and published by SEGA XD Co., Ltd.

Intervention group (Group B): Play the Apple Arcade edition of Samba DE Amigo for at least 30 minutes every day for 4 weeks. In addition, records regarding behavior and fatigue will be made once a day. Samba DE Amigo Apple Arcade edition is developed and provided by SEGA XD Co., Ltd.

Control group: Participants will use the lifestyle recording tool created for this study once a day for 4 weeks. The time required for each use of this tool is approximately 5 minutes."

Outcome(s)

• Primary Outcome: Patient Health Questionnaire (PHQ)-9

Secondary Outcome

Kessler Psychological Distress Scale (K6)
GAMES test
Ten Item Personality Inventory (TIPI-J)
Resilience Scale (RS-14)
PERMA Profiler
Implementation Outcome Scales for Digital Mental Health (iOSDMH) for USERs
Play Time
Frequency of Play

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 30age old
• Gender: Both

Include criteria

Primary registration
(1) Those who are 18 years old or over and 29 years old or under
(2) Those who can continue playing the specified game for at least 30 minutes every day during the exam period
(3) Those who own a compatible device (i.e., Nintendo Switch)
(4) Those who own an iPhone or iPad
(5) Students of the following universities and employees of companies based in Tokyo and Kanagawa
Yokohama City University, Kanagawa University, Kanagawa Prefectural University of Health and Welfare, Yokohama National University, Chuo University, Keio University
Askade Co., Ltd., Garmin Japan Co., Ltd., Kodansha Co., Ltd., Susmed Co., Ltd., Sumitomo Pharma Co., Ltd., Real Virtual Co., Ltd., Benesse Corporation, Murata Manufacturing Co., Ltd., DUMSCO Co., Ltd., PST Co., Ltd., VIE STYLE Co., Ltd. Papageno Co., Ltd., Malus Co., Ltd.
(6) Those who can consent to participate in this research

Secondary registration
(1) Those experiencing depressive symptoms (mild to moderate on both twice measuring PHQ-9: PHQ-9 score = 5-14)"

Exclude criteria

Primary registration
(1) Those who have experience playing the video game which is applied as test equipment
(2) Those who are received ambulatory medical institutions as mental illness patients or have a medical history of mental disorder."
(3) Those with a past history of depression
Secondary registration
(1) Those with 3 points in PHQ-9 question item 9
(2) People who may be addicted to games

Related Information

• Primary Sponsor: Ide Keiko
• Source(s) of Monetary Support: Japan Science and Technology Agency (JST)