The Effects of Videogames on Depression Symptoms and Brain Dynamics
NCT ID: NCT05426265
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1001 participants
INTERVENTIONAL
2022-06-28
2024-08-14
Brief Summary
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Detailed Description
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Subjects volunteering to participate in this investigation are adults whose MDD is confirmed through MINI interview. They have an on-going mental health treatment contact with a mental health professional. The subjects are randomised into three arms with equal probabilities in blocks of six consecutive subjects. Subjects in the MEL-T01 and MEL-S01 arms are engaged in the intervention for 12 weeks while those in the TAU arm are on a follow-up period during these 12 weeks. After this 12-week period, the subjects in MEL-T01 and MEL-S01 arms enter a 12-week follow-up period and the subjects in TAU arm engage with either the MEL-T01 or MEL-S01 intervention (randomised at T0 with equal probability) for 12 weeks.
The subjects are recommended to play the investigational-device game for a total of 48 hours during the 12 weeks of active intervention with a recommended weekly dose of 4 hours. A minimum of 24 hours is needed for inclusion to hypothesis testing. The subjects are limited to a daily maximum of 1.5 hours of game time.
The subjects' mental health symptoms and well-being are evaluated through online questionnaires five times: before subjects are randomised into one of the three groups (T0), and then 4 (T1), 8 (T2), 12 (T3), and 24 (T4) weeks after the study has begun.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MEL-T01
MEL-T01 is a game-based digital-therapeutics (DTx) medical software device that implements personalised cognitive training to alleviate MDD symptoms and improve cognitive performance in MDD subjects.
MEL-T01
A 12 week intervention with MEL-T01.
MEL-S01
MEL-S01 is an active comparator similar to MEL-T01 but without personalized cognitive training elements.
MEL-S01
A 12 week intervention with MEL-S01.
TAU
Treatment-as-usual.
No interventions assigned to this group
Interventions
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MEL-T01
A 12 week intervention with MEL-T01.
MEL-S01
A 12 week intervention with MEL-S01.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Suffering from major depressive disorder
* Have an ongoing mental health treatment contact to basic healthcare, specialised healthcare, student healthcare or occupational healthcare
* Has sufficient eyesight with or without prescription
* Has a Windows computer with internet connection and mouse
* Has email and phone number
Exclusion Criteria
* They have addiction to digital games
* They have psychotic disorders
* They are pregnant or breastfeeding
* They have impaired ability in decision making
* They are prisoner or forensic subject
* They have neurological disorders such as epilepsy or brain injury
18 Years
65 Years
ALL
Yes
Sponsors
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Business Finland
OTHER
Helsinki University Central Hospital
OTHER
Turku University Hospital
OTHER_GOV
Aalto University
OTHER
Responsible Party
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Principal Investigators
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Hanna Renvall, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
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Turku University Hospital
Turku, Southwest Finland, Finland
Aalto University (TMS)
Espoo, Uusimaa, Finland
Aalto University, Department of Neuroscience and Biomedical Engineering
Espoo, Uusimaa, Finland
Helsinki University Hospital, Psychiatry
Helsinki, Uusimaa, Finland
Helsinki University Hospital BioMag laboratory
Helsinki, Uusimaa, Finland
University of Helsinki Neuroscience Center (MEG, MRI)
Helsinki, Uusimaa, Finland
Countries
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References
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Lukka L, Vesterinen M, Salonen A, Bergman VR, Torkki P, Palva S, Palva JM. User journey method: a case study for improving digital intervention use measurement. BMC Health Serv Res. 2025 Apr 1;25(1):479. doi: 10.1186/s12913-025-12641-9.
Other Identifiers
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MelioraRCT
Identifier Type: -
Identifier Source: org_study_id
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