The Effects of Videogames on Depression Symptoms and Brain Dynamics

Last updated: January 30, 2025
Sponsor: Aalto University
Overall Status: Completed

Phase

N/A

Condition

Depression

Depression (Major/severe)

Affective Disorders

Treatment

MEL-T01

MEL-S01

Clinical Study ID

NCT05426265
MelioraRCT
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of the study is to evaluate the effects of a game-based digital-therapeutics (DTx) medical software device on the symptoms of depression in adults with confirmed major depressive disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Between 18-65 year-old

  • Suffering from major depressive disorder

  • Have an ongoing mental health treatment contact to basic healthcare, specialisedhealthcare, 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

Exclusion Criteria:

  • They have threat of self-harm

  • 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

Study Design

Total Participants: 1001
Treatment Group(s): 2
Primary Treatment: MEL-T01
Phase:
Study Start date:
June 28, 2022
Estimated Completion Date:
August 14, 2024

Study Description

The study is a comparator-controlled, randomised, double-blinded intervention study aimed at assessing the effects of the investigational device MEL-T01, "Meliora", on the symptoms of major depressive disorder (MDD). MEL-S01 acts as a comparator. MEL-T01 is a game-based digital-therapeutics (DTx) medical software device developed at Aalto University and is intended to be used as a treatment for MDD together with treatment-as-usual (TAU). MEL-T01 implements personalised cognitive training to alleviate MDD symptoms and improve cognitive performance in MDD subjects.

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.

Connect with a study center

  • Aalto University (TMS)

    Espoo, Uusimaa 02150
    Finland

    Site Not Available

  • Aalto University, Department of Neuroscience and Biomedical Engineering

    Espoo, Uusimaa 02150
    Finland

    Site Not Available

  • Helsinki University Hospital BioMag laboratory

    Helsinki, Uusimaa 00029
    Finland

    Site Not Available

  • Helsinki University Hospital, Psychiatry

    Helsinki, Uusimaa 00014
    Finland

    Site Not Available

  • University of Helsinki Neuroscience Center (MEG, MRI)

    Helsinki, Uusimaa
    Finland

    Site Not Available

  • Turku University Hospital

    Turku, Varsinais-Suomi 20521
    Finland

    Site Not Available

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