The Effects of Videogames on Depression Symptoms and Brain Dynamics

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    800
  • sponsor
    Aalto University
Updated on 4 October 2022
Accepts healthy volunteers

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.

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.

Details
Condition Major Depressive Disorder
Treatment MEL-T01, MEL-S01
Clinical Study IdentifierNCT05426265
SponsorAalto University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Between 18-65 year-old
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 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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