The Effects of Videogames on Depression Symptoms and Brain Dynamics

Sponsor
Aalto University
Study ID
NCT05426265
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • MEL-T01 — DEVICE
    A 12 week intervention with MEL-T01.
  • MEL-S01 — DEVICE
    A 12 week intervention with MEL-S01.

Study Details

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.

Key Dates

Start date
Jun 28, 2022
Status verified
Apr 2026
Primary completion
Aug 14, 2024
Completion
Aug 14, 2024

Study Design

Enrollment
1,001 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: MEL-S01
    MEL-S01 is an active comparator similar to MEL-T01 but without personalized cognitive training elements.
  • No Intervention: TAU
    Treatment-as-usual.

Primary Outcome Measure

PHQ-9 Total Change From Baseline to Posttreatment: Experimental Group vs. Treatment as Usual Group [ Time Frame: Day 0 to Day 84 ]

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