The Effects of Videogames on Depression Symptoms and Brain Dynamics

NCT05426265 | Completed Results

• 1 other identifier: MelioraRCT
• Study Type: interventional
• Target: 1,001
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Depression; Digital therapeutics; Digital mental health intervention

Outcome Measures

Primary Outcomes (3)

• PHQ-9 Total Change From Baseline to Posttreatment: Experimental Group vs. Treatment as Usual Group

  The patient health questionnaire (PHQ-9, Kroenke et al., 2001) is a self-report measure of major depressive disorder. The PHQ-9 scores each of the nine DSM-IV criteria for MDD from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score of depression. The higher the total score the more severe the depression. The change in the PHQ-9 total score between before the 12 week intervention and after the intervention is measured. The change score of MEL-T01 group is compared with the change score of the treatment-as-usual (TAU) group.

  Day 0 to Day 84

• PHQ-9 Total Change From Baseline to Posttreatment: Active Comparator Group vs. Treatment as Usual Group

  The patient health questionnaire (PHQ-9, Kroenke et al., 2001) is a self-report measure of major depressive disorder. The PHQ-9 scores each of the nine DSM-IV criteria for MDD from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score of depression. The higher the total score the more severe the depression. The change in the PHQ-9 total score between before the 12 week intervention and after the intervention is measured. The change score of MEL-S01 group is compared with the change score of the treatment-as-usual (TAU) group.

  Day 0 to Day 84

• PHQ-9 Total Change From Baseline to Posttreatment: Experimental Group vs. Active Comparator Group

  The patient health questionnaire (PHQ-9, Kroenke et al., 2001) is a self-report measure of major depressive disorder. The PHQ-9 scores each of the nine DSM-IV criteria for MDD from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score of depression. The higher the total score the more severe the depression. The change in the PHQ-9 total score between before the 12 week intervention and after the intervention is measured. The change score of MEL-T01 group is compared with the change score in the MEL-S01 group.

  Day 0 to Day 84

Secondary Outcomes (10)

• QIDS Total Change From Baseline to Posttreatment

  Day 0 to Day 84

• RRS (Short Version) Total Change From Baseline to Posttreatment

  Day 0 to Day 84

• GAD-7 Total Change From Baseline to Posttreatment

  Day 0 to Day 84

• SDS Total Change From Baseline to Posttreatment

  Day 0 to Day 84

• PVSS Total Change From Baseline to Posttreatment

  Day 0 to Day 84

Other Outcomes (1)

• GAS Total Change From Baseline to Posttreatment

  Day 0 to Day 84

Study Arms (3)

MEL-T01

EXPERIMENTAL

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.

Device: MEL-T01

MEL-S01

ACTIVE COMPARATOR

MEL-S01 is an active comparator similar to MEL-T01 but without personalized cognitive training elements.

Device: MEL-S01

TAU

NO INTERVENTION

Treatment-as-usual.

Interventions

MEL-T01 DEVICE

A 12 week intervention with MEL-T01.

Also known as: Meliora

MEL-T01

MEL-S01 DEVICE

A 12 week intervention with MEL-S01.

MEL-S01

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalto University: lead
• Business Finland: collaborator
• Helsinki University Central Hospital: collaborator
• Turku University Hospital: collaborator

Study Sites (6)

Turku University Hospital

Turku, Southwest Finland, 20521, Finland

Location

Aalto University (TMS)

Espoo, Uusimaa, 02150, Finland

Location

Aalto University, Department of Neuroscience and Biomedical Engineering

Espoo, Uusimaa, 02150, Finland

Location

Helsinki University Hospital, Psychiatry

Helsinki, Uusimaa, 00014, Finland

Location

Helsinki University Hospital BioMag laboratory

Helsinki, Uusimaa, 00029, Finland

Location

University of Helsinki Neuroscience Center (MEG, MRI)

Helsinki, Uusimaa, Finland

Location

Related Publications (1)

• 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.

  PMID: 40165237 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Not reaching the intended number (n = 133) of completer subjects in MEL-T01 (n = 99) and MEL-S01 (n = 96) arms.

Results Point of Contact

• Title: Prof. J. Matias Palva
• Organization: Aalto University

matias.palva@aalto.fi

+358401547779

Study Officials

• Hanna Renvall, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research design is randomized and double-blinded. Subject randomization in study arms as well as treatment is automatized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The effectiveness of MEL-T01 and comparator MEL-S01 are studied. Their effectiveness is compared to a treatment-as-usual (TAU) group who also receive the intervention after a 12 week waiting period.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 21, 2022
• Study Start: June 28, 2022
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (6)