The Effects of Videogames on Depression Symptoms and Brain Dynamics

Aalto University

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Device: MEL-S01; Device: MEL-T01

Study type: Interventional

Funder types: Other

Identifiers

NCT05426265

MelioraRCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,001 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,001 participants in 3 patient groups

MEL-T01

Experimental group

Description:

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.

Treatment:

Device: MEL-T01

MEL-S01

Active Comparator group

Description:

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

Treatment:

Device: MEL-S01

TAU

No Intervention group

Description:

Treatment-as-usual.