Clinical trial NCT05426265: The Effects of Videogames on Depression Symptoms and Brain Dynamics
Official title: The Effects of Videogames on Depression Symptoms and Brain Dynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Digital therapeutics
Digital mental health intervention
Lead sponsor: Aalto University
Sponsor class: OTHER
Collaborators: name: Business Finland
name: Helsinki University Central Hospital
name: Turku University Hospital
First posted: 2022-06-21
Enrollment: 1001
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: PHQ-9 total change from baseline to posttreatment: experimental group vs. treatment as usual group
timeFrame: Day 0 to Day 84
measure: PHQ-9 total change from baseline to posttreatment: active comparator group vs. treatment as usual group
timeFrame: Day 0 to Day 84
measure: PHQ-9 total change from baseline to posttreatment: experimental group vs. active comparator group
timeFrame: Day 0 to Day 84
Secondary outcomes:
measure: QIDS total change from baseline to posttreatment
timeFrame: Day 0 to Day 84
measure: RRS (short version) total change from baseline to posttreatment
timeFrame: Day 0 to Day 84
measure: GAD-7 total change from baseline to posttreatment
timeFrame: Day 0 to Day 84
measure: SDS total change from baseline to posttreatment
timeFrame: Day 0 to Day 84
measure: PVSS total change from baseline to posttreatment
timeFrame: Day 0 to Day 84
measure: WHO-5 total change from baseline to posttreatment
timeFrame: Day 0 to Day 84
measure: Correlation between PHQ-9 total change and playing time in group MEL-T01
timeFrame: Day 0 to Day 84
measure: Correlation between PHQ-9 total change and playing time in group MEL-S01
timeFrame: Day 0 to Day 84
measure: Correlation between PHQ-9 total change and IEQ in group MEL-T01
timeFrame: Day 0 to Day 84
measure: Correlation between PHQ-9 total change and IEQ in group MEL-S01
timeFrame: Day 0 to Day 84
Other outcomes:
measure: GAS total change from baseline to posttreatment
timeFrame: Day 0 to Day 84
Locations:
city: Espoo
country: Finland
facility: Aalto University (TMS)
state: Uusimaa
city: Espoo
country: Finland
facility: Aalto University, Department of Neuroscience and Biomedical Engineering
state: Uusimaa
city: Helsinki
country: Finland
facility: Helsinki University Hospital, Psychiatry
state: Uusimaa
city: Helsinki
country: Finland
facility: Helsinki University Hospital BioMag laboratory
state: Uusimaa
city: Helsinki
country: Finland
facility: University of Helsinki Neuroscience Center (MEG, MRI)
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
Study officials:
affiliation: Helsinki University Central Hospital
name: Hanna Renvall, PhD
role: PRINCIPAL_INVESTIGATOR
References: