The Effects of Videogames on Depression Symptoms and Brain Dynamics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aalto University
- Enrollment
- 1,001
- Locations
- 11
- Primary Endpoint
- PHQ-9 total change from baseline to posttreatment: experimental group vs. treatment as usual group
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The research design is randomized and double-blinded. Subject randomization in study arms as well as treatment is automatized.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
TAU
Treatment-as-usual.
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.
Intervention: MEL-T01 (Device)
MEL-S01
MEL-S01 is an active comparator similar to MEL-T01 but without personalized cognitive training elements.
Intervention: MEL-S01 (Device)
Outcomes
Primary Outcomes
PHQ-9 total change from baseline to posttreatment: experimental group vs. treatment as usual group
Time Frame: Day 0 to Day 84
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.
PHQ-9 total change from baseline to posttreatment: experimental group vs. active comparator group
Time Frame: Day 0 to Day 84
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.
PHQ-9 total change from baseline to posttreatment: active comparator group vs. treatment as usual group
Time Frame: Day 0 to Day 84
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.
Secondary Outcomes
- 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)
- PVSS total change from baseline to posttreatment(Day 0 to Day 84)
- WHO-5 total change from baseline to posttreatment(Day 0 to Day 84)
- Correlation between PHQ-9 total change and playing time in group MEL-S01(Day 0 to Day 84)
- Correlation between PHQ-9 total change and playing time in group MEL-T01(Day 0 to Day 84)
- Correlation between PHQ-9 total change and IEQ in group MEL-T01(Day 0 to Day 84)
- Correlation between PHQ-9 total change and IEQ in group MEL-S01(Day 0 to Day 84)
- SDS total change from baseline to posttreatment(Day 0 to Day 84)