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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,001
Turku University Hospital
Turku, Southwest Finland, Finland
Aalto University (TMS)
Espoo, Uusimaa, Finland
Aalto University, Department of Neuroscience and Biomedical Engineering
Espoo, Uusimaa, Finland
Helsinki University Hospital, Psychiatry
Helsinki, Uusimaa, Finland
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 to Day 84
QIDS total change from baseline to posttreatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Helsinki University Hospital BioMag laboratory
Helsinki, Uusimaa, Finland
University of Helsinki Neuroscience Center (MEG, MRI)
Helsinki, Uusimaa, Finland
The quick inventory of depressive symptomatology (QIDS-SR16) is a self-report measure comprising of 16 questions on a scale of 0-3 which assess the severity of depressive symptoms. The inventory provides a total score between 0 and 48: the higher the total score the more severe the depression. For each of the three study arms, the change in total QIDS-SR16 scores between before the intervention and after the 12 week intervention is measured. Then, the average change scores in each of the three groups are compared with each other.
Time frame: Day 0 to Day 84
RRS (short version) total change from baseline to posttreatment
Ruminative Response Scale (RRS), short version, is an eight item self-report questionnaire that uses a four point Likert-scale. This leads to a total score between 8 and 64 where higher values indicate higher depressive brooding. For each of the three study arms, the change in total RRS scores between before the intervention compared and after the 12 week intervention are measured. Then, the average change scores in each of the three groups are compared with each other.
Time frame: Day 0 to Day 84
GAD-7 total change from baseline to posttreatment
The general anxiety disorder scale (GAD-7) is a seven-item self-report questionnaire that uses a 4-point scale (between 0 and 3) to evaluate the degree of anxiety symptoms. The questionnaire provides a total between 0 and 21: the higher the total score, the more severe the anxiety. For each of the three study arms, the change in total GAD-7 scores between before the intervention and after the 12 week intervention is measured. Then, the average change scores in each of the three groups are compared with each other.
Time frame: Day 0 to Day 84
SDS total change from baseline to posttreatment
The Sheehan disability scale (SDS) is a self-administered three item questionnaire using a 11-point scale (between 0 and 10). The scale is used to measure functional impairment. The scale provides a total score between 0 and 30: the higher the score, the higher the functional impairment. In addition, the scale measures "the number of days lost to symptoms" and "the number of days unproductive due to the symptoms". For each of the three study arms, the change in total SDS scores between before the intervention and after the 12 week intervention is measured. Then, the average change scores in each of the three groups are compared with each other.
Time frame: Day 0 to Day 84
PVSS total change from baseline to posttreatment
The positive valence systems scale (PVSS) is a 21-item self-report questionnaire using a scale from 1 to 9. This leads to a total score between 21 and 189 where a lower total score indicates higher anhedonia. For each of the three study arms, the change in total PVSS scores between before the intervention and after the 12 week intervention is measured. Then, the average change scores in each of the three groups are compared with each other.
Time frame: Day 0 to Day 84
WHO-5 total change from baseline to posttreatment
The well-being index (WHO-5) is a five item self-report questionnaire using a scale from 0 to 5. This leads to a total score is between 0 and 25: higher scores indicate higher subjective well-being. For each of the three study arms, the change in total WHO-5 scores between before the intervention and after the 12 week intervention is measured. Then, the average change scores in each of the three groups are compared with each other.
Time frame: Day 0 to Day 84
Correlation between PHQ-9 total change and playing time in group MEL-T01
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. For the treatment MEL-T01 group, the change scores in the total PHQ-9 score between before the intervention and after the 12 week intervention is measured. Then, the correlation between the change score and the minutes played during the intervention is calculated. This leads to a correlation score that evaluates whether a higher symptom change is associated with higher playing time.
Time frame: Day 0 to Day 84
Correlation between PHQ-9 total change and playing time in group MEL-S01
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. For the active comparator MEL-S01 group, the change scores in the total PHQ-9 score between before the intervention and after the 12 week intervention is measured. Then, the correlation between the change score and the minutes played during the intervention is calculated. This leads to a correlation score that evaluates whether a higher symptom change is associated with higher playing time.
Time frame: Day 0 to Day 84
Correlation between PHQ-9 total change and IEQ in group MEL-T01
The immersive experiences questionnaire (IEQ, Jennett et al., 2008) is a self-report questionnaire that measures the subjective experience of being immersed while playing a video game. It has 31 questions on a scale of 1-7. This creates a total score between 31 and 217: the higher totals indicate higher immersion. In addition, there is one question - "How immersed did you feel?" - on a scale of 1-10. For the treatment MEL-T01 group, we measure the correlation between 1) the change in the total PHQ-9 score between before the intervention and after the 12 week intervention and 2) the total IEQ score (excluding the one additional questionnaire) as measured after the 12 week intervention. This leads to a correlation score that evaluates whether a higher symptom change is associated with higher immersion in the game.
Time frame: Day 0 to Day 84
Correlation between PHQ-9 total change and IEQ in group MEL-S01
The immersive experiences questionnaire (IEQ, Jennett et al., 2008) is a self-report questionnaire that measures the subjective experience of being immersed while playing a video game. It has 31 questions on a scale of 1-7. This creates a total score between 31 and 217: the higher totals indicate higher immersion. In addition, there is one question - "How immersed did you feel?" - on a scale of 1-10. For the treatment MEL-S01 group, we measure the correlation between 1) the change in the total PHQ-9 score between before the intervention and after the 12 week intervention and 2) the total IEQ score (excluding the one additional questionnaire) as measured after the 12 week intervention. This leads to a correlation score that evaluates whether a higher symptom change is associated with higher immersion in the game.
Time frame: Day 0 to Day 84