A Treatment for Depression Via a Gamified Mobile Phone Application Based on a New Cognitive Model

The study is a randomized controlled treatment study comparing changes in depressive symptoms over 8 weeks between individuals with Major Depressive Disorder (MDD) who have access to an FTP-based mobile phone application and a control group not engaging with the app. FTP, the process of Facilitating Thought Progression, trains the brain's cognitive thought process to expand, accelerate, and be more creative, to alleviate depressive symptoms.

Inclusion Criteria:Consenting Adults, ages 20-50Able to read, understand and provide written informed consent in EnglishParticipants who are the sole users of an iPhone or an Android smartphone, and agree to download and use the digital mobile phone application as required by the protocolParticipants who are comfortable using applications and games on their smartphonesParticipants with a current primary diagnosis of MDD or mild depression. MADRS≥15 and <35Participants who are taking any medications which are FDA approved or used off-label for mood or anxiety should be on a stable dosage for the past 6 weeks and have no plan to change dosage during the 8 weeks they will be in the studyParticipants who are receiving therapy should have been with the same therapist for the previous 60 days and have no plan to change therapy protocol during the 8 weeks of the studyExclusion Criteria:Participants who have plans to change their medications which are FDA approved or used off-label for mood or anxiety or their therapy protocol during the 8 weeks of the studyParticipants who have made any changes to their therapy protocol, including starting therapy, stopping therapy, or changing providers within the past 60 daysParticipants who have made any changes to medications which are FDA-approved or used off-label for mood or anxiety in the last 6 weeksParticipants who have used a computer, web, or smartphone software-based application for mental health or depression in the last 6 weeksBeing at imminent risk for Suicidal behavior (via MINI)Note: Other protocol-defined exclusion criteria applied.