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

Hedonia Ltd117 enrolled

Overview

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.

This project aims to determine the effectiveness of an FTP-based mobile phone application in the alleviation of clinical symptoms of depression. In an attempt to change thought progression to be broader and more readily expansive, we had translated paradigms meant to expand thinking patterns into engaging mobile games. Our hypothesis is that the FTP-based mobile phone application will be able to decrease depressive clinical symptoms in a significant manner. Participants meeting the inclusion criteria will be asked to play the app and undergo clinical and self-assessment evaluations regularly over the course of 8 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

117

Conditions

Depression Depressive Disorder

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Consenting Adults, ages 20-50 * Able to read, understand and provide written informed consent in English * Participants 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 protocol * Participants who are comfortable using applications and games on their smartphones * Participants with a current primary diagnosis of MDD or mild depression. MADRS≥15 and \<35 * Participants 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 study * Participants 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 study Exclusion 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 study * Participants who have made any changes to their therapy protocol, including starting therapy, stopping therapy, or changing providers within the past 60 days * Participants who have made any changes to medications which are FDA-approved or used off-label for mood or anxiety in the last 6 weeks * Participants who have used a computer, web, or smartphone software-based application for mental health or depression in the last 6 weeks * Being at imminent risk for Suicidal behavior (via MINI) Note: Other protocol-defined exclusion criteria applied.

Outcomes

Primary Outcomes

Change in depression scores on the Montgomery-Åsberg Depression Rating Scale (MADRS clinical assessment)

Validated clinician-based assessment; a 10-item scale with total scores between 0 and 60 where higher scores indicate greater depression severity

Time frame: Baseline, week 4, and week 8

Change in breadth of thought and ruminations scores on the Ruminative Response Scale (RRS)

Validated self-report questionnaire; a 22-item scale with total scores between 22 and 88 where higher scores indicate higher degrees of ruminative symptoms