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

Hedonia

Status: Completed

Conditions: Major Depressive Disorder; Clinical Depression; Depression; Depressive Disorder

Treatments: Other: FTP-based therapeutic mobile-app

Study type: Interventional

Funder types: Industry

Identifiers

NCT05685758

2022P002100

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 117 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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117 participants in 2 patient groups

Intervention group

Experimental group

Description:

Individuals with Major Depressive Disorder who have access to an FTP-based mobile phone application for eight weeks.

Treatment:

Other: FTP-based therapeutic mobile-app

Control group

No Intervention group

Description:

Individuals with Major Depressive Disorder who are on an 8-week waitlist (delayed intervention) before being offered to use the app. During the eight weeks, they will be subjected to the same questionnaires and assessments as the intervention arm.