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

October 12, 2023 updated by: Paola Pedrelli, Hedonia Ltd

A Treatment for Depression Via App-Based FTP (Game4Mood Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Individuals with Major Depressive Disorder who have access to an FTP-based mobile phone application for eight weeks.
Other: FTP-based therapeutic mobile-app
Participants are expected to play games within the mobile app and complete the available daily levels of 4 out of 5 games on at least 4 days per week for 8 weeks.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression scores on the Montgomery-Åsberg Depression Rating Scale (MADRS clinical assessment)
Time Frame: Baseline, week 4, and week 8
Validated clinician-based assessment; a 10-item scale with total scores between 0 and 60 where higher scores indicate greater depression severity
Baseline, week 4, and week 8
Change in breadth of thought and ruminations scores on the Ruminative Response Scale (RRS)
Time Frame: From baseline to week 8, one time per week
Validated self-report questionnaire; a 22-item scale with total scores between 22 and 88 where higher scores indicate higher degrees of ruminative symptoms
From baseline to week 8, one time per week
Change in Anhedonia level on the Snaith-Hamilton Pleasure Scale (SHAPS)
Time Frame: From baseline to week 8, one time per week
Validated self-report questionnaire; a 14-item scale with total scores between 0 and 14 where higher scores indicate higher levels of anhedonia
From baseline to week 8, one time per week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression symptoms severity on the Patient Health Questionnaire (PHQ-9)
Time Frame: From baseline to week 8, one time per week
Validated self-report questionnaire; a 9-item scale with total scores between 0 and 27 where higher scores indicate greater symptoms severity
From baseline to week 8, one time per week
Change in depression symptoms severity on the Symptoms of Depression Questionnaire (SDQ)
Time Frame: Baseline, week 4, and week 8
Validated self-reported questionnaire assessing symptoms in the anxiety-depression spectrum; a 44-item scale with total scores between 44 and 264 where higher scores indicate greater symptoms severity
Baseline, week 4, and week 8
Change in anxiety measure on the General Anxiety Disorder-7 (GAD-7)
Time Frame: From baseline to week 8, one time per week
Validated self-report questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater anxiety levels
From baseline to week 8, one time per week
Change in quality of life score as assessed by the World Health Organization Quality of Life scale - short version (WHO-QOL BREF)
Time Frame: Baseline, week 4, and week 8
Validated self-report questionnaire; a 26-item scale with total scores between 0 and 100 where higher scores indicate the greater perceived quality of life
Baseline, week 4, and week 8
Change in mood scores on the Positive and Negative Affect Schedule (PANAS)
Time Frame: From baseline to week 8, one time per week
Validated self-report questionnaire; two 10-item scales with total scores between 10 and 50 for each set of items. On the negative affect scale, higher scores indicate greater severity; on the positive affect scale, higher scores indicate greater positive affect
From baseline to week 8, one time per week
Change in performance in the game
Time Frame: continuous use during the 8-week study
Evaluate change in success rate, when improvement in performance measured by answering the level correctly
continuous use during the 8-week study
Change in engagement levels
Time Frame: continuous use during the 8-week study
Measured by change in the average play time (minutes) over the course of 8 weeks
continuous use during the 8-week study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hedonia Ltd

Investigators

  • Principal Investigator: Paola Pedrelli, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P002100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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