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Completed

NCT Number: NCT05685758

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Clinical Depression Depressive Disorder Depressive Disorder, Major Digestive System Diseases Feeding and Eating Disorders Gastrointestinal Diseases Major Depressive Disorder Mental Disorders Mood Disorders Rumination Syndrome

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FTP-based therapeutic mobile-app

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Hedonia Ltd

Industry

Registry information

Official study title

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

Acronym: FTP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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