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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depression, Depressive Disorder, Clinical Depression, Major Depressive Disorder

Intervention / Treatment
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* Other: FTP-based therapeutic mobile-app


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One hundred and ten participants will be randomly assigned into one of the groups: the intervention group or the control group, which is a delayed intervention group (waitlist intervention). Intervention group participants will be sent a link to download an FTP-based mobile application and be asked to complete weekly surveys and monthly visits with study clinicians for 8 weeks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Individuals with Major Depressive Disorder who have access to an FTP-based mobile phone application for eight weeks. | Other: FTP-based therapeutic mobile-app<br>* 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.<br>|
| No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | From baseline to week 8, one time per week | 
| Change in Anhedonia level on the Snaith-Hamilton Pleasure Scale (SHAPS) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | Measured by change in the average play time (minutes) over the course of 8 weeks | continuous use during the 8-week study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FTP, Depression, Ruminations, Mobile-app, Therapeutic Game, Digital Health, Mood Disorders