Clinical trial NCT05685758: A Treatment for Depression Via a Gamified Mobile Phone Application Based on a New Cognitive Model
Official title: A Treatment for Depression Via App-Based FTP (Game4Mood Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Disorder
Clinical Depression
Major Depressive Disorder
Keywords: Depression
Ruminations
Mobile-app
Therapeutic Game
FTP
Digital Health
Mood Disorders
Lead sponsor: Hedonia Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 117
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in depression scores on the Montgomery-Åsberg Depression Rating Scale (MADRS clinical assessment)
timeFrame: Baseline, week 4, and week 8
measure: Change in breadth of thought and ruminations scores on the Ruminative Response Scale (RRS)
timeFrame: From baseline to week 8, one time per week
measure: Change in Anhedonia level on the Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: From baseline to week 8, one time per week
Secondary outcomes:
measure: Change in depression symptoms severity on the Patient Health Questionnaire (PHQ-9)
timeFrame: From baseline to week 8, one time per week
measure: Change in depression symptoms severity on the Symptoms of Depression Questionnaire (SDQ)
timeFrame: Baseline, week 4, and week 8
measure: Change in anxiety measure on the General Anxiety Disorder-7 (GAD-7)
timeFrame: From baseline to week 8, one time per week
measure: Change in quality of life score as assessed by the World Health Organization Quality of Life scale - short version (WHO-QOL BREF)
timeFrame: Baseline, week 4, and week 8
measure: Change in mood scores on the Positive and Negative Affect Schedule (PANAS)
timeFrame: From baseline to week 8, one time per week
measure: Change in performance in the game
timeFrame: continuous use during the 8-week study
measure: Change in engagement levels
timeFrame: continuous use during the 8-week study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Paola Pedrelli, PhD
role: PRINCIPAL_INVESTIGATOR
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