Back to resultsA Treatment for Depression Via a Gamified Mobile Phone Application Based on a New Cognitive Model (FTP)
Primary Purpose
Depression, Depressive Disorder, Clinical Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FTP-based therapeutic mobile-app
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Ruminations, Mobile-app, Therapeutic Game, FTP, Digital Health, Mood Disorders
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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Individuals with Major Depressive Disorder who have access to an FTP-based mobile phone application for eight weeks.
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.
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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
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
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
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
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
Change in performance in the game
Evaluate change in success rate, when improvement in performance measured by answering the level correctly
Change in engagement levels
Measured by change in the average play time (minutes) over the course of 8 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05685758
Brief Title
A Treatment for Depression Via a Gamified Mobile Phone Application Based on a New Cognitive Model
Acronym
FTP
Official Title
A Treatment for Depression Via App-Based FTP (Game4Mood Study)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hedonia Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Clinical Depression, Major Depressive Disorder
Keywords
Depression, Ruminations, Mobile-app, Therapeutic Game, FTP, Digital Health, Mood Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Individuals with Major Depressive Disorder who have access to an FTP-based mobile phone application for eight weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
FTP-based therapeutic mobile-app
Intervention Description
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 Outcome Measure Information:
Title
Change in depression scores on the Montgomery-Åsberg Depression Rating Scale (MADRS clinical assessment)
Description
Validated clinician-based assessment; a 10-item scale with total scores between 0 and 60 where higher scores indicate greater depression severity
Time Frame
Baseline, week 4, and week 8
Title
Change in breadth of thought and ruminations scores on the Ruminative Response Scale (RRS)
Description
Validated self-report questionnaire; a 22-item scale with total scores between 22 and 88 where higher scores indicate higher degrees of ruminative symptoms
Time Frame
From baseline to week 8, one time per week
Title
Change in Anhedonia level on the Snaith-Hamilton Pleasure Scale (SHAPS)
Description
Validated self-report questionnaire; a 14-item scale with total scores between 0 and 14 where higher scores indicate higher levels of anhedonia
Time Frame
From baseline to week 8, one time per week
Secondary Outcome Measure Information:
Title
Change in depression symptoms severity on the Patient Health Questionnaire (PHQ-9)
Description
Validated self-report questionnaire; a 9-item scale with total scores between 0 and 27 where higher scores indicate greater symptoms severity
Time Frame
From baseline to week 8, one time per week
Title
Change in depression symptoms severity on the Symptoms of Depression Questionnaire (SDQ)
Description
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
Time Frame
Baseline, week 4, and week 8
Title
Change in anxiety measure on the General Anxiety Disorder-7 (GAD-7)
Description
Validated self-report questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater anxiety levels
Time Frame
From baseline to week 8, one time per week
Title
Change in quality of life score as assessed by the World Health Organization Quality of Life scale - short version (WHO-QOL BREF)
Description
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
Time Frame
Baseline, week 4, and week 8
Title
Change in mood scores on the Positive and Negative Affect Schedule (PANAS)
Description
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
Time Frame
From baseline to week 8, one time per week
Title
Change in performance in the game
Description
Evaluate change in success rate, when improvement in performance measured by answering the level correctly
Time Frame
continuous use during the 8-week study
Title
Change in engagement levels
Description
Measured by change in the average play time (minutes) over the course of 8 weeks
Time Frame
continuous use during the 8-week study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola Pedrelli, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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A Treatment for Depression Via a Gamified Mobile Phone Application Based on a New Cognitive Model
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