DepressionFTPNCT05685758
A Treatment for Depression Via a Gamified Mobile Phone Application Based on a New Cognitive Model
A study testing FTP-based therapeutic mobile-app in people with Depression and Depressive Disorder, run by Hedonia Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Depression, Depressive Disorder, Clinical Depression
- What is being tested?
- FTP-based therapeutic mobile-app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Being tested
- FTP-based therapeutic mobile-app
- Keywords
- Depression, Ruminations, Mobile-app, Therapeutic Game, FTP, Digital Health, Mood Disorders
- Medical subject headings
- Depression, Depressive Disorder, Depressive Disorder, Major, Rumination Syndrome, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTP-based therapeutic mobile-appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Individuals with Major Depressive Disorder who have access to an FTP-based mobile phone application for eight weeks. Receives: Other: FTP-based therapeutic mobile-app |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: From baseline to week 8, one time per week
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: continuous use during the 8-week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start3 Nov 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hedonia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Paola Pedrelli, Massachusetts General Hospital
- Investigators
- Paola Pedrelli, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685758
- Sponsor's protocol ID
- 2022P002100
- Acronym
- FTP
- Status last verified
- Oct 2023
- First submitted
- 15 Dec 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bar M. A cognitive neuroscience hypothesis of mood and depression. Trends Cogn Sci. 2009 Nov;13(11):456-63. doi: 10.1016/j.tics.2009.08.009. Epub 2009 Oct 12.
PubMed 19819753Baror S, Bar M. Associative Activation and Its Relation to Exploration and Exploitation in the Brain. Psychol Sci. 2016 Jun;27(6):776-89. doi: 10.1177/0956797616634487. Epub 2016 Apr 27.
PubMed 27122295Fredrickson BL, Branigan C. Positive emotions broaden the scope of attention and thought-action repertoires. Cogn Emot. 2005 May 1;19(3):313-332. doi: 10.1080/02699930441000238.
PubMed 21852891Gasper K, Clore GL. Attending to the big picture: mood and global versus local processing of visual information. Psychol Sci. 2002 Jan;13(1):34-40. doi: 10.1111/1467-9280.00406.
PubMed 11892776Harel EV, Tennyson RL, Fava M, Bar M. Linking major depression and the neural substrates of associative processing. Cogn Affect Behav Neurosci. 2016 Dec;16(6):1017-1026. doi: 10.3758/s13415-016-0449-9.
PubMed 27553369Herz N, Baror S, Bar M. Overarching States of Mind. Trends Cogn Sci. 2020 Mar;24(3):184-199. doi: 10.1016/j.tics.2019.12.015. Epub 2020 Feb 6.
PubMed 32059121Mason MF, Bar M. The effect of mental progression on mood. J Exp Psychol Gen. 2012 May;141(2):217-21. doi: 10.1037/a0025035. Epub 2011 Aug 8.
PubMed 21823806Patel S, Akhtar A, Malins S, Wright N, Rowley E, Young E, Sampson S, Morriss R. The Acceptability and Usability of Digital Health Interventions for Adults With Depression, Anxiety, and Somatoform Disorders: Qualitative Systematic Review and Meta-Synthesis. J Med Internet Res. 2020 Jul 6;22(7):e16228. doi: 10.2196/16228.
PubMed 32628116Thomas C, Kveraga K, Huberle E, Karnath HO, Bar M. Enabling global processing in simultanagnosia by psychophysical biasing of visual pathways. Brain. 2012 May;135(Pt 5):1578-85. doi: 10.1093/brain/aws066. Epub 2012 Mar 14.
PubMed 22418740Yatziv SL, Pedrelli P, Baror S, DeCaro SA, Shachar N, Sofer B, Hull S, Curtiss J, Bar M. Facilitating Thought Progression to Reduce Depressive Symptoms: Randomized Controlled Trial. J Med Internet Res. 2024 Nov 7;26:e56201. doi: 10.2196/56201.
PubMed 39350528
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treatment for Depression Via App-Based FTP (Game4Mood Study)
- ClinicalTrials.gov ID
- NCT05685758
- Acronym / sponsor ID
- FTP / 2022P002100
- Keywords
- Depression, Ruminations, Mobile-app, Therapeutic Game, FTP, Digital Health, Mood Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Hedonia LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: FTP-based therapeutic mobile-appIndividuals with Major Depressive Disorder who have access to an FTP-based mobile phone application for eight weeks. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FTP-based therapeutic mobile-appParticipants 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. | Other | Intervention group |
Primary outcome
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
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
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
7 secondary outcomes
Change in depression symptoms severity on the Patient Health Questionnaire (PHQ-9)
Time frame: 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
Change in anxiety measure on the General Anxiety Disorder-7 (GAD-7)
Time frame: 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
Change in mood scores on the Positive and Negative Affect Schedule (PANAS)
Time frame: From baseline to week 8, one time per week
Change in performance in the game
Time frame: continuous use during the 8-week study
Change in engagement levels
Time frame: continuous use during the 8-week study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Background: PubMed 19819753Bar M. A cognitive neuroscience hypothesis of mood and depression. Trends Cogn Sci. 2009 Nov;13(11):456-63. doi: 10.1016/j.tics.2009.08.009. Epub 2009 Oct 12.
- Background: PubMed 27122295Baror S, Bar M. Associative Activation and Its Relation to Exploration and Exploitation in the Brain. Psychol Sci. 2016 Jun;27(6):776-89. doi: 10.1177/0956797616634487. Epub 2016 Apr 27.
- Background: PubMed 21852891Fredrickson BL, Branigan C. Positive emotions broaden the scope of attention and thought-action repertoires. Cogn Emot. 2005 May 1;19(3):313-332. doi: 10.1080/02699930441000238.
- Background: PubMed 11892776Gasper K, Clore GL. Attending to the big picture: mood and global versus local processing of visual information. Psychol Sci. 2002 Jan;13(1):34-40. doi: 10.1111/1467-9280.00406.
- Background: PubMed 27553369Harel EV, Tennyson RL, Fava M, Bar M. Linking major depression and the neural substrates of associative processing. Cogn Affect Behav Neurosci. 2016 Dec;16(6):1017-1026. doi: 10.3758/s13415-016-0449-9.
- Background: PubMed 32059121Herz N, Baror S, Bar M. Overarching States of Mind. Trends Cogn Sci. 2020 Mar;24(3):184-199. doi: 10.1016/j.tics.2019.12.015. Epub 2020 Feb 6.
- Background: PubMed 21823806Mason MF, Bar M. The effect of mental progression on mood. J Exp Psychol Gen. 2012 May;141(2):217-21. doi: 10.1037/a0025035. Epub 2011 Aug 8.
- Background: PubMed 32628116Patel S, Akhtar A, Malins S, Wright N, Rowley E, Young E, Sampson S, Morriss R. The Acceptability and Usability of Digital Health Interventions for Adults With Depression, Anxiety, and Somatoform Disorders: Qualitative Systematic Review and Meta-Synthesis. J Med Internet Res. 2020 Jul 6;22(7):e16228. doi: 10.2196/16228.
- Background: PubMed 22418740Thomas C, Kveraga K, Huberle E, Karnath HO, Bar M. Enabling global processing in simultanagnosia by psychophysical biasing of visual pathways. Brain. 2012 May;135(Pt 5):1578-85. doi: 10.1093/brain/aws066. Epub 2012 Mar 14.
- Derived from this study: PubMed 39350528Yatziv SL, Pedrelli P, Baror S, DeCaro SA, Shachar N, Sofer B, Hull S, Curtiss J, Bar M. Facilitating Thought Progression to Reduce Depressive Symptoms: Randomized Controlled Trial. J Med Internet Res. 2024 Nov 7;26:e56201. doi: 10.2196/56201.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Pedrelli, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FTP-based therapeutic mobile-app in people with Depression and Depressive Disorder, run by Hedonia Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression scores on the Montgomery-Åsberg Depression Rating Scale (MADRS clinical assessment) (time frame: Baseline, week 4, and week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05685758, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.