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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Individuals with Major Depressive Disorder who have access to an FTP-based mobile phone application for eight weeks. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression scores on the Montgomery-Ã…sberg 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined exclusion criteria applied.
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| Name | Affiliation | Role |
|---|---|---|
| Paola Pedrelli, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19819753 | Background | 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. | |
| 27122295 | Background | Baror 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| D003865 | Depressive Disorder, Major |
| D000079562 | Rumination Syndrome |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D005767 | Gastrointestinal Diseases |
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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.
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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 |
| 21852891 | Background | Fredrickson 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. |
| 11892776 | Background | Gasper 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. |
| 27553369 | Background | Harel 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. |
| 32059121 | Background | Herz 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. |
| 21823806 | Background | Mason 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. |
| 32628116 | Background | Patel 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. |
| 22418740 | Background | Thomas 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. |
| 39350528 | Derived | Yatziv 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. |
| D004066 |
| Digestive System Diseases |
| D001068 | Feeding and Eating Disorders |