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

NCT05685758 | Completed

• 1 other identifier: 2022P002100
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depressive Disorder; Clinical Depression; Major Depressive Disorder

Keywords

Depression; Ruminations; Mobile-app; Therapeutic Game; FTP; Digital Health; Mood Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Change in depression symptoms severity on the Patient Health Questionnaire (PHQ-9)

  From baseline to week 8, one time per week

• Change in depression symptoms severity on the Symptoms of Depression Questionnaire (SDQ)

  Baseline, week 4, and week 8

• Change in anxiety measure on the General Anxiety Disorder-7 (GAD-7)

  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)

  Baseline, week 4, and week 8

• Change in mood scores on the Positive and Negative Affect Schedule (PANAS)

  From baseline to week 8, one time per week

Study Arms (2)

Intervention group

EXPERIMENTAL

Individuals with Major Depressive Disorder who have access to an FTP-based mobile phone application for eight weeks.

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.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hedonia Ltd: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (10)

• 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.

  PMID: 19819753 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.

  PMID: 27122295 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.

  PMID: 21852891 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.

  PMID: 11892776 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.

  PMID: 27553369 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.

  PMID: 32059121 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.

  PMID: 21823806 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.

  PMID: 32628116 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.

  PMID: 22418740 BACKGROUND

• 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.

  PMID: 39350528 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major; Rumination Syndrome; Mood Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders

Study Officials

• Paola Pedrelli, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Assistant Professor Harvard Medical School, Associate Director Depression Clinical Research Program

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 17, 2023
• Study Start: November 3, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)