Intervention group for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Depression+3 MoreFTP-based therapeutic mobile-app - Other
Eligibility
20 - 50
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Depression

Treatment Effectiveness

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Baseline, week 4, and week 8

Week 8
Change in depression scores on the Montgomery-Åsberg Depression Rating Scale (MADRS clinical assessment)
Change in depression symptoms severity on the Symptoms of Depression Questionnaire (SDQ)
Change in quality of life score as assessed by the World Health Organization Quality of Life scale - short version (WHO-QOL BREF)
Week 8
Change in Anhedonia level on the Snaith-Hamilton Pleasure Scale (SHAPS)
Change in anxiety measure on the General Anxiety Disorder-7 (GAD-7)
Change in breadth of thought and ruminations scores on the Ruminative Response Scale (RRS)
Change in depression symptoms severity on the Patient Health Questionnaire (PHQ-9)
Change in mood scores on the Positive and Negative Affect Schedule (PANAS)
continuous use during the 8-week study
Change in engagement levels
Change in performance in the game

Trial Safety

Trial Design

2 Treatment Groups

Control group
1 of 2
Intervention group
1 of 2

Active Control

Experimental Treatment

110 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention group · No Placebo Group · N/A

Intervention group
Other
Experimental Group · 1 Intervention: FTP-based therapeutic mobile-app · Intervention Types: Other
Control groupNoIntervention Group · 1 Intervention: Control group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 4, and week 8

Who is running the clinical trial?

Hedonia LtdLead Sponsor
Paola Pedrelli, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
96 Total Patients Enrolled
1 Trials studying Depression
96 Patients Enrolled for Depression

Eligibility Criteria

Age 20 - 50 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are capable of comprehending and signing a written agreement in English.
Participants currently undergoing treatment should have been with the same therapist for a period of two months or longer, and must not intend to modify their therapy regimen during the eight-week duration of this study.
You have been diagnosed with either Major Depressive Disorder or mild depression, and your score on the Montgomery-Åsberg Depression Rating Scale is between 15 to 35.
Participants must have been taking any FDA approved or off-label medications for mood or anxiety consistently, without plans to alter dosage, for the past 6 weeks and throughout the 8 week study duration.
You are the exclusive user of either an iPhone or Android device and consent to downloading & utilizing the relevant mobile app as per protocol.
You are proficient in utilizing apps and games on your mobile device.
You must be a consenting adult aged between 20 and 50 years old to participate.

Who else is applying?

What state do they live in?
Michigan100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References