RecruitingNot ApplicableNCT05877885

Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics


Sponsor

AdventHealth

Enrollment

84 participants

Start Date

Sep 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized controlled trial is to evaluate the potential of a customized digital cognitive training intervention to target aspects of brain function in apathy of late-life depression and reduce symptoms of apathy and related cognitive and behavioral deficits. The investigators hypothesize that 4 weeks of a customized digital cognitive training program will lead to changes in brain connectivity, apathy severity, and cognitive control performance.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a digital therapeutic app (a structured brain-training program) can reduce apathy — a common symptom in older adults with late-life depression that makes it hard to feel motivated or interested in daily activities. The study uses brain scans (MRI) to understand how the treatment affects brain networks. **You may be eligible if...** - You are 60 years or older - You have a diagnosis of major depressive disorder (without psychotic features) - You are experiencing significant apathy (lack of motivation or interest) along with depression - Your depression score on a standard scale is 16 or above - You are not on antidepressants or have been on a stable dose for at least 8 weeks - You have access to a computer or tablet with Wi-Fi - You can safely have an MRI **You may NOT be eligible if...** - You have another psychiatric diagnosis such as bipolar disorder, psychosis, or PTSD - You have a history of stroke, dementia, Parkinson's disease, or other brain conditions - You are at risk for suicide or have attempted suicide in the past year - You have had electroconvulsive therapy in the past year - You have had a substance use disorder in the past 6 months - You have claustrophobia or cannot safely have an MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTargeted Cognitive Training Intervention

In this intervention, participants will complete 25-30 minutes of cognitive training per day, 5 days/week (but up to 7 days/week) for 4 weeks. The training protocol will be delivered via the Posit Science Platform, and includes tasks that emphasize training of sustained attention, salience detection, and dimensions of cognitive control. During the 4 week intervention, participants will have weekly 10-20 minute visits with a Care Manager to provide clinical monitoring of symptoms and structured support to participants.

BEHAVIORALGeneral Cognitive Training Intervention

In this intervention, participants will complete 25-30 minutes of cognitive activities per day, 5 days/week (but up to 7 days/week) for 4 weeks. The training protocol will be delivered via the Posit Science Platform. The intervention protocol will include computerized cognitive activities designed to provide general cognitive stimulation. During the 4 week intervention, participants will have weekly 10-20 minute visits with a Care Manager to provide clinical monitoring of symptoms and structured support to participants.


Locations(1)

AdventHealth Neuroscience Institute

Orlando, Florida, United States

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NCT05877885


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