Actively Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Led by AdventHealth · Updated on 2025-10-22
84
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
Sponsors
A
AdventHealth
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Diagnosis of unipolar major depressive disorder without psychotic features
- Montgomery-Åsberg Depression Rating Scale (MADRS) score 16 or higher
- Clinically significant apathy with Clinician-rated Apathy Evaluation Scale (C-AES) score 37 or higher
- Off antidepressants or on stable antidepressant dose for at least 8 weeks with no planned changes for 5 weeks
- Stable dose of other psychotropic medications affecting brain networks for at least 8 weeks
- Ability to provide written consent for research
- Ability to understand and follow written and verbal instructions in English
- Total Telephone Interview for Cognitive Status (TICS) score above 29
- Eligible for MRI scanning
- Access to a computer or tablet with Wifi
- Able and willing to comply with all study requirements and duration
You will not qualify if you...
- Psychiatric diagnoses other than major depressive disorder without psychotic features, persistent depressive disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia
- Use of cholinesterase inhibitors or psychoactive drugs other than antidepressants or benzodiazepines that may affect study data
- Significant neurological or neurodegenerative disorders including Alzheimer's disease, dementias, amnestic Mild Cognitive Impairment, stroke, Multiple Sclerosis, Parkinson's disease, or epilepsy
- Acute medical conditions affecting brain systems or participation such as cardiac, renal, respiratory failure, severe COPD, metastatic cancer, or debilitated states
- Current risk of suicide, recent suicide attempt within past year, or active suicidal ideation or self-injurious behavior
- Electroconvulsive therapy within past 12 months
- Substance Use Disorder within 6 months prior to screening
- Current participation in cognitive rehabilitation (psychotherapy allowed)
- Claustrophobia
- Color blindness
- Sensory or physical impairments that prevent cognitive testing or participation (e.g., upper limb paralysis)
- Planned travel of 2 or more consecutive weeks during study preventing timely post-treatment MRI
- Contraindications to MRI including cardiac pacemaker, heart valve replacement, vascular stent, cochlear implant, or other metallic biomedical implants contraindicated for MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AdventHealth Neuroscience Institute
Orlando, Florida, United States, 32804
Actively Recruiting
Research Team
L
Lauren Oberlin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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