Digital cognitive training for apathy in older adults with late-life depression

Trial details

Who runs it

AdventHealth

Trial code

NCT05877885

Record updated

6 November 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Age 60+ years; Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Mini International Neuropsychiatric Interview; Montgomery-Åsberg Depression Rating Scale (MADRS) score > or = 16; Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES > or = to 37); Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 5 weeks; On a stable dose of other psychotropic medications, deemed by the investigator to be associated with brain networks of interest, for at least 8 weeks; Capacity to provide written consent for research assessment and treatment; Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff; Total score of > 29 on the Telephone Interview for Cognitive Status (TICS); Eligible to undergo MRI; Access to a computer or tablet with Wifi capabilities; Able to comply with all testing and study requirements and willingness to participate in the full study duration.

Exclusion: Use of cholinesterase inhibitors or psychoactive drugs other than antidepressants or benzodiazepines, including antipsychotics, that in the opinion of the Investigator may confound study data/assessments; Electroconvulsive therapy within the past 12 months; Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder; Participant is currently enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is enrolled in psychotherapy, this will not be grounds for exclusion); History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, persistent depressive disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia; Presence or history of significant neurologic or neurodegenerative disorder (e.g., Alzheimer's disease and other dementias, amnestic Mild Cognitive Impairment, history of stroke, Multiple Sclerosis, Parkinson's disease, epilepsy); Any other acute medical condition (e.g., cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses) that may influence brain systems of interest or interfere with participation or interpretation of the study results; Sensory or physical impairment that would preclude cognitive testing or participation in the intervention (e.g., upper limb paralysis) as reported by the participant or observed by the Investigator; Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, cochlear implant, any other metallic biomedical implant contraindicating to MRI; Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior; Claustrophobia; Color Blindness; Travelling consecutively for 2+ weeks during the study period to a location that will preclude timely collection of post-treatment MRI data.

ClinicalTrials.gov NCT05877885