Digital brain training to reduce apathy in late‑life depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares a customized targeted cognitive training program to a general cognitive training intervention over four weeks in older adults with major depressive disorder and clinically significant apathy. Participants complete computerized training at home using a tablet or computer, undergo cognitive testing, and have brain imaging (MRI) before and after the intervention to measure changes in network connectivity. Primary outcomes include changes in apathy severity (Clinician-rated Apathy Evaluation Scale), cognitive control performance, and brain connectivity measures, with depressive symptoms monitored by MADRS. Eligibility requires age 60+, sufficient cognitive status (TICS > 29), the ability to undergo MRI, and stable or no psychotropic medication changes prior to enrollment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 60+ years
2. Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Mini International Neuropsychiatric Interview
3. Montgomery-Åsberg Depression Rating Scale (MADRS) score \> or = 16.
4. Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES \> or = to 37)
5. 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.
6. 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.
7. Capacity to provide written consent for research assessment and treatment
8. Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff.
9. Total score of \> 29 on the Telephone Interview for Cognitive Status (TICS)
10. Eligible to undergo MRI
11. Access to a computer or tablet with Wifi capabilities
12. Able to comply with all testing and study requirements and willingness to participate in the full study duration.

Exclusion Criteria:

1. 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
2. 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.
3. 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).
4. 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.
5. 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.
6. Electroconvulsive therapy within the past 12 months
7. Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder.
8. 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)
9. Claustrophobia
10. Color Blindness
11. 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.
12. Travelling consecutively for 2+ weeks during the study period to a location that will preclude timely collection of post-treatment MRI data.
13. Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, cochlear implant, any other metallic biomedical implant contraindicating to MRI.

Where it's running

• AdventHealth Neuroscience Institute
  Orlando, Florida, United States Recruiting

Study contacts

• Principal investigator: Lauren Oberlin, PhD — AdventHealth
• Study coordinator: Lauren Oberlin, PhD
• Email: lauren.oberlin@adventhealth.com
• Phone: (860) 690-8441

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.