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RecruitingNCT05877885Updated Oct 22, 2025

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

An interventional study of Targeted Cognitive Training Intervention and General Cognitive Training Intervention in Major Depressive Disorder and Apathy, sponsored by AdventHealth. Recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-10-22.

Sponsored by AdventHealth · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder
  • Apathy
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Targeted Cognitive Training Intervention

    Behavioral: Targeted Cognitive Training Intervention

  • Active comparator
    General Cognitive Training Intervention

    Behavioral: General Cognitive Training Intervention

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.

05

What researchers measure

Primary outcomes

  1. Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks

    Calculated from resting state fMRI scan. Validation of target engagement.

    Time frame: Baseline and Post-treatment (Week 4)

Secondary outcomes

  1. Change in Apathy Evaluation Scale (AES) score

    The 18-item clinician-rated version of the Apathy Evaluation Scale (AES) will be used to measure apathy severity. Scores range from 18 (no apathy) to 72 (severe apathy).

    Time frame: Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)

  2. Change in Stroop Interference score

    Stroop interference will be calculated from the computerized Stroop Task to measure cognitive control.

    Time frame: Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)

06

Study locations

1 of 1 sites recruiting
  • AdventHealth Neuroscience Institute
    Orlando, Florida 32804, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — The data that will be shared includes all of the individual participant data collected during the trial, after deidentification.

Supporting information: Study protocol, Icf, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05877885
Lead sponsor
AdventHealth
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
May 26, 2023
Start date
Sep 19, 2025
Primary completion
Nov 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Oct 22, 2025

Study contacts

Lauren Oberlin, PhD
Contact
lauren.oberlin@adventhealth.com
(860) 690-8441
Lauren Oberlin, PhD
principal investigator · AdventHealth

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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