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
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.
Exclusion Criteria:
Behavioral: Targeted Cognitive Training Intervention
Behavioral: General 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.
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.
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)
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)
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)
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
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