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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH129882 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Cognitive Training Intervention | Experimental |
| |
| General Cognitive Training Intervention | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted Cognitive Training Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks | Calculated from resting state fMRI scan. Validation of target engagement. | Baseline and Post-treatment (Week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4) |
| Change in Stroop Interference score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Oberlin, PhD | Contact | (860) 690-8441 | lauren.oberlin@adventhealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Lauren Oberlin, PhD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Neuroscience Institute | Recruiting | Orlando | Florida | 32804 | United States |
The data that will be shared includes all of the individual participant data collected during the trial, after deidentification.
Beginning 3 months following publication of primary outcomes, ending 5 years following publication of primary outcomes.
Data will be made available to researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal. Proposals should be directed to the study PI, Lauren Oberlin, at lauren.oberlin@adventhealth.com
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D053609 | Lethargy |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| General Cognitive Training Intervention | Behavioral | 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. |
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Stroop interference will be calculated from the computerized Stroop Task to measure cognitive control. |
| Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4) |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |