Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Targeted Cognitive Training Intervention
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Behavioral: Targeted 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.
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| Active Comparator: General Cognitive Training Intervention
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Behavioral: General 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.
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Outcome Measures
Primary Outcome Measures
- Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks [Baseline and Post-treatment (Week 4)]
Calculated from resting state fMRI scan. Validation of target engagement.
Secondary Outcome Measures
- Change in Apathy Evaluation Scale (AES) score [Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)]
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).
- Change in Stroop Interference score [Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)]
Stroop interference will be calculated from the computerized Stroop Task to measure cognitive control.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 60+ years
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Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Structured Clinical Interview for DSM-5 (SCID)
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Montgomery-Åsberg Depression Rating Scale (MADRS) score > or = 16.
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Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES > or = to 37)
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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.
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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.
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Capacity to provide written consent for research assessment and treatment
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Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff.
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DRS total score > 129 or DRS scaled score of 5 based on age and education-adjusted normative data49
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Eligible to undergo MRI
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Access to a computer or tablet with Wifi capabilities
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Able to comply with all testing and study requirements and willingness to participate in the full study duration.
Exclusion Criteria:
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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
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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.
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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).
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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.
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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.
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Electroconvulsive therapy within the past 12 months
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Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder.
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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)
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Claustrophobia
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Color Blindness
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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.
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Travelling consecutively for 2+ weeks during the study period to a location that will preclude timely collection of post-treatment MRI data.
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Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, cochlear implant, any other metallic biomedical implant contraindicating to MRI.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lauren Elizabeth Oberlin | New York | New York | United States | 10065 |
| 2 | Weill Cornell Medicine Institute of Geriatric Psychiatry | White Plains | New York | United States | 10605 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Lauren Oberlin, PhD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-09025304
- K23MH129882