Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorAdventHealth
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 60+ years
Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Mini International Neuropsychiatric Interview
Montgomery-Åsberg Depression Rating Scale (MADRS) score > or = 16.
Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES > or = to 37)
Disqualifiers
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
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.
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).
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Targeted Cognitive Training Intervention
BehavioralIn 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.
General Cognitive Training Intervention
BehavioralIn 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Targeted Cognitive Training InterventionExperimental treatment 1 intervention
Group B: General Cognitive Training InterventionActive comparator 1 intervention
Trial outcomes
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
AdventHealth
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov