Major Depressive DisorderNCT05877885
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
A study testing Targeted Cognitive Training Intervention and General Cognitive Training Intervention in people with Major Depressive Disorder and Apathy, run by AdventHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depressive Disorder, Apathy
- What is being tested?
- Targeted Cognitive Training Intervention and General Cognitive Training Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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.
- 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
- Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff.
- Total score of > 29 on the Telephone Interview for Cognitive Status (TICS)
- Eligible to undergo MRI
- Access to a computer or tablet with Wifi capabilities
- Able to comply with all testing and study requirements and willingness to participate in the full study duration.
Who cannot join
- 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.
- 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.
- Electroconvulsive therapy within the past 12 months
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- Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder.
- 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)
- Claustrophobia
- Color Blindness
- 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.
- Travelling consecutively for 2+ weeks during the study period to a location that will preclude timely collection of post-treatment MRI data.
- Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, cochlear implant, any other metallic biomedical implant contraindicating to MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AdventHealth Neuroscience Institute
Orlando, Florida, 32804
Lauren E Oberlin, PhD, (860) 690-8441, lauren.oberlin@adventhealth.com
Lauren Oberlin, PhD
About this study
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.
- Conditions
- Major Depressive Disorder, Apathy
- Being tested
- Targeted Cognitive Training Intervention, General Cognitive Training Intervention
- Medical subject headings
- Depressive Disorder, Major, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Cognitive Training InterventionBehavioural
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.
General Cognitive Training InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Cognitive Training Intervention | Experimental | Not described Receives: Behavioral: Targeted Cognitive Training Intervention |
| General Cognitive Training Intervention | Active comparator | Not described Receives: Behavioral: General Cognitive Training Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks
Calculated from resting state fMRI scan. Validation of target engagement.
Measured: Baseline and Post-treatment (Week 4)
Secondary outcomes (2)
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).
Measured: 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.
Measured: Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start19 Sep 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lauren Oberlin, PhD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877885
- Sponsor's protocol ID
- 22-09025304
- Other IDs
- K23MH129882
- Status last verified
- Oct 2025
- First submitted
- 17 May 2023
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that will be shared includes all of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
- ClinicalTrials.gov ID
- NCT05877885
- Acronym / sponsor ID
- 22-09025304
- Conditions
- Major Depressive Disorder, Apathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Cognitive Training Intervention | Experimental | Behavioral: Targeted Cognitive Training Intervention |
| General Cognitive Training Intervention | Active comparator | Behavioral: General Cognitive Training Intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
- 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.
Key exclusion criteria (13 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Cognitive Training InterventionIn 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. | Behavioural | Targeted Cognitive Training Intervention |
| General Cognitive Training InterventionIn 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. | Behavioural | General Cognitive Training Intervention |
Primary outcome
Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks
Time frame: Baseline and Post-treatment (Week 4)
Calculated from resting state fMRI scan. Validation of target engagement.
2 secondary outcomes
Change in Apathy Evaluation Scale (AES) score
Time frame: Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)
Change in Stroop Interference score
Time frame: Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: Yes. The data that will be shared includes all of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Oberlin, PhD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Cognitive Training Intervention and General Cognitive Training Intervention in people with Major Depressive Disorder and Apathy, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Oberlin, PhD ((860) 690-8441, lauren.oberlin@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks (time frame: Baseline and Post-treatment (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.