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Depression

Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics

Recruiting · Orlando, Florida

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Voluntary — you can stop anytime

What is 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.

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

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.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

  • Age 60 years or older.
  • Have unipolar major depressive disorder without psychotic features.
  • Have a depression score on the MADRS of 16 or higher (MADRS is a depression rating scale).
  • Have clinically significant apathy based on the Clinician-rated Apathy Evaluation Scale (C-AES score 37 or higher).
  • Can complete study steps, including written consent, following instructions in English, and having an MRI and computer/tablet with WiFi.

🚫 You may not be able to join if…

  • Have a psychiatric diagnosis other than major depressive disorder without psychotic features, persistent depressive disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia.
  • Take certain brain-acting medicines besides antidepressants or benzodiazepines (for example, cholinesterase inhibitors or antipsychotics), if they may affect the study results.
  • Have a significant neurologic or neurodegenerative disorder (examples include Alzheimer’s disease/dementias, mild cognitive impairment, stroke, multiple sclerosis, Parkinson’s disease, or epilepsy).
  • Have a serious acute medical condition that could affect brain systems or interfere with participation (examples given include severe heart, kidney, or breathing failure; severe COPD; metastatic cancer).
  • Have MRI scan contraindications (such as a pacemaker or metal implant) or cannot complete MRI due to issues like claustrophobia.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults roughly 60 and older
  • Have Depression
  • !Some conditions may not be a fit: COPD (chronic lung disease), Anxiety, Dementia / Alzheimer's, Parkinson's disease, Multiple sclerosis (MS)

What to expect, step by step

  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

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.

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT05877885 · Locations: Florida