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Depression

A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

Recruiting · New York, New York

PHASE2

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Study care at no cost to you

For your time and travel

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Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the efficacy of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies.

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

Read the full clinical description

Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the efficacy of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies. The hypotheses are that this treatment will improve cognitive skills, depression symptoms, daily function, and brain connectivity. In the short-term, the findings will inform the efficacy of the intervention and in the long-term, may support the use of the intervention to improve co-occurring cognitive and mood difficulties after stroke.

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…

  • Had a first stroke at least 6 months before starting the study
  • Has executive dysfunction (thinking/executive problems) on screening, based on age-adjusted test results
  • Has a Major Depressive Episode diagnosed using the SCID (Structured Clinical Interview for DSM-5)
  • Has at least moderate depression symptoms (Montgomery Asberg Depression Rating Scale score ≥ 18)
  • Can operate an iPad and use a pen, based on self-report and observation

🚫 You may not be able to join if…

  • Has receptive aphasia (difficulty understanding language) based on NIH Stroke Scale item 9 score of 2 or 3
  • Has dysarthria that makes speech unintelligible (NIHSS item 10 score of 2)
  • Has severe vision impairment or hemispatial neglect (NIHSS item 3 score of 3 or NIHSS item 11 score of 2)
  • Is enrolled in ongoing concurrent cognitive rehabilitation (but being in psychotherapy alone is not a reason to exclude)
  • Cannot take part in the study in a safe/appropriate way per the study doctor’s initial screening (PI judgment), including pregnancy

Are you a good fit?

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

  • Adults roughly 50–79
  • Have Depression
  • !Not for people who are pregnant or breastfeeding

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?

Yes. This treatment has already been through earlier human studies for safety before reaching this stage.

What you need to know before you apply

What is this study testing?+

Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the efficacy of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies.

Is it safe? Who makes sure of that?+

This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. 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.

Source: ClinicalTrials.gov · NCT05507138 · Locations: New York