RightFit
RecruitingPhase 2

A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

Efficacy and Target Engagement of a Digital Intervention to Improve Depression and Executive Dysfunction After Stroke

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 79 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The secondary hypothesis is that individuals randomized to the intervention arm will demonstrate greater increase in the functional connectivity of the executive control network (ECN, assessed with an MRI scan) at the conclusion of treatment, relative to participants randomized to the comparator arm."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an iPad brain-training program combined with learning ways to manage thinking problems. It is for people who have depression and trouble with thinking skills after a stroke. Researchers will test whether it improves thinking, mood, daily activities, and how parts of the brain connect.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Had your first stroke at least 6 months before the study starts.
  • Have trouble with planning, organizing, or other thinking skills, based on screening tests.
  • Have a major episode of depression, diagnosed through an interview.
  • Have at least moderate depression symptoms, with a score of 18 or higher on the study’s depression scale.
  • Can move well enough to use an iPad and a pen.
  • If taking medicine for depression, have taken the same dose for at least 8 weeks before joining.
  • Can follow all testing and study rules and are willing to take part for the full study.

Who can't join

  • Have trouble understanding language or speech that cannot be understood, based on study tests, or are not fluent in English.
  • Have severe vision loss or trouble noticing things on one side of your surroundings, based on study tests.
  • Are already in a program to improve thinking skills. Talk therapy alone does not rule you out.
  • Have or have had a major brain or nerve disorder other than stroke, or have dementia that makes you need help with basic daily tasks because of thinking problems.
  • Have a history of psychosis (trouble knowing what is real) or mania (unusually high mood and energy), or currently have thoughts of suicide.
  • Have thinking problems too severe to use an iPad, or depression severe enough to need a higher level of care or an immediate mental health referral.
  • Are pregnant.
  • Have another health or medical reason that the lead study doctor believes makes the study unsuitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * first-time stroke that occurred 6 months or more prior to study initiation * executive dysfunction as defined by a score of less than 1 standard deviation below age-adjusted normative score on at least one test of executive function in the screening assessment * diagnosis of Major Depressive Episode assessed by the Structured Clinical Interview for the DSM-5 (SCID). * at least moderate depressive symptoms as defined by Montgomery Asberg Depression Rating Scale ≥ 18 * motor function sufficient to operate an iPad and use a pen, based on self-report and observation * if treated with an antidepressant medication, must be on a stable dose for a minimum of 8 weeks at the time of study enrollment. * able to adhere to all testing and study requirements and willingness to participate in the full study duration Exclusion Criteria: * receptive aphasia as determined by a score of 2 or 3 on the NIH Stroke Scale \[NIHSS\] item 9 ("Best Language") * dysarthria that makes speech unintelligible (score of 2 on NIHSS item #10) * severe visual impairment or hemispatial neglect (score of 3 on NIHSS item #3 or score of 2 on NIHSS item #11) * patient already enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is already enrolled in psychotherapy, this will not be grounds for exclusion) * non-fluency in English * presence of or history of significant neurologic or neurodegenerative disorder other than stroke * presence of dementia based on dependence in basic ADLs due to cognitive deficits * history of psychosis or mania (evaluated using the SCID). * active suicide ideation (assessed via the Columbia Suicide Severity Rating Scale) * severe executive dysfunction (based on clinical judgment during screening evaluation) precluding use of the iPad * severe depression-even in the absence of active suicidal ideation-based on the screening evaluation and clinical judgment of the PI, which warrants a higher level of care and/or immediate referral to psychiatric services. * pregnancy * any other clinical or medical reason in the PI's initial screening evaluation that suggests the study is not appropriate for the participant.

Study sites (1)

NY