Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis
NCT ID: NCT06880627
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2025-04-16
2027-06-30
Brief Summary
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The study team hypothesize that participants that receive the intervention will have better improvements immediately after treatment at week 8 in all cognitive function measures, non-cognitive symptoms, and self-management compared to those in the waitlist control.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Brain Boost group
Brain Boost group
There will be 8 group educational sessions over an 8-week program period to learn strategies for improving cognitive function. Participants will also be asked to engage in 20 minutes, at least 5 times per week online game-like cognitively stimulating activities to improve cognitive health. In addition, surveys will be completed as certain timepoints.
Waitlist group
Waitlist group
This group will continue to receive usual health and care routines. Participants will be asked to complete surveys at certain timepoints that are the same as the boost group. After the 6-month follow-up, participants will receive the intervention materials, which include 8 weekly educational session recordings with slides, 8 weeks' subscription to online brain games, and biweekly online office hours. The office hours, hosted by the principal investigator and a trained patient co-facilitator, will give participants a chance to discuss participant's progress and ask questions.
Interventions
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Brain Boost group
There will be 8 group educational sessions over an 8-week program period to learn strategies for improving cognitive function. Participants will also be asked to engage in 20 minutes, at least 5 times per week online game-like cognitively stimulating activities to improve cognitive health. In addition, surveys will be completed as certain timepoints.
Waitlist group
This group will continue to receive usual health and care routines. Participants will be asked to complete surveys at certain timepoints that are the same as the boost group. After the 6-month follow-up, participants will receive the intervention materials, which include 8 weekly educational session recordings with slides, 8 weeks' subscription to online brain games, and biweekly online office hours. The office hours, hosted by the principal investigator and a trained patient co-facilitator, will give participants a chance to discuss participant's progress and ask questions.
Eligibility Criteria
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Inclusion Criteria
* A score of ≥ 10 on the Perceived Deficits Questionnaire
* A score of ≤ 7 on the 6-Item Cognitive Impairment Test
* Have access to a reliable, internet-connected device (e.g. computer, smartphone, tablet)
* Visual acuity with correction sufficient to work on a computer, smartphone, tablet or screen
* Be able to read, speak, and understand English
Exclusion Criteria
* Other neurological disorders that might impact cognition
* Have major psychiatric disorder such as major depression and schizophrenia
* Complex, unstable health issues that would preclude full participation in the study (like a planned surgery or active cancer treatment)
18 Years
70 Years
ALL
No
Sponsors
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National Scleroderma Foundation
UNKNOWN
University of Michigan
OTHER
Responsible Party
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Yen T Chen, PhD
Research Assistant Professor
Principal Investigators
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Yen Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00267401
Identifier Type: -
Identifier Source: org_study_id
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