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Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis

NCT06880627 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-28

No results posted yet for this study

Summary

The purpose of this study is to examine whether an 8-week online educational group-based program tailored to people with systemic sclerosis can help improve cognitive function and well-being.

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.

Conditions

  • Scleroderma

Interventions

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Yen Chen, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-16
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06880627 on ClinicalTrials.gov