NCT06880627

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-04-16
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-03-18
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States