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

NCT06880627 | Active Not Recruiting

• 1 other identifier: HUM00267401
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cognitive issues; Memory or Focus problems; Internet connected devices; Online group sessions; Online brain games; Surveys

Outcome Measures

Primary Outcomes (1)

• Change in objective cognitive function from baseline to week 8

  This will be assessed using the online platform BrainCheck. The following tests will be included: (1) Trail Making A \& B (attention and mental flexibility); (2) Stroop Color and Word test (executive function); (3) Digit-Symbol Substitution (processing speed); and (4) Immediate and Delayed Recognition tests (memory). A composite score will be calculated through BrainCheck to assess global cognitive function. The score range is 0-200 a higher score means greater cognitive function.

  Baseline, 8 weeks

Secondary Outcomes (5)

• Change in perceived cognitive function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) cognitive function ability 4a short form

  Baseline, 8 weeks

• Change in pain will be measured using the PROMIS pain interference short form

  Baseline, 8 weeks

• Change in fatigue will be measured using the PROMIS fatigue short form

  Baseline, 8 weeks

• Change in depressed mood will be measured using the PROMIS depression short form

  Baseline, 8 weeks

• Change in self-management will be evaluated using the Patient Activation Measure (PAM)

  Baseline, 8 weeks

Study Arms (2)

Brain Boost group

EXPERIMENTAL

Behavioral: Brain Boost group

Waitlist group

OTHER

Other: Waitlist group

Interventions

Brain Boost group BEHAVIORAL

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.

Brain Boost group

Waitlist group OTHER

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.

Waitlist group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have physician-diagnosis of Systemic sclerosis (SSc) (any subtype)
• 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

You may not qualify if:

• Diagnosis of dementia or head injury
• 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)

Sponsors & Collaborators

• University of Michigan: lead
• National Scleroderma Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Yen Chen, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be made available within two year of the study's conclusion and will remain accessible for at least five years.
• Access Criteria: Researchers requesting access to the data must submit a formal request detailing the intended use of the dataset. Access will be granted upon approval and execution of a data use agreement that ensures compliance with data confidentiality and ethical research practices. At this time, there is no designated online repository for data access. Researchers can request data by contacting the study team at yentchen@med.umich.edu.

Locations

US (1)