Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06880627

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in objective cognitive function from baseline to week 8

    Time frame: Baseline, 8 weeks

    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.

Secondary outcomes

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

    Time frame: Baseline, 8 weeks

    The PROMIS short form evaluates concentration, sharpness, thinking speed, and memory functioning over the past 7 days on a 5-point Likert scale (1 = not at all to 5 = very much). The scores range from 4-20 with higher score indicating higher cognitive functioning. All PROMIS raw scores will be converted to T-scores, where a higher score indicates a greater degree of the domain assessed.

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

    Time frame: Baseline, 8 weeks

    This is a 4-item short form which assesses pain interference with daily activities, work around the home, social activities, and household chores on a 5-point Likert scale (1 = not at all to 5 = very much). The scores range from 4-20 with higher score indicating higher pain interference. All PROMIS raw scores will be converted to T-scores, where a higher score indicates a greater degree of the domain assessed.

  3. Change in fatigue will be measured using the PROMIS fatigue short form

    Time frame: Baseline, 8 weeks

    This is a 4-items short form which evaluates individuals' fatigue experience and its impact on participant's everyday lives using a 5-point Likert scale (1 = not at all to 5 = very much). The scores range from 4-20 with higher score indicating more fatigue. All PROMIS raw scores will be converted to T-scores, where a higher score indicates a greater degree of the domain assessed.

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

    Time frame: Baseline, 8 weeks

    This is a 4-item short form which assesses feelings of worthlessness, helplessness, depressed mood, and hopelessness on a 5-point Likert scale (1 = Never to 5 = Always). The scores range from 4-20 with higher score indicating more depressed mood. All PROMIS raw scores will be converted to T-scores, where a higher score indicates a greater degree of the domain assessed.

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

    Time frame: Baseline, 8 weeks

    This is a 13-item measure that assesses patient knowledge, skill, and confidence. Each item is scored from 1 (strongly disagree) to 4 (strongly agree). Scores range from 13 to 52, with higher scores indicating greater confidence and knowledge in patients managing participant's condition.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Scleroderma Foundation

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.