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

Not Applicable

Recruiting

• Conditions: Scleroderma

• Registration Number: NCT06880627
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Study First Posted: 2025-03-18
• Study Start: 2025-04-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in objective cognitive function from baseline to week 8	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 Outcome Measures

Name	Time	Method
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	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.
Change in pain will be measured using the PROMIS pain interference short form	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.
Change in depressed mood will be measured using the PROMIS depression short form	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.
Change in fatigue will be measured using the PROMIS fatigue short form	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.
Change in self-management will be evaluated using the Patient Activation Measure (PAM)	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States