SclerodermaNCT06880627
Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis
A study testing Brain Boost group and Waitlist group in people with Scleroderma, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Scleroderma
- What is being tested?
- Brain Boost group and Waitlist group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Brain Boost group, Waitlist group
- Keywords
- Cognitive issues, Memory or Focus problems, Internet connected devices, Online group sessions, Online brain games, Surveys
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Boost groupBehavioural
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Brain Boost group | Experimental | Not described Receives: Behavioral: Brain Boost group |
| Waitlist group | Other | Not described Receives: Other: Waitlist group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, 8 weeks
Change in pain will be measured using the PROMIS pain interference short form
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.
Measured: Baseline, 8 weeks
Change in fatigue will be measured using the PROMIS fatigue short form
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.
Measured: Baseline, 8 weeks
Change in depressed mood will be measured using the PROMIS depression short form
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.
Measured: Baseline, 8 weeks
Change in self-management will be evaluated using the Patient Activation Measure (PAM)
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.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start16 Apr 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Scleroderma Foundation
- Responsible party
- Principal investigator, Yen T Chen, PhD, University of Michigan
- Investigators
- Yen Chen, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880627
- Sponsor's protocol ID
- HUM00267401
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified Individual participant data (IPD) will be shared upon request. The shared dataset will include objective cognitive function data, as well as self-report symptom-related data such as pain, anxiety, depressed mood, sleep disturbance, and perceived self-management improvement. Data will be provided in a format that ensures participant confidentiality and compliance with ethical guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT06880627
- Acronym / sponsor ID
- HUM00267401
- Conditions
- Scleroderma
- Keywords
- Cognitive issues, Memory or Focus problems, Internet connected devices, Online group sessions, Online brain games, Surveys
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Scleroderma Foundation
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Boost group | Experimental | Behavioral: Brain Boost group |
| Waitlist group | Other | Other: Waitlist group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Boost groupThere 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. | Behavioural | Brain Boost group |
| Waitlist groupThis 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. | Other | Waitlist group |
Primary outcome
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.
5 secondary outcomes
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
Change in pain will be measured using the PROMIS pain interference short form
Time frame: Baseline, 8 weeks
Change in fatigue will be measured using the PROMIS fatigue short form
Time frame: Baseline, 8 weeks
Change in depressed mood will be measured using the PROMIS depression short form
Time frame: Baseline, 8 weeks
Change in self-management will be evaluated using the Patient Activation Measure (PAM)
Time frame: Baseline, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified Individual participant data (IPD) will be shared upon request. The shared dataset will include objective cognitive function data, as well as self-report symptom-related data such as pain, anxiety, depressed mood, sleep disturbance, and perceived self-management improvement. Data will be provided in a format that ensures participant confidentiality and compliance with ethical guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen Chen, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Boost group and Waitlist group in people with Scleroderma, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in objective cognitive function from baseline to week 8 (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.