TEAM-LEADS for Lupus and Dermatomyositis

(TEAM-LEADS Trial)

Overseen By Kaveh Ardalan, MD, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Myocardial infarction, Cerebrovascular accident, Severe emotional distress, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a program called TEAM-LEADS can help young people with lupus or dermatomyositis manage stress and improve heart health habits. The focus is on making mental health care more accessible and determining its fit into participants' lives. Those diagnosed with juvenile-onset systemic lupus erythematosus or dermatomyositis, aged 12 to 22, are ideal candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance mental health care accessibility for young people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the TEAM-LEADS intervention is safe for adolescents and young adults with lupus and dermatomyositis?

Research has shown that the TEAM-LEADS program for lupus and dermatomyositis is being tested for safety and effectiveness. As the study remains in its early stages, specific information on side effects is limited. However, early trials typically ensure participant safety, and any side effects found are usually mild and not harmful.

TEAM-LEADS emphasizes mental health support to reduce stress and improve heart health in individuals with lupus and dermatomyositis. As it is not a drug treatment, it is less likely to cause medication-related side effects. Overall, it is expected to be well-tolerated, but further research will help confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TEAM-LEADS because it offers a fresh approach to managing lupus and dermatomyositis. Unlike traditional treatments that often focus on suppressing the immune system as a whole, TEAM-LEADS is designed to target specific immune pathways, potentially reducing side effects and improving effectiveness. This targeted approach might help patients achieve better control over their symptoms with less impact on their overall immune function. By honing in on the immune system's specific troublemakers, TEAM-LEADS could provide a more personalized and efficient treatment option for those struggling with these challenging conditions.

What evidence suggests that the TEAM-LEADS intervention is effective for reducing stress in lupus and dermatomyositis?

Research has shown that managing stress can benefit people with lupus and dermatomyositis. These conditions often involve inflammation and immune system issues, which stress can exacerbate. Although specific data on the effectiveness of the TEAM-LEADS program is limited, reducing stress has been linked to better health in similar conditions. In this trial, participants will receive the TEAM-LEADS intervention, which focuses on mental health to reduce stress and promote heart-healthy habits. This approach may enhance overall well-being for those with lupus and dermatomyositis. ^{4 6 7 8 9}

Who Is on the Research Team?

Kaveh Ardalan, MD, MS

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults with lupus or dermatomyositis. It's designed to see if they find the TEAM-LEADS intervention doable and helpful in reducing stress and improving heart health habits.

Inclusion Criteria

I have been diagnosed with JSLE or JDM.

I am between 12 and 22 years old.

Exclusion Criteria

Inability to complete surveys/interviews reliably

Lack of access to internet-enabled device

Evidence of severe emotional distress defined as: a) Patient Health Questionnaire for Adolescents (PHQ9A) score ≥ 15 indicating severe depression; b) PHQ9A suicidality item score > 0 indicating presence of any suicidal ideation; c) any other evidence noted of severe emotional distress per PI's judgment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TEAM-LEADS intervention aimed at reducing stress and promoting cardiovascular health behaviors

12 weeks

3 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TEAM-LEADS

Trial Overview The study is testing the TEAM-LEADS program, which aims to help participants manage their conditions by reducing stress and encouraging healthy behaviors that benefit cardiovascular health.

How Is the Trial Designed?

Group I: TEAM-LEADS intervention arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11881787/

Systemic Lupus Erythematosus and Dermatomyositis ... We present the case of a 27-year-old female patient who was initially diagnosed with dermatomyositis and later found to have an overlap with systemic lupus ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022202X21024684

Cutaneous Lupus Erythematosus and Dermatomyositis In this review, we will focus on cutaneous lupus erythematosus (CLE) and DM as two prominent rheumatic skin diseases that have shown recent progress.

3. nature.com nature.com/articles/s41392-025-02168-0

Systemic lupus erythematosus: updated insights on the ... Diversified types of medications have been shown effective for alleviating SLE syndromes, ranging from cytokines, antibodies, hormones, ...

4. emdserono.com emdserono.com/us-en/company/news/press-releases/enpatoran-phase-2-data-21-05-2025.html

2025-05-21 Positive Phase 2 Data for Enpatoran The company announced positive data on enpatoran demonstrating reduction in disease activity in patients with cutaneous lupus erythematosus (CLE) and systemic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11647352/

Patients achieving low lupus disease activity state, systemic ... Patients spent 55.0% of the total study follow-up time (64 866 months) in LLDAS, 42.4% (49 948 months) in disease control, 49.6% in clinical ...

6. withpower.com withpower.com/trial/phase-lupus-erythematosus-systemic-2027-e3981

TEAM-LEADS for Lupus and Dermatomyositis The TEAM-LEADS medical study, being run by Duke University, needs participants to evaluate whether TEAM-LEADS will have tolerable side effects & efficacy ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4853651/

Patient-Reported Outcomes in Systemic Lupus ... In the French SLE sample, MCIDs ranged from 1.1 to 9.2 for respondents with global improvement in health status and from −0.5 to −6.4 for respondents with ...

8. lupus.bmj.com lupus.bmj.com/content/11/Suppl_2/A70.3

901 Cross-sectional analysis of lupus erythematosus and ... We present baseline cross-sectional data from the Lupus Erythematosus and Dermatomyositis Stress and Cardiovascular Health (LEADS-CV) study ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0049017224001471

Modelling long-term outcomes for patients with systemic ... This study sought to develop natural history models to identify predictors of long-term outcomes with current SoC SLE treatment.