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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The objectives of this study are to determine if the 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress' (TEAM-LEADS) intervention is feasible and acceptable to adolescents and young adults with lupus and dermatomyositis and whether it can help reduce stress and promote cardiovascular health behaviors in these individuals.

Research Team

Kaveh Ardalan, MD, MS

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+