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TEAM-LEADS for Stress in Lupus and Dermatomyositis

This study is testing an online program called TEAM-LEADS. This program aims to help young people with juvenile-onset systemic lupus erythematosus (JSLE) or juvenile dermatomyositis (JDM) reduce stress and improve heart health behaviors. Researchers want to see if TEAM-LEADS is practical and helpful for individuals aged 13 to 22 who have these conditions. Success in this study will be measured by changes in how participants report their psychological stress levels over about three months. The study is currently unclear on its recruitment status, but plans to enroll 25 participants.

Study design
This is a Phase I open-label, single-arm pilot study, meaning all 25 participants will receive the TEAM-LEADS intervention. It will be conducted in successive groups.
What's involved
You would complete an online intervention and assessments at the beginning of the study, after the intervention, and at a follow-up visit on day 84.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for about 84 days after the baseline visit.

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NCT06999109

Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress

Not Yet Recruiting
NAAges 13–22InterventionalSupportive care
Duke University
~25 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:TEAM-LEADS

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Patient-Reported Outcome Measures Information System (PROMIS) Pediatric Psychological Stress Experiences (version 1.0 Short Form 8a) T-scores
Measured over From T1 (baseline visit, day 0) to T3 (Day 84)

Conditions

Lupus
Dermatomyositis, Juvenile
Dermatomyositis
Lupus Erythematosus
Lupus Erythematosus, Systemic
Lupus or SLE

Explore related trials

DermatomyositisSystemic Lupus Erythematosus

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Kaveh Ardalan, MD, MS · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Kaveh Ardalan, MD, MS
[email protected]
919-684-6575
Email the study team

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Eligibility criteria

Inclusion

Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM)
Age 13-22 years old at time of enrollment

Exclusion

Inability to complete surveys/interviews reliably
Lack of access to internet-enabled device;
Non-JSLE/JDM diagnosis
History of myocardial infarction or cerebrovascular accident
Evidence of severe emotional distress defined as any of the following at time of screening: 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.

What this trial measures

  • Change in Patient-Reported Outcome Measures Information System (PROMIS) Pediatric Psychological Stress Experiences (version 1.0 Short Form 8a) T-scoresFrom T1 (baseline visit, day 0) to T3 (Day 84)

    T-scores range from 37 to 81.8. Higher T-scores indicate greater psychological stress (i.e. worse outcome).