ClinicalTrials.gov record NCT06999109

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age13 years old to 22 years old

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This pilot interventional study will test TEAM-LEADS, an online self-administered program for stress reduction and promotion of heart-healthy behaviors in adolescents and young people with juvenile-onset systemic lupus erythematosus or dermatomyositis. It is a single-group, open-label Phase I pilot in successive cohorts; participants complete the online program and assessments at baseline, after the program, and at follow-up. The study will evaluate feasibility, acceptability, adherence, and preliminary effects on psychological stress and cardiovascular health behaviors.

What it is studying. The study is testing whether the TEAM-LEADS online program is feasible to deliver and acceptable to adolescents and young adults with juvenile-onset lupus or dermatomyositis, and whether participation is associated with changes in self-reported psychological stress and a composite cardiovascular health behaviors score.

What the researchers hope to learn. Evaluate feasibility and acceptability of the online TEAM-LEADS intervention; measure adherence to the program; collect preliminary data on change in PROMIS Pediatric Psychological Stress Experiences T-scores (primary outcome, baseline to Day 84) and change in a Cardiovascular Health Behaviors Score (secondary outcome, baseline to up to Day 168).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral: TEAM-LEADS

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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

Exclusion criteria

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Patients with juvenile systemic lupus erythematosus (JSLE) and juvenile dermatomyositis (JDM) are at higher risk of cardiovascular disease, with premature mortality. Adolescents and young adults with JSLE/JDM experience high rates of psychological stress which is associated with worse cardiovascular health (CVH) behaviors, including inadequate physical activity, diet quality, and sleep. However, evidence-based behavioral interventions for stress reduction remain inaccessible for many adolescents and young adults with JSLE/JDM. There is a critical need for stress reduction interventions that are effective, accessible, and tailored to JSLE/JDM-specific experiences. 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress', or TEAM-LEADS, is an online stress reduction and CVH behavior promotion intervention for adolescents and young adults with JSLE/JDM. TEAM-LEADS will be evaluated in a Phase I open-label, single-arm successive cohort pilot trial in adolescents and young adults with JSLE and JDM. Participants will complete the online intervention and assessments at baseline, post-intervention, and follow-up. The study will evaluate feasibility, acceptability, adherence, and preliminary efficacy for stress reduction and CVH behavior promotion.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants complete the online TEAM-LEADS self-administered program and study assessments at baseline (day 0), after the intervention (post-intervention), and at follow-up (primary outcome measured by day 84 and secondary follow-up up to day 168). Assessments include patient-reported stress measures (PROMIS Pediatric Psychological Stress) and questions about diet, physical activity, and sleep to form a cardiovascular health behaviors score. Participation is carried out online and involves completing program modules and study surveys; the study will record feasibility, acceptability, adherence, and changes in stress and health behaviors.

How the study is structured. Interventional, single-group (no comparison group), open-label Phase I pilot. Participants complete a self-administered online behavioral program and complete assessments at baseline, immediately after the program (post-intervention), and at a later follow-up time point.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Lupus; Dermatomyositis, Juvenile; Dermatomyositis; Lupus Erythematosus; Lupus Erythematosus, Systemic; Lupus or SLE. Does it apply to my diagnosis?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on polymyositis

This trial is also listed on this site under dermatomyositis.

Clinical trials55 trials listed for polymyositisEvery trial the registry lists for polymyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in polymyositis researchLatest monthly update: September 2026. Includes: CD4 count risk. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Feb 1, 2027 (estimated)
Primary completion: Oct 23, 2028 (estimated)
Study completion: Jan 15, 2029 (estimated)
Target enrollment: 25 participants (estimated)
Last updated on registry: May 27, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Duke University
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Kaveh Ardalan, MD, MS 📞 919-684-6575 ✉ kaveh.ardalan@duke.edu

Participating sites (1)

Duke University Medical Center
Durham, North Carolina, 27710 · United States
- Kaveh Ardalan, MD, MS · 919-684-6575 · kaveh.ardalan@duke.edu
- Kaveh Ardalan, MD, MS

Terms used on this page · explanations by MedicalUpdates.ai

enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Phase I: An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
open-label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
single-arm: All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
cohort: A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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