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NCT Number: NCT06999109

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

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.

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Key information

Age range

13 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location contact

Kaveh Ardalan, MD, MS

CONTACT

[email protected]

919-684-6575

Kaveh Ardalan, MD, MS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEAM-LEADS

Behavioral

TEAM-LEADS will be an online, self-administered intervention for stress reduction and cardiovascular health behavior promotion in adolescents and young adults with juvenile-onset systemic lupus erythematosus and dermatomyositis

Primary outcomes

  1. Change in Patient-Reported Outcome Measures Information System (PROMIS) Pediatric Psychological Stress Experiences (version 1.0 Short Form 8a) T-scores

    Time frame: From 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).

Secondary outcomes

  1. Change in Cardiovascular Health Behaviors Score

    Time frame: From T1 (baseline visit, day 0) to T3 (up to Day 168)

    Cardiovascular Health Behaviors Score is a composite of individual measures of diet quality, physical activity, and sleep duration. Scores range 0 to 100. Higher scores indicate better outcomes (i.e., greater presence of cardiovascular health behaviors) with scores = 100 indicating ideal diet quality, physical activity, and sleep duration.

Study contacts

Contact information is provided by the study sponsor or research team.

Kaveh Ardalan, MD, MS

CONTACT

[email protected]

919-684-6575

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Acronym: TEAM-LEADS

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
May 31, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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