About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM)
Age 13-22 years old at time of enrollment
Disqualifiers
Inability to complete surveys/interviews reliably
Lack of access to internet-enabled device;
Non-JSLE/JDM diagnosis
History of myocardial infarction or cerebrovascular accident
Trial design
Single group
Treatments tested in this trial
TEAM-LEADS
BehavioralTEAM-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
Treatment groups
Trial outcomes
Primary outcomes
Change in Patient-Reported Outcome Measures Information System (PROMIS) Pediatric Psychological Stress Experiences (version 1.0 Short Form 8a) T-scores
T-scores range from 37 to 81.8. Higher T-scores indicate greater psychological stress (i.e. worse outcome).
Secondary outcomes
Change in Cardiovascular Health Behaviors Score
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.
Sponsors and contacts
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Duke University
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
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