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Search / Trial NCT06999109

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

Launched by DUKE UNIVERSITY · May 22, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Stress Depression Anxiety Lupus Dermatomyositis Pediatric Rheumatology Physical Activity Diet Quality Sleep Cardiovascular Health Health Behaviors Remote Intervention Online Intervention Co Design Intervention Refinement

ClinConnect Summary

This clinical trial, called Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress (TEAM-LEADS), is looking to see if a special program can help young people with lupus and dermatomyositis manage stress and improve their heart health. The study will involve teenagers and young adults aged 12 to 22 who have been diagnosed with juvenile-onset systemic lupus erythematosus or dermatomyositis. The goal is to find out if this program is easy to use and if the participants find it helpful.

To join the study, participants need to have a diagnosis of juvenile lupus or dermatomyositis and be between 12 and 22 years old. Unfortunately, those who have severe emotional distress or cannot access the internet for surveys and interviews won’t be able to participate. Those who do take part can expect to engage in activities designed to lower stress and promote healthier lifestyle choices. This study has not started recruiting participants yet, but it aims to provide valuable insights into the mental health needs of young people living with these conditions.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM)
  • Age 12-22 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.

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Kaveh Ardalan, MD, MS

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported