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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
13 Years to 22 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether TEAM-LEADS, a mental health program, is practical and well accepted by teens and young adults with lupus or dermatomyositis. It also looks at whether the program can lower stress and support heart-healthy habits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have lupus that started in childhood, a disease where the immune system attacks the body, or juvenile dermatomyositis, a disease that causes muscle swelling and skin rash.
  • Be 13 to 22 years old when joining the study.

Who can't join

  • Cannot reliably complete surveys or interviews.
  • Do not have access to a device that connects to the internet.
  • Do not have childhood-onset lupus or juvenile dermatomyositis.
  • Have had a heart attack or stroke.
  • Have a score of 15 or higher on the PHQ9A depression survey at screening.
  • Report any thoughts of suicide on the PHQ9A survey at screening.
  • Show other signs of severe emotional distress at screening, as judged by the lead researcher.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NC