Status:
NOT_YET_RECRUITING
Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress
Lead Sponsor:
Duke University
Conditions:
Lupus
Dermatomyositis, Juvenile
Eligibility:
All Genders
12-22 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM)
- Age 12-22 years old at time of enrollment
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06999109
Start Date
January 1 2027
End Date
December 1 2028
Last Update
June 5 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710