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Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress | Clinical Trials | Clareo Health

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

NCT06999109•Duke University

View on ClinicalTrials.gov

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 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

Age

12 - 22 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Key Dates

Start Date

January 1, 2027

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2028

Last Updated

June 5, 2025

Enrollment

ESTIMATED participants

Conditions

LupusDermatomyositis, JuvenileDermatomyositisLupus ErythematosusLupus Erythematosus, SystemicLupus or SLE

Interventions

TEAM-LEADS

BEHAVIORAL

Contacts

Kaveh Ardalan, MD, MS

CONTACT

919-684-6575 kaveh.ardalan@duke.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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