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

Not Applicable

Not yet recruiting

• Conditions: Lupus; Dermatomyositis, Juvenile; Dermatomyositis; Lupus Erythematosus; Lupus Erythematosus, Systemic; Lupus or SLE

• Registration Number: NCT06999109
• Lead Sponsor: Duke University

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Study First Posted: 2025-05-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Study Start: 2027-01
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcome Measures Information System (PROMIS) Pediatric Psychological Stress Experiences (version 1.0 Short Form 8a) T-scores	From T1 (baseline visit, day 0) to T3 (Day 84)	T-scores range from 37 to 81.8. Higher T-scores indicate greater psychological stress (i.e. worse outcome).

Secondary Outcome Measures

Name	Time	Method
Change in Cardiovascular Health Behaviors Score	From T1 (baseline visit, day 0) to T3 (Day 84)	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States