Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress (TEAM-LEADS)

Duke University

Status: Begins enrollment in 10 months

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

Treatments: Behavioral: TEAM-LEADS

Study type: Interventional

Funder types: Other

Identifiers

NCT06999109

Pro00118057

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 12 to 22 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

TEAM-LEADS intervention arm

Experimental group

Treatment:

Behavioral: TEAM-LEADS