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

N/ANot Yet RecruitingNCT06999109

Duke University25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Lupus Dermatomyositis, Juvenile Dermatomyositis Lupus Erythematosus Lupus Erythematosus, Systemic Lupus or SLE

Interventions

TEAM-LEADSBEHAVIORAL

TEAM-LEADS will be an online, self-administered intervention for stress reduction and cardiovascular health behavior promotion in adolescents and young adults with juvenile-onset systemic lupus erythematosus and dermatomyositis

Eligibility

Sex: ALLMin age: 12 YearsMax age: 22 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Patient-Reported Outcome Measures Information System (PROMIS) Pediatric Psychological Stress Experiences (version 1.0 Short Form 8a) T-scores

T-scores range from 37 to 81.8. Higher T-scores indicate greater psychological stress (i.e. worse outcome).

Time frame: From T1 (baseline visit, day 0) to T3 (Day 84)

Secondary Outcomes

Change in Cardiovascular Health Behaviors Score

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.