Dermatomyositis, Dermatomyositis, Juvenile, Lupus, Lupus Erythematosus, Lupus Erythematosus, Systemic, Lupus or SLE
Conditions
Keywords
Stress, Depression, Anxiety, Lupus, Dermatomyositis, Pediatric Rheumatology, Physical Activity, Diet Quality, Sleep, Cardiovascular Health, Health Behaviors, Remote Intervention, Online Intervention, Co-Design, Intervention Refinement
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
Patients with juvenile systemic lupus erythematosus (JSLE) and juvenile dermatomyositis (JDM) are at higher risk of cardiovascular disease, with premature mortality. Adolescents and young adults with JSLE/JDM experience high rates of psychological stress which is associated with worse cardiovascular health (CVH) behaviors, including inadequate physical activity, diet quality, and sleep. However, evidence-based behavioral interventions for stress reduction remain inaccessible for many adolescents and young adults with JSLE/JDM. There is a critical need for stress reduction interventions that are effective, accessible, and tailored to JSLE/JDM-specific experiences. 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress', or TEAM-LEADS, is an online stress reduction and CVH behavior promotion intervention for adolescents and young adults with JSLE/JDM. TEAM-LEADS will be evaluated in a Phase I open-label, single-arm successive cohort pilot trial in adolescents and young adults with JSLE and JDM. Participants will complete the online intervention and assessments at baseline, post-intervention, and follow-up. The study will evaluate feasibility, acceptability, adherence, and preliminary efficacy for stress reduction and CVH behavior promotion.
Interventions
BEHAVIORALTEAM-LEADS
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
Sponsors
Duke University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM) * Age 13-22 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiovascular Health Behaviors Score | From T1 (baseline visit, day 0) to T3 (up to Day 168) | 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. |
Countries
United States
Contacts
CONTACTKaveh Ardalan, MD, MS
PRINCIPAL_INVESTIGATORKaveh Ardalan, MD, MS
Duke University
Outcome results
None listed