Duke University Medical Center
Durham, North Carolina, 27710, United States
Location contact
Kaveh Ardalan, MD, MS
CONTACT
Kaveh Ardalan, MD, MS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06999109
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.
Trial opening soon.
Get Notified13 year–22 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Kaveh Ardalan, MD, MS
CONTACT
Kaveh Ardalan, MD, MS
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Duke University
Other
Acronym: TEAM-LEADS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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