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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-22
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM)

Age 13-22 years old at time of enrollment

Disqualifiers

Inability to complete surveys/interviews reliably

Lack of access to internet-enabled device;

Non-JSLE/JDM diagnosis

History of myocardial infarction or cerebrovascular accident

Trial design

Design model

Single group

Treatments tested in this trial

  • TEAM-LEADS

    Behavioral

    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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: TEAM-LEADS intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.

Time frame
From T1 (baseline visit, day 0) to T3 (up to Day 168)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: