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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06999109
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
13 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Feb 1, 2027
Status verified
May 2026
Primary completion
Oct 23, 2028
Completion
Jan 15, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: TEAM-LEADS intervention arm

Primary Outcome Measure

Change in Patient-Reported Outcome Measures Information System (PROMIS) Pediatric Psychological Stress Experiences (version 1.0 Short Form 8a) T-scores [ Time Frame: From T1 (baseline visit, day 0) to T3 (Day 84) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Kaveh Ardalan, MD, MS
[email protected]
919-684-6575
Kaveh Ardalan, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Duke University Medical Center· Durham, NC

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