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

NCT06999109 | Not Yet Recruiting

• 1 other identifier: Pro00118057
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

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).

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

Secondary Outcomes (1)

• Change in Cardiovascular Health Behaviors Score

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

Study Arms (1)

TEAM-LEADS intervention arm

EXPERIMENTAL

Behavioral: TEAM-LEADS

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

TEAM-LEADS intervention arm

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM)
• Age 12-22 years old at time of enrollment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Ardalan K, Lloyd-Jones DM, Schanberg LE. Cardiovascular Health in Pediatric Rheumatologic Diseases. Rheum Dis Clin North Am. 2022 Feb;48(1):157-181. doi: 10.1016/j.rdc.2021.09.006. Epub 2021 Oct 29.

  PMID: 34798945 BACKGROUND

MeSH Terms

Conditions

Dermatomyositis; Lupus Erythematosus, Systemic; Depression; Anxiety Disorders; Motor Activity; Health Behavior

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Kaveh Ardalan, MD, MS

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaveh Ardalan, MD, MS

CONTACT

919-684-6575; kaveh.ardalan@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available at time of publication or the end of the performance period (whichever comes first). At a minimum, Vivli will make data available for researchers for 10 years, unless they are contractually unable to do so.
• Access Criteria: Vivli provide metadata, persistent identifiers (e.g. NCT ID), study search functions, and long-term access. Vivli repository is available to Duke investigators via institutional license and datasets are available via standardized process in which requestors search Vivli platform for the study, request the IPD data package (with requests reviewed per contributor's publicly stated requirements), and then access data in Vivli's secure environment (or download with permission).

Locations

US (1)