LupusTEAM-LEADSNCT06999109
Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress
A study testing TEAM-LEADS in people with Lupus and Dermatomyositis, Juvenile, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 22 years
- Conditions the study is for
- Lupus, Dermatomyositis, Juvenile, Dermatomyositis
- What is being tested?
- TEAM-LEADS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 15 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM)
- Age 13-22 years old at time of enrollment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
Kaveh Ardalan, MD, MS, 919-684-6575, kaveh.ardalan@duke.edu
Kaveh Ardalan, MD, MS
About this study
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.
Read the 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.
- Conditions
- Lupus, Dermatomyositis, Juvenile, Dermatomyositis, Lupus Erythematosus, Lupus Erythematosus, Systemic, Lupus or SLE
- Being tested
- TEAM-LEADS
- 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
- Medical subject headings
- Dermatomyositis, Lupus Erythematosus, Systemic, Depression, Anxiety Disorders, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAM-LEADSBehavioural
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 group | Role | What they receive |
|---|---|---|
| TEAM-LEADS intervention arm | Experimental | Not described Receives: Behavioral: TEAM-LEADS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From T1 (baseline visit, day 0) to T3 (up to Day 168)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Feb 2027 (estimated)
- Primary completion23 Oct 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LupusStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Kaveh Ardalan, MD, MS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999109
- Sponsor's protocol ID
- Pro00118057
- Other IDs
- K23AR084475
- Acronym
- TEAM-LEADS
- Status last verified
- May 2026
- First submitted
- 22 May 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocols, data collection instruments, data dictionaries, and statistical analysis plans will be deposited in Vivli repository via Duke University's institutional license.
Publications
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.
PubMed 34798945
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress
- ClinicalTrials.gov ID
- NCT06999109
- Acronym / sponsor ID
- TEAM-LEADS / Pro00118057
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 23 Oct 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEAM-LEADS intervention arm | Experimental | Behavioral: TEAM-LEADS |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM)
- Age 13-22 years old at time of enrollment
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEAM-LEADSTEAM-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 | Behavioural | TEAM-LEADS intervention arm |
Primary outcome
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)
T-scores range from 37 to 81.8. Higher T-scores indicate greater psychological stress (i.e. worse outcome).
1 secondary outcome
Change in Cardiovascular Health Behaviors Score
Time frame: From T1 (baseline visit, day 0) to T3 (up to Day 168)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 34798945Ardalan 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.
- Individual participant dataSharing planned: Yes. Study protocols, data collection instruments, data dictionaries, and statistical analysis plans will be deposited in Vivli repository via Duke University's institutional license.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaveh Ardalan, MD, MS principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAM-LEADS in people with Lupus and Dermatomyositis, Juvenile, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaveh Ardalan, MD, MS (919-684-6575, kaveh.ardalan@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06999109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.