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Not Yet Recruiting NCT05693571

Engagement and Depression in CHildhood-Onset Systemic Lupus

Conditions: Lupus Erythematosus, Systemic, Depression

Sex: All
Ages: 15 Years – 24 Years
Phase: NA
Enrollment: 40
Sponsor: Montefiore Medical Center

Summary

The goal of this observational and pilot study is to better understand how depression symptoms may contribute to how well adolescent and young adults with lupus follow-up with their lupus clinical care. The main questions it aims to answer are:Whether anhedonia (a core symptom of depression) predicts disengagement in careWhether a patient-tailored mobile health application built to improve both engagement in care and depression symptoms will be feasible and acceptable to adolescents and young adults with lupus.Participants with systemic lupus, ages 15-24 from the Bronx, New York will be asked to complete questionnaires; some will be asked to participate in focus groups to help adapt the mobile health app; participants will also be invited to join a pilot study to try the mobile health app for 6 months and answer questionnaires to document the experience.

Eligibility Criteria

Inclusion Criteria:Participants 15-24 years old meeting American College of Rheumatology (ACR) Revised SLE Classification Criteria and/or European League Against Rheumatism/ACR Classification Criteria and/or 2012 SLE International Collaborating Clinic Criteria and followed at the Children's Hospital at Montefiore.Must be diagnosed with SLE before 19 years of age (based on Childhood-onset systemic lupus erythematosus (cSLE) definition)Exclusion Criteria:Non-Spanish or non-English speakingParticipants anticipating transitioning to an outside rheumatologist for lupus care within the period of study follow-upCurrent psychotic disorders. However, attention-deficit/hyperactivity disorder, anxiety disorders, obsessive-compulsive disorder, posttraumatic stress disorder, eating disorders, and substance abuse disorders are not uncommon among adolescents and young adults (AYA) and will be allowed. Suicidal ideations (SI) and self-injurious acts (cutting) are common in depression and will be allowed (defined as passive SI).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05693571). StuddyBuddy aggregates publicly available trial information.