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Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

RECRUITING

This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.

I'm interested

ALL
12 years to 22 years old
This study is NOT accepting healthy volunteers

Inclusion Criteria:

  • 1) be diagnosed with cSLE, meeting the revised American College of Rheumatology Classification Criteria for SLE by age 18 years
  • 2) be between the ages of 12 and 22 years
  • 3) in recognition of the heterogeneity of cSLE symptoms, have elevations in fatigue (i.e., T scores ≥60; or at least moderate symptoms, on the PROMIS measure) OR depressive symptoms (≥5 on the PHQ-9, T Score ≥ 60 on the BDI or CDI II ), OR pain (i.e., average pain ≥3 out of 10 on the Pain VAS)
  • 4) have English language proficiency (their primary caregiver can have English or Spanish language proficiency for the child to enroll)
  • 5) those under age 18 years (US), or 16 years (Canada) must have a consenting caregiver

Exclusion Criteria:

  • 1) other chronic medical conditions (e.g., juvenile arthritis)
  • 2) a documented developmental delay, severe cognitive impairment, or thought disorder
  • 3) an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression (PHQ9 score ≥21, BDI/CDI II > 90) or active suicidal ideation (SI), based on the Pediatric Health Questionnaire (PHQ-9) items plus clinical interview; see Measures section)

BEHAVIORAL: TEACH

Systemic Lupus Erythematosus of Childhood (Disorder)

lupus, depression, depressive symptoms, fatigue, pain, SLE, rheumatic disease, rheumatology, cognitive behavioral, Childhood-onset Systemic Lupus Erythematosus, cSLE, Implementation, Coping skills, Mindfulness

Jainish Patel - jainish.patel@cchmc.org
NA
NCT06232304
See this study on ClinicalTrials.gov

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