Lupus
Conditions
Brief summary
This study aims to understand how the TEACH program helps improve mental health and well-being in adolescents with childhood-onset lupus. Researchers will examine changes in brain function and inflammation before and after the program and explore how these changes relate to improvements in symptoms such as anxiety, depression, fatigue, and pain. Twenty adolescents with cSLE, aged 12-18 years, will participate by completing the TEACH program, brain imaging, blood tests, and questionnaires.
Interventions
BEHAVIORALTEACH
TEACH is a form of cognitive behavioral therapy that has been carefully adapted for adolescents with lupus. It targets common and debilitating symptoms in cSLE, including depression, fatigue, anxiety, and pain. Core components include psychoeducation, activity pacing, cognitive restructuring, relaxation and mindfulness strategies, problem solving, and caregiver-supported skill development. TEACH has previously demonstrated clinical efficacy in reducing depressive symptoms and improving fatigue and anxiety in adolescents with lupus.
Sponsors
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. be diagnosed with cSLE, meeting 2012 American College of Rheumatology (ACR)/System Lupus International Collaborating Clinics (SLICC) and/or European League Against Rheumatism (EULAR)/ACR classification criteria for SLE by age 18 years 2. be between the ages of 12 and 18 years 3. have stable disease meeting criteria for low lupus disease activity state (LLDAS) 4. in recognition of the heterogeneity of symptoms, have elevations (T scores ≥60; see Measures section) in fatigue 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) 5. have English language proficiency for cognitive assessment.
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 (T score ≥90) or active suicidal ideation (SI), based on the Children's Depression Inventory (CDI-II) /Beck Depression Inventory (BDI-II) items or PHQ9 score ≥21. 4. current psychotropic medication use 5. concurrent psychotherapy or other psychological intervention 6. conditions precluding cognitive task assessment (history of major head trauma, learning disability, alcohol/drug use within 24 hours of assessment, severe developmental problems affecting cognition, hearing loss or vision problems).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of serum brain-injury biomarkers and inflammatory cytokines | From baseline (start of TEACH) to the end of treatment at 8 weeks. | Measurement: Serum concentrations of brain-injury-related proteins (S100, serum neurofilament light chain \[sNFL\], glial fibrillary acidic protein \[GFAP\], and Tau) and inflammatory cytokines (including IFN-γ, IL-10, IL-12p70, IL-1β, IL-22, IL-4, IL-5, IL-6, IL-8, and TNF-α), measured using laboratory-based immunoassays. Whole blood RNA expression, including the interferon (IFN) gene signature, will also be assessed using RNA sequencing (RNA-seq). Unit of measure: Concentration (e.g., pg/mL) for serum proteins and cytokines; normalized gene expression levels for RNA-seq/IFN gene signature. |
| Change in brain neural function and tissue susceptibility | From baseline (start of TEACH) to the end of intervention at 8 weeks | Will look at changes in neuroimaging-derived measures of brain activity/connectivity (fMRI and OPM-MEG) and quantitative magnetic susceptibility (QSM) |
| Depression symptom severity using CDI/BDI questionnaire | Through study completion, an average of 1 year | We will use the total score on the Children's Depression Inventory 2nd Edition (CDI-2) to assess depressive symptoms for youth \<13 years, and The Beck Depression Inventory-II (BDI-II) for youth \>=13 years with higher scores indicating greater depression symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal changes in serum brain-injury biomarker concentrations | 26-week and 56-weeks from baseline | Longitudinal changes in serum brain-injury biomarker concentrations (S100, sNFL, GFAP, and Tau) measured using laboratory-based immunoassays |
| Longitudinal changes in brain function and tissue susceptibility in multimodal neuroimaging | 26-weeks and 52-weeks from baseline | Longitudinal changes in brain function and tissue susceptibility measured using fMRI, OPM-MEG, and quantitative susceptibility mapping (QSM) |
| Fatigue will be measured via the PROMIS Pediatric Fatigue Short Form questionnaire | Through study completion, an average of 1 year | PROMIS T-score, with higher scores indicating greater fatigue. |
| Anxiety symptom severity measured using the Screen for Child Anxiety Related Disorders (SCARED) questionnaire | Through study completion, an average of 1 year | Total SCARED score, with higher scores indicating greater anxiety symptom severity |
Outcome results
None listed