Exploring Biological Mechanisms Underlying the TEACH Intervention for Adolescents With Lupus

ConditionLupus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorThe Hospital for Sick Children

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

be between the ages of 12 and 18 years

have stable disease meeting criteria for low lupus disease activity state (LLDAS)

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)

Disqualifiers

other chronic medical conditions (e.g., juvenile arthritis)

a documented developmental delay, severe cognitive impairment, or thought disorder

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.

current psychotropic medication use

Trial design

Design model

Single group

Treatments tested in this trial

  • TEACH

    Behavioral

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: TEACHExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Concentration of serum brain-injury biomarkers and inflammatory cytokines

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.

Time frame
From baseline (start of TEACH) to the end of treatment at 8 weeks.
2

Change in brain neural function and tissue susceptibility

Will look at changes in neuroimaging-derived measures of brain activity/connectivity (fMRI and OPM-MEG) and quantitative magnetic susceptibility (QSM)

Time frame
From baseline (start of TEACH) to the end of intervention at 8 weeks
3

Depression symptom severity using CDI/BDI questionnaire

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.

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Longitudinal changes in serum brain-injury biomarker concentrations

Longitudinal changes in serum brain-injury biomarker concentrations (S100, sNFL, GFAP, and Tau) measured using laboratory-based immunoassays

Time frame
26-week and 56-weeks from baseline
2

Longitudinal changes in brain function and tissue susceptibility in multimodal neuroimaging

Longitudinal changes in brain function and tissue susceptibility measured using fMRI, OPM-MEG, and quantitative susceptibility mapping (QSM)

Time frame
26-weeks and 52-weeks from baseline
3

Fatigue will be measured via the PROMIS Pediatric Fatigue Short Form questionnaire

PROMIS T-score, with higher scores indicating greater fatigue.

Time frame
Through study completion, an average of 1 year
4

Anxiety symptom severity measured using the Screen for Child Anxiety Related Disorders (SCARED) questionnaire

Total SCARED score, with higher scores indicating greater anxiety symptom severity

Time frame
Through study completion, an average of 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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