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NCT Number: NCT07771088

Exploring Biological Mechanisms Underlying the TEACH Intervention for Adolescents With Lupus

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.

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Key information

Conditions

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • have English language proficiency for cognitive assessment.

Exclusion criteria

  • 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
  • concurrent psychotherapy or other psychological intervention
  • 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).

Treatment and study plan

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.

Primary outcomes

  1. Concentration of serum brain-injury biomarkers and inflammatory cytokines

    Time frame: 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.

  2. Change in brain neural function and tissue susceptibility

    Time frame: 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)

  3. Depression symptom severity using CDI/BDI questionnaire

    Time frame: 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 outcomes

  1. Longitudinal changes in serum brain-injury biomarker concentrations

    Time frame: 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

  2. Longitudinal changes in brain function and tissue susceptibility in multimodal neuroimaging

    Time frame: 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)

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

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

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

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

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

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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