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NCT Number: NCT06581029

Evaluating Mental Health Challenges in Juvenile Lupus Erythematosus and Their Caregivers

assessment of psychiatric problems in pediatric SLE and their caregivers. evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life.

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Key information

Conditions

SLE

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

Juvenile-onset systemic lupus erythematosus (jSLE) is a rare but severe multisystem autoimmune disease which may cause significant damage, disability, and death . Juvenile SLE patients constitute 15-20% of all SLE cases . Compared to the adult SLE, jSLE patients have higher morbidity and mortality rates. Renal, cardiovascular, and neuropsychiatric (NP) involvements are the most important reasons for morbidity and mortality .

Therefore, knowledge of common mental illnesses such as major depressive disorder (MDD) and anxiety disorders in cSLE may be limited. Establishing the prevalence of MDD and anxiety in cSLE is important , as comorbidity rates of these disorders may be increased in cSLE for several reasons. First, the diagnosis of a serious physical health condition confers psychological vulnerability to feelings of sadness, helplessness, stress, and worry about the future.9 For some individuals, such symptoms warrant further evaluation and may persist beyond the initial adjustment period and reach clinical significance, requiring therapeutic intervention. SLE carries a patient-treatment burden similar to other chronic diseases. Such treatment burden places susceptible individuals at risk of psychiatric disorder. Second, although depressed mood may present in the absence of active CNS disease, it may also occur as a symptom of neuropsychiatric c SLE (NPSLE), yielding clinically significant treatment implications. Third, treatment of SLE with known depressogenic medications like steroid may lead to depressive symptom elevation or exacerbate a co-morbid primary MDD. Moreover, among patients with depressed mood as a manifestation of NPSLE, the initiation of steroid treatment may worsen depressive symptoms. It is unclear whether such risks are observed in the cSLE population.

Who can participate

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

Inclusion criteria

  • Age from 11 to 18 years
  • Both sex
  • diagnosed with SLE for at least 6 months to allow for an adjustment period following diagnosis.
  • Met the New ACR and EULAR criteria for classification of SLE .

Inclusion criteria

of the control healthy group : 1- no history of psychiatric and medical disease 2-Intelligence quotation more than 70.

Exclusion criteria

  • No history of psychiatric illness prior to the diagnosis of lupus.
  • Intelligence quotation more than 70.

Treatment and study plan

The multidimensional peer victimization scale (PVS)

Other

The multidimensional peer victimization scale (PVS), a self-report scale for children and adolescents, was used to assess the victimization

Primary outcomes

  1. Evaluating mental health challenges in juvenile SLE and their caregivers

    Time frame: baseline

    The aim of the present study is to evaluate and assess psychiatric problems in juvenile systemic lupus erythematosus patients and their caregivers. Also, to evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Naglaa Samy, Associate proff

CONTACT

[email protected]

01002673103

Sahar Samir, resident

CONTACT

[email protected]

01067046915

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Feb 4, 2025

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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