Evaluating Mental Health Challenges in Juvenile Lupus Erythematosus and Their Caregivers

Not yet recruiting

• Conditions: SLE
• Interventions: Other: The multidimensional peer victimization scale (PVS)

• Registration Number: NCT06581029
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-08-29
• Study First Posted: 2024-08-30
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Study Start: 2025-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Age from 11 to 18 years
2. Both sex
3. diagnosed with SLE for at least 6 months to allow for an adjustment period following diagnosis.
4. 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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SLE group	The multidimensional peer victimization scale (PVS)	I. Age from 11 to 18 years II. Both sex III. diagnosed with SLE for at least 6 months to allow for an adjustment period following diagnosis. use of The multidimensional peer victimization scale (PVS), a self-report scale for children and adolescents, was used to assess the victimization

Primary Outcome Measures

Name	Time	Method
Evaluating mental health challenges in juvenile SLE and their caregivers	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.