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.

Study Overview

• Status: Not yet recruiting
• Conditions: SLE
• Intervention / Treatment: Other: The multidimensional peer victimization scale (PVS)

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 Type: Observational
• Enrollment (Estimated): 62

Contacts and Locations

• Study Contact: Name: Sahar Samir, resident; Phone Number: 01067046915; Email: samirsamar936@gmail.com
• Study Contact Backup: Name: Naglaa Samy, Associate proff; Phone Number: 01002673103; Email: Naglaaosman84@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

: this study will include patients who already diagnosed with SLE and following in allergy&immunology and rheumatology unit assiut university children hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control healthy group; is 1) no history of psychiatric and medical disease 2) Intelligence quotation more than 70.
SLE group; 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	Other: The multidimensional peer victimization scale (PVS); The multidimensional peer victimization scale (PVS), a self-report scale for children and adolescents, was used to assess the victimization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating mental health challenges in juvenile SLE and their caregivers	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.	baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Nagwa Ali, Professor of pediatric, Assiut University; Study Director: Gellan Karamallah Ramadan Ahmed, lecturer of psychiatry, Assiut University; Study Director: Naglaa Samy, Associate proff, Assiut University

Publications and helpful links

General Publications

• The American College of Rheumatology nomenclature and case definitions for neuropsychiatric lupus syndromes. Arthritis Rheum. 1999 Apr;42(4):599-608. doi: 10.1002/1529-0131(199904)42:43.0.CO;2-F.
• Sarwar S, Mohamed AS, Rogers S, Sarmast ST, Kataria S, Mohamed KH, Khalid MZ, Saeeduddin MO, Shiza ST, Ahmad S, Awais A, Singh R. Neuropsychiatric Systemic Lupus Erythematosus: A 2021 Update on Diagnosis, Management, and Current Challenges. Cureus. 2021 Sep 14;13(9):e17969. doi: 10.7759/cureus.17969. eCollection 2021 Sep.
• Ho RC, Mak A. The interface between medicine and psychiatry: neuropsychiatric aspects of systemic lupus erythematosus (SLE). Ann Acad Med Singap. 2014 Aug;43(8):388-90. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: J.SLE and psychiatry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No