Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Systemic Lupus Erythematosus Patients

NCT05971498 | Unknown

• 1 other identifier: AssiutU SLE
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this case control observational study is to asses anxiety, sleep, depression and quality of life in Systemic Lupus Erythematosus (SLE) patients. The main aims are:

• asses anxiety, sleep, depression and quality of life in SLE patients
• their relation to disease activity we will compare SLE patients to healthy subjects.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (6)

• Evaluation of insomnia in SLE patients by Insomnia severity index

  insomnia severity index contains seven domains assessing sleep-onset difficulties, sleep maintenance, sleep satisfaction, effect on daily functioning, impairment attributed to sleep problems, and distress associated with insomnia. Each item is rated on a 0-4 scale, and th e total score ranges from 0 to 28. A higher score suggests more severe insomnia

  3 MONTHS

• evaluation of excessive daytime sleepiness in SLE patients by Epworth sleepiness scale

  Subjects describe how often they fall asleep in certain situations on a scale of 0-3, with total scores ranging from 0 to 24. An ESS score ≥ 10 is indicative of subjective excessive daytime sleepiness and score \> 16 indicates high level of daytime sleepiness

  3 months

• evaluation of anxiety in SLE patients by hamilton anxiety rating scale

  It consists of 14 items and measures both psychic and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where a score ≤ 17 indicates mild anxiety, 18-24 mild to moderate anxiety, , 25-30 moderate to severe anxiety and scores \>30 indicate severe anxiety

  3 months

• evaluation of depression in SLE patients by hamilton depression rating scale

  The original scale has 21 items, but scoring is based only on the first 17 with total score ranges from 0 to 52. Scores less than or equal to 7 indicates normal response, 8-13 mild depression, 14-18 Moderate, 19-22 severe, and \> 22 very severe depression.

  3 months

• evaluation of QoL in SLE patients by short form health survey (sf36 )

  Thirty-five of the 36 items are grouped into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. One item assesses perception of changes in health over the last year but is not used calculate scale scores. Mean score ranges from 0 to100. High scores indicate lower disability

  3 months

• evaluation of sleep quality and disturbances in SLE patients by Pittsburgh Sleep Quality Index

  The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). The scores for each component are summed to get a total score (range 0-21). A score \> 5 suggests poor sleep quality

  3 months

Secondary Outcomes (1)

• Correlation of disease activity (SLEDAI) with Hamilton anxiety rating scale, Hamilton depression rating scale, Epworth sleepiness scale,Pittsburgh Sleep Quality Index and short form health survey sf 36

  3 months

Study Arms (2)

cases

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

SLE patients and healthy control

You may qualify if:

• Patients diagnosed with SLE according to the 2012 systemic lupus international collaborating clinics (SLICC) criteria .

You may not qualify if:

• Evidence of end-organ failures such as heart failure, liver cell or renal failure,
• History of psychological disorders .

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine, Assiut university hospital

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Maha Abdelrahman, MD,PhD

CONTACT

+201011212050; mahasayed@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: August 14, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

EG (1)