Clinical trial NCT05971498: Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Systemic Lupus Erythematosus Patients
Official title: Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Systemic Lupus Erythematosus Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: SLE patients and healthy control

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.

Detailed description: All patients will be subjected to clinical evaluation (full history and examination, laboratory evaluation (include erythrocyte sedimentation rate (ESR) measured by standard westergren method (mm/h), serum C-reactive protein (CRP), complete blood count (CBC), serum urea and creatinine, aspartate transaminase (AST), alanine transaminase (ALT), complete urine analysis for: urinary casts (hyaline, granular), hematuria (RBCs/ high power field), pyuria (WBCs/ high power field), 24-hour urinary protein and creatinine clearance. Immunological work up will include antinuclear antibodies (ANA) by ELISA, anti-double stranded DNA (ds-DNA) by ELISA and complement components C3 and C4 by nephelometry. Disease activity will be assessed via SLE disease activity index (SLEDAI): SLEDAI is based on the presence of 24 descriptors in nine organ systems over the preceding 30 days. Descriptors of SLEDAI are documented as present or absent. Each of the descriptors has a weighted score and the total score of SLEDAI is the sum of all 24 descriptor scores. The total score falls between 0 and 105, with higher scores representing higher disease activity.

Psychological assessment will be performed according to the following scales

* Hamilton Anxiety Rating Scale (HAM-A): 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.
* Hamilton Depression Rating Scale: the original scale has 21 items, but scoring is based only on the first 17. 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.

Sleep quality assessment was done via

* Insomnia severity index (ISI) : 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 the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
* 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.

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.

Assessment of Health status and quality of life via 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. Higher scores indicate high quality of life.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Evaluation of insomnia in SLE patients by Insomnia severity index
timeFrame: 3 MONTHS
measure: evaluation of excessive daytime sleepiness in SLE patients by Epworth sleepiness scale
timeFrame: 3 months
measure: evaluation of anxiety in SLE patients by hamilton anxiety rating scale
timeFrame: 3 months
measure: evaluation of depression in SLE patients by hamilton depression rating scale
timeFrame: 3 months
measure: evaluation of QoL in SLE patients by short form health survey (sf36 )
timeFrame: 3 months
measure: evaluation of sleep quality and disturbances in SLE patients by Pittsburgh Sleep Quality Index
timeFrame: 3 months
Secondary outcomes:
measure: 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
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine, Assiut university hospital
Study officials:
References: