Clinical trial NCT05957770: Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Rheumatoid Arthritis Patients
Official title: Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 60
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: Patients diagnosed with RA according to 2010 the American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria.

Healthy subjects

Brief summary: The goal of this case control observational study is to asses anxiety, sleep, depression and quality of life in rheumatoid arthritis patients

The main aims are:

* asses anxiety, sleep, depression and quality of life in rheumatoid arthritis patients
* their relation to disease activity

we will compare rheumatoid arthritis patients to healthy subjects.

Detailed description: All patients were subjected to clinical evaluation (full history and examination, laboratory evaluation (erythrocyte sedimentation rate \[ESR\], C reactive protein \[CRP\] and rheumatoid factor \[RF\]), in addition to assessment of disease activity (disease activity score in 28 joints \[DAS28\]-ESR

Psychological assessment was 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 RA according to 2010 the American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria

Exclusion Criteria:

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

Primary outcomes:
measure: Evaluation of insomnia in RA patients by Insomnia severity index
timeFrame: 1 month
measure: evaluation of excessive daytime sleepiness by Epworth sleepiness scale
timeFrame: 1 month
measure: evaluation of anxiety in RA patients by hamilton anxiety scale
timeFrame: 1 month
measure: evaluation of depression in RA patients by hamilton depression scale
timeFrame: 1 month
measure: evaluation of QoL in RA patients by short form health survey (sf36 )
timeFrame: 1 month
measure: evaluation of sleep quality and disturbances in RA patients by Pittsburgh Sleep Quality Index
timeFrame: 1 month
Secondary outcomes:
measure: Correlation of disease activity( das28) with hamilton anxiety scale, hamilton depression scale,Epworth sleepiness scale,Pittsburgh Sleep Quality Index and short form health survey sf 36
timeFrame: 1 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine, Assiut university hospital
Study officials:
affiliation: Assiut University
name: Maha Abdelrahman, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: