Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Rheumatoid Arthritis Patients

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT05957770
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-24
• Primary Completion: 2023-10-15
• Study Completion: 2023-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-04
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of insomnia in RA patients by Insomnia severity index	1 month	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
evaluation of excessive daytime sleepiness by Epworth sleepiness scale	1 month	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
evaluation of sleep quality and disturbances in RA patients by Pittsburgh Sleep Quality Index	1 month	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
evaluation of anxiety in RA patients by hamilton anxiety scale	1 month	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
evaluation of depression in RA patients by hamilton depression scale	1 month	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
evaluation of QoL in RA patients by short form health survey (sf36 )	1 month	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.

Secondary Outcome Measures

Name	Time	Method
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	1 month	The DAS28 assessment includes a measurement of tender joint count (TJC), swollen joint count (SJC) acute phase reactant (ESR or CRP) and patient's global assessment of disease activity, which is scored from zero to 100 with higher scores indicating active disease. DAS28\>5.1 indicates high disease activity. A score 3.5-5.1 indicates moderate disease activity. A score 2.6-3.2 indicates low disease activity and score \<2.6 indicates remission. Score ranges from 0 to 9.4

Trial Locations

Locations (1)

Faculty of medicine, Assiut university hospital; 🇪🇬 Assiut, Egypt