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

NCT ID: NCT05957770

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-10-30

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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

cases

rheumatoid arthritis patients

No interventions assigned to this group

control

healthy subjects

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Maha Sayed Ibrahim Abdelrahman

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha Abdelrahman, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Faculty of medicine, Assiut university hospital

Asyut, , Egypt

Countries

Egypt

Other Identifiers

04-2023-300223

Identifier Type: -

Identifier Source: org_study_id