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

• ClinicalTrials.gov Identifier: NCT05957770
• Recruitment Status: Completed
• First Posted: July 24, 2023
• Last Update Posted: November 7, 2023
• Sponsor: Assiut University
• Information provided by (Responsible Party): Maha Sayed Ibrahim Abdelrahman, Assiut University

Study Description

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.

Condition or disease
Rheumatoid Arthritis

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 Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Rheumatoid Arthritis Patients
• Actual Study Start Date: February 1, 2023
• Actual Primary Completion Date: October 15, 2023
• Actual Study Completion Date: October 30, 2023

Groups and Cohorts

Group/Cohort
cases; rheumatoid arthritis patients
control; healthy subjects

Outcome Measures

Primary Outcome Measures :

1. Evaluation of insomnia in RA patients by Insomnia severity index [ Time Frame: 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

2. evaluation of excessive daytime sleepiness by Epworth sleepiness scale [ Time Frame: 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
3. evaluation of anxiety in RA patients by hamilton anxiety scale [ Time Frame: 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
4. evaluation of depression in RA patients by hamilton depression scale [ Time Frame: 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
5. evaluation of QoL in RA patients by short form health survey (sf36 ) [ Time Frame: 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.
6. evaluation of sleep quality and disturbances in RA patients by Pittsburgh Sleep Quality Index [ Time Frame: 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

Secondary Outcome Measures :

1. 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 [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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

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.

Contacts and Locations

Locations

Egypt

Faculty of medicine, Assiut university hospital

Assiut, Egypt, 71515

Sponsors and Collaborators

Assiut University

Investigators

• Principal Investigator: Maha Abdelrahman, MD,PhD; Assiut University

More Information

• Responsible Party: Maha Sayed Ibrahim Abdelrahman, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05957770
• Other Study ID Numbers: 04-2023-300223
• First Posted: July 24, 2023
• Last Update Posted: November 7, 2023
• Last Verified: November 2023

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases