Alexithymia in Ankylosing Spondylitis

The study included 55 patients having Ankylosing Spondylitis (AS) for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects. Demographic data were recorded for 55 AS patients who were subsequently assessed using the BASMI (Bath Ankylosing Spondylitis Metrology Index) in terms of elasticity and spinal mobility as well as the BASFI (Bath Ankylosing Spondylitis Functional Index) to determine functional status, the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) to assess the disease activity and the ASQoL (Ankylosing Spondylitis Quality of Life Questionnaire) to evaluate quality of life. The Toronto Alexithymia Scale-20 (TAS-20) was used for assessment of alexithymia and Beck's Depression Inventory (BDI) for depression among patients.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Diagnostic test: Bath Ankylosing Spondylitis Metrology Index (BASMI); Diagnostic test: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); Diagnostic test: Bath Ankylosing Spondylitis Functional Index (BASFI); Diagnostic test: Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL); Diagnostic test: Toronto Alexithymia Scale-20 (TAS-20); Diagnostic test: Beck's Depression Inventory (BDI)

Detailed Description

The study included 55 patients having Ankylosing Spondylitis (AS) for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects. Demographic data were recorded for 55 AS patients who were subsequently assessed using the BASMI (Bath Ankylosing Spondylitis Metrology Index) in terms of elasticity and spinal mobility as well as the BASFI (Bath Ankylosing Spondylitis Functional Index) to determine functional status, the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) to assess the disease activity and the ASQoL (Ankylosing Spondylitis Quality of Life Questionnaire) to evaluate quality of life. The Toronto Alexithymia Scale-20 (TAS-20) was used for assessment of alexithymia and Beck's Depression Inventory (BDI) for depression among patients.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34732
    • Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study included 55 patients having AS for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects.

Description

Inclusion Criteria:

• Diagnosed as AS for at least 1 year according to the ASAS classification criteria
• over 18 years old

Exclusion Criteria:

• fibromyalgia
• age less than 18 years
• vision and hearing impairment
• neurological disease (Parkinson's disease, multiple sclerosis, cerebrovascular disease),
• history of a psychiatric disorder (schizophrenia, bipolar disorder)
• history of chronic condition (DM, thyroid disease) or malignancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ankylosing spondylitis; 55 patients having Ankylosing Spondylitis (AS) for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic	Diagnostic test: Bath Ankylosing Spondylitis Metrology Index (BASMI); It characterises the spinal mobility of patients with ankylosing spondylitis. Cervical rotation, tragus-wall distance, lateral lumbar flexion, anterior lumbar flexion (modified schober), intermalleolar distance were measured. The total score of the 5 measurements was taken, the score range was 0-10, the low score meant that the spinal movement was better.; Diagnostic test: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); It assess the disease activity. It was evaluated with a 6-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.; Diagnostic test: Bath Ankylosing Spondylitis Functional Index (BASFI); It assess functional status. It was evaluated with a 10-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.; Diagnostic test: Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL); It evaluates quality of life. Each statement on the ASQoL (18-item) is given a score of "1" or "0". A score of "1" is given where the item is affirmed, indicating adverse QoL. All item scores are summed to give a total score or index. Scores can range from 0 (good QoL) to 18 (poor QoL).; Diagnostic test: Toronto Alexithymia Scale-20 (TAS-20); It assess alexithymia. It is a 20 item questionnaire and each item is evaluated in a Likert type scale with five intervals (1= strongly disagree, 5=strongly agree). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.; Diagnostic test: Beck's Depression Inventory (BDI); It assess depression status. It is a 21-question multiple-choice self-report inventory, each set is ranked in terms of severity and scored from 0 to 3 with a total summed score range of 0-63. Higher scores indicate greater depressive severity. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.
healthy control; age and sex matched healthy controls	Diagnostic test: Bath Ankylosing Spondylitis Metrology Index (BASMI); It characterises the spinal mobility of patients with ankylosing spondylitis. Cervical rotation, tragus-wall distance, lateral lumbar flexion, anterior lumbar flexion (modified schober), intermalleolar distance were measured. The total score of the 5 measurements was taken, the score range was 0-10, the low score meant that the spinal movement was better.; Diagnostic test: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); It assess the disease activity. It was evaluated with a 6-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.; Diagnostic test: Bath Ankylosing Spondylitis Functional Index (BASFI); It assess functional status. It was evaluated with a 10-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.; Diagnostic test: Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL); It evaluates quality of life. Each statement on the ASQoL (18-item) is given a score of "1" or "0". A score of "1" is given where the item is affirmed, indicating adverse QoL. All item scores are summed to give a total score or index. Scores can range from 0 (good QoL) to 18 (poor QoL).; Diagnostic test: Toronto Alexithymia Scale-20 (TAS-20); It assess alexithymia. It is a 20 item questionnaire and each item is evaluated in a Likert type scale with five intervals (1= strongly disagree, 5=strongly agree). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.; Diagnostic test: Beck's Depression Inventory (BDI); It assess depression status. It is a 21-question multiple-choice self-report inventory, each set is ranked in terms of severity and scored from 0 to 3 with a total summed score range of 0-63. Higher scores indicate greater depressive severity. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Alexithymia rate in AS patients and controls according to Toronto Alexithymia Scale-20	7 months
Depression rate in AS patients and controls according to Beck Depression Inventory	7 months
Relationship between alexithymia and depression and functional indexes (BASFI, BASMI, BASDAI, ASQoL)	7 months

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 15, 2016

Study Registration Dates

• First Submitted: March 22, 2020
• First Submitted That Met QC Criteria: March 22, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 22, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: ankylosing spondylitis; alexithymia
• Additional Relevant MeSH Terms: Behavioral Symptoms; Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Affective Symptoms
• Other Study ID Numbers: MedeniyetRomato

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No