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Completed

NCT Number: NCT04320459

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department

Istanbul, 34732, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bath Ankylosing Spondylitis Metrology Index (BASMI)

Diagnostic Test

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.

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Diagnostic Test

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.

Bath Ankylosing Spondylitis Functional Index (BASFI)

Diagnostic Test

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.

Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)

Diagnostic Test

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).

Toronto Alexithymia Scale-20 (TAS-20)

Diagnostic Test

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.

Beck's Depression Inventory (BDI)

Diagnostic Test

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.

Primary outcomes

  1. Alexithymia rate in AS patients and controls according to Toronto Alexithymia Scale-20

    Time frame: 7 months

  2. Depression rate in AS patients and controls according to Beck Depression Inventory

    Time frame: 7 months

  3. Relationship between alexithymia and depression and functional indexes (BASFI, BASMI, BASDAI, ASQoL)

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2020
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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