Alexithymia in Ankylosing Spondylitis
1 other identifier
observational
110
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2016
CompletedFirst Submitted
Initial submission to the registry
March 22, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedMarch 25, 2020
March 1, 2020
6 months
March 22, 2020
March 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
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
healthy control
age and sex matched healthy controls
Interventions
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.
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.
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.
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).
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.
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.
Eligibility Criteria
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.
You may qualify if:
- Diagnosed as AS for at least 1 year according to the ASAS classification criteria
- over 18 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Istanbul, 34732, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Research Assistant of PMR
Study Record Dates
First Submitted
March 22, 2020
First Posted
March 25, 2020
Study Start
February 1, 2016
Primary Completion
August 1, 2016
Study Completion
August 15, 2016
Last Updated
March 25, 2020
Record last verified: 2020-03