Alexithymia in Ankylosing Spondylitis

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: 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)

• Registration Number: NCT04320459
• Lead Sponsor: Istanbul Medeniyet University

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.

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 Timeline

• Study Start: 2016-02-01
• Primary Completion: 2016-08-01
• Study Completion: 2016-08-15
• Status Verified: 2020-03
• Study First Submitted: 2020-03-22
• Study First Submitted QC: 2020-03-22
• Last Update Submitted: 2020-03-22
• Study First Posted: 2020-03-25
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ankylosing spondylitis	Bath Ankylosing Spondylitis Metrology Index (BASMI)	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
ankylosing spondylitis	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	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	Bath Ankylosing Spondylitis Metrology Index (BASMI)	age and sex matched healthy controls
ankylosing spondylitis	Toronto Alexithymia Scale-20 (TAS-20)	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	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	age and sex matched healthy controls
healthy control	Bath Ankylosing Spondylitis Functional Index (BASFI)	age and sex matched healthy controls
healthy control	Beck's Depression Inventory (BDI)	age and sex matched healthy controls
ankylosing spondylitis	Bath Ankylosing Spondylitis Functional Index (BASFI)	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
ankylosing spondylitis	Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)	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	Toronto Alexithymia Scale-20 (TAS-20)	age and sex matched healthy controls
ankylosing spondylitis	Beck's Depression Inventory (BDI)	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	Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)	age and sex matched healthy controls

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department; 🇹🇷 Istanbul, Turkey