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NCT Number: NCT06702839

Effect of BETY on Biopsychosocial States Associated With Chronic Pain in Rheumatic Individuals.

No study has been found in the literature investigating the effectiveness of an innovative exercise approach defined on a biopsychosocial basis and having its own original scale on individuals with rheumatism over the years. The aim of this retrospective study was to determine the effects of the Cognitive Exercise Therapy Approach on the biopsychosocial conditions related to chronic pain; functionality, mood and quality of life of individuals with rheumatism diagnosis and to examine the effectiveness of BETY as a routine exercise approach by presenting the results compared with the control group.

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Key information

Conditions

Rheumatic Diseases Behavior Chronic Pain Connective Tissue Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Samanpazar, 06100, Turkey (Türkiye)

About this study

Cognitive Exercise Therapy Approach (BETY) is an innovative exercise approach developed through the participation of rheumatic individuals in exercise sessions for many years. The main purpose of BETY is to transfer the patient's negative cognitions about their disease to a positive cognition level through functional gains through exercise. Thus, cognitive restructuring will be achieved.

In order to correctly organize the optimum treatment, rheumatic patients need to be evaluated biopsychosocially. Individual-centered scales that evaluate the disease process are currently considered at least as much as objective tests in determining treatment effectiveness and are increasingly used in clinical practice. Due to the multidimensional structure of chronic diseases, there is a need for measurement tools that evaluate individuals in a biopsychosocial context. BETY-Biopsychosocial Scale (BETY-BQ) was developed for this purpose with the feedback of the recovery characteristics of rheumatic individuals who participated in BETY sessions over the years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who were diagnosed as Ankylosing spondylitis (1984 modified New York criteria, RA (2010 ACR/EULAR criteria), PsA (2006 CASPAR criteria), SLE (2012 Systemic Lupus International Collaborating Clinics criteria), SSc (2013 ACR/EULAR criteria), pSS (American-European Consensus Group criteria), OA (1986 ACR criteria) and FMS (2016 ACR criteria)

Exclusion criteria

  • Patients who had severe cognitive problems

Treatment and study plan

BETY (Cognitive Exercise Therapy Approach )

Other

Individuals with rheumatism were included in BETY sessions after the first session, which included functional gain with function-focused trunk stabilization exercises for their complaints and chronic pain management training based on neuroscience. BETY sessions included function-focused trunk stabilization exercises, chronic pain management, mood information management (dance therapy - authentic movement) as innovative. Individuals were included in a separate session of sexual information management and sleep education.

3 days a week for 3 months

Home exercise program

Other

Exercises have been shown and a brochure has been given The individuals in this group were mostly individuals from out of town who were given home exercise recommendations directed by a rheumatologist.

Primary outcomes

  1. BETY-Biopsychosocial Questionnaire (BETY-BQ):

    Time frame: 3 months

    it is a 30-item Likert-type scale developed through repeated statistics of feedback from rheumatic individuals who have participated in exercise sessions for many years, expressing the healing characteristics. It evaluates the individual from a biopsychosocial perspective with the subheadings of pain, functionality-fatigue, mood, sociability, sexuality and sleep. It is scored between 0 and 120. BETY-BQ evaluates the individual from a holistic perspective with six subheadings: pain (5 items), functionality (9 items), mood (10 items), sociability (3 items), sexuality (2 items) and sleep (1 item). A high score indicates a low biopsychosocial status.

Secondary outcomes

  1. Health Assessment Questionnaire (HAQ)

    Time frame: 3 months

    It is a scale developed to question functional inadequacy in daily living activities. The scale questions a total of 8 activities, including dressing, sitting up, eating, walking, hygiene, reaching out, grasping and daily tasks, and consists of 20 questions. Each question is scored between 0 and 3. High scores indicate a decrease in the individual's functionality.

  2. Hospital Anxiety Depression Scale (HADS)

    Time frame: 3 months

    It is a scale consisting of 14 questions (7 questions about depression, 7 questions about anxiety) that the individual is asked to answer by thinking about the last few days, and is scored between 0 and 3. The cut-off values of the scale are 10 for the anxiety subscale and 7 for the depression subscale. High total scores indicate high levels of anxiety or depression

  3. Short Form - 36 (SF-36)

    Time frame: 3 months

    SF-36, which is widely used in assessing quality of life, is a scale consisting of 8 sub-parameters: physical function (FF), social function (SF), role limitations due to physical problems, role limitations due to emotional problems, pain, energy level-vitality, mental health and general health perception. Each sub-parameter is scored between 0 and 100. High scores indicate good health status (35).

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Collaborators

  • Hacettepe University

Registry information

Official study title

Investigation of the Effects of BETY on Biopsychosocial Status, Functionality, Mood and Quality of Life of Individuals Diagnosed With Rheumatism and Related to Chronic Pain: A Retrospective Controlled Study

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Nov 25, 2024
Registry last updated
Dec 2, 2025

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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