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

December 1, 2025 updated by: Sevim Öksüz, Eastern Mediterranean University

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Samanpazar
      • Ankara, Samanpazar, Turkey (Türkiye), 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY)
3 days a week for 3 months

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

Active Comparator: Home exercise program
For 3 months
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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 months
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Nur Banu Karaca, MSc. PT., Hacettepe University
  • Study Director: Sedat Kiraz, Prof. Dr., Hacettepe University
  • Principal Investigator: Aykut Ozçadırcı, Hacettepe University
  • Principal Investigator: Orkun Tüfekçi, MSc. PT., Hacettepe University
  • Principal Investigator: Aysima Barlak, Hacettepe University
  • Study Director: Ali Akdoğan, Prof. Dr., Hacettepe University
  • Study Chair: Edibe Unal, Prof. Dr., Hacettepe University
  • Principal Investigator: Sevim Oksüz, PhD. PT., Eastern Mediterranean University
  • Study Director: Şule Apraş Bilgen, Prof. Dr., Hacettepe University
  • Study Director: Robert D. Gerwin, MD., Johns Hopkins University
  • Study Director: Rinnie Geenen, Prof. Dr., Utrecht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Actual)

November 25, 2024

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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