CClinicalTrials.gg
CompletedNCT06702839Updated Dec 2, 2025

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

An interventional study of BETY (Cognitive Exercise Therapy Approach ) and Home exercise program in Rheumatic Diseases, sponsored by Eastern Mediterranean University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 3 months after the study started (first participant enrolled Aug 2017, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Rheumatic Diseases

Keywords

  • biopsychosocial
  • holistic
  • exercise
  • functioning
  • sleep
  • chronic pain
03

In context

Rheumatic Diseases

377 studies on the registry are indexed under Rheumatic Diseases; 79 are open to participants now.

This study's enrollment of 300 is above the median of 74 across 210 interventional studies indexed under Rheumatic Diseases.

Browse Rheumatic Diseases studies →

Lead sponsor

Eastern Mediterranean University is the lead sponsor of 136 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients who had severe cognitive problems
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY)

    3 days a week for 3 months

    Other: BETY (Cognitive Exercise Therapy Approach )

  • Active comparator
    Home exercise program

    For 3 months

    Other: Home exercise program

Interventions

  • OtherBETY (Cognitive Exercise Therapy Approach )

    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

  • OtherHome exercise program

    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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 3 months

Secondary outcomes

  1. Health Assessment Questionnaire (HAQ)

    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.

    Time frame: 3 months

  2. Hospital Anxiety Depression Scale (HADS)

    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

    Time frame: 3 months

  3. Short Form - 36 (SF-36)

    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).

    Time frame: 3 months

07

Study locations

1 site
  • Hacettepe University
    Ankara, Samanpazar 06100, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06702839
Lead sponsor
Eastern Mediterranean University
Collaborators
Hacettepe University
Responsible party
Sevim Öksüz (Asst. Prof. Dr., Eastern Mediterranean University) — Principal investigator
First posted
Nov 25, 2024
Start date
Aug 1, 2017
Primary completion
Aug 1, 2023
Completion
Aug 1, 2023
Last update
Dec 2, 2025

Study contacts

Aykut Ozçadırcı
principal investigator · Hacettepe University
Nur Banu Karaca, MSc. PT.
principal investigator · Hacettepe University
Orkun Tüfekçi, MSc. PT.
principal investigator · Hacettepe University
Aysima Barlak
principal investigator · Hacettepe University
Ali Akdoğan, Prof. Dr.
study director · Hacettepe University
Sedat Kiraz, Prof. Dr.
study director · Hacettepe University
Edibe Unal, Prof. Dr.
study chair · Hacettepe University
Sevim Oksüz, PhD. PT.
principal investigator · Eastern Mediterranean University
Şule Apraş Bilgen, Prof. Dr.
study director · Hacettepe University
Robert D. Gerwin, MD.
study director · Johns Hopkins University
Rinnie Geenen, Prof. Dr.
study director · Utrecht University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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