Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire (BETY-BQ) in Patient with Temporomandibular Disorders

NCT06186830 | Recruiting

• 1 other identifier: 2023/1361
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to investigate the validity, reliability, and responsiveness of the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ) in individuals with temporomandibular disorder. The following are alternative hypotheses of the study:

• BETY-BQ has significant convergence with the Patient Health Questionnaire-9 measuring depression.
• BETY-BQ has significant convergence with the Patient Health Questionnaire-15 measuring physical symptoms.
• BETY-BQ has significant convergence with the Generalized Anxiety Disorder-7 measuring anxiety.
• BETY-BQ has significant convergence with the Short Form-36 measuring quality of life.
• BETY-BQ has significant convergence with the Craniomandibular Pain and Disability Inventory measuring disability.
• BETY-BQ has significant convergence with the Mandibular Function Impairment Questionnaire measuring function.
• BETY-BQ has significant stability.
• BETY-BQ has significant internal consistency.

Conditions

Temporomandibular Disorder; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Keywords

validity; reliability; responsiveness

Outcome Measures

Primary Outcomes (8)

• Validity of BETY-BQ in measuring depression

  Patient Health Questionnaire-9. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.

  Baseline

• Validity of BETY-BQ in measuring physical symptoms

  Patient Health Questionnaire-15. Minimum and maximum values are 0 and 2 points, respectively. Higher scores mean a worse outcome.

  Baseline

• Validity of BETY-BQ in measuring anxiety

  Generalized Anxiety Disorder-7. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.

  Baseline

• Validity of BETY-BQ in measuring quality of life

  Short Form-36. It is a 36-item valid and reliable evaluation with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The SF-36 also contains a single question called "health transition" that measures how respondents feel their over health status has changed over the course of a year.

  Baseline

• Validity of BETY-BQ in measuring disability

  Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.

  Baseline

• Validity of BETY-BQ in measuring function

  Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.

  Baseline

• Test-retest stability of BETY-BQ

  The Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire will be repeated on 30 individuals with a 2-week interval.

  From baseline to 2nd week

• Internal consistency of BETY-BQ

  Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.

  Baseline

Study Arms (1)

Patients with temporomandibular disorder

Other: Validity and reliability analyses

Interventions

Validity and reliability analyses OTHER

Validity and reliability analyses will be performed using Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire, Patient Health Questionnaire-9, Patient Health Questionnaire-15, Generalized Anxiety Disorder-7, Short Form-36, Craniomandibular Pain and Disability Inventory, and Mandibular Function Impairment Questionnaire.

Patients with temporomandibular disorder

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with temporomandibular disorder

You may qualify if:

• Having received a diagnosis of temporomandibular disorder

You may not qualify if:

• Experiencing difficulty in cooperating to fill out the questionnaires
• Being unwilling to participate in the study

Sponsors & Collaborators

• Hacettepe University: lead
• Karabuk University: collaborator

Study Sites (2)

Karabük University

Karabük, Karabük Province, 78050, Turkey (Türkiye)

RECRUITING

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes

Study Officials

• Harun Gençosmanoğlu, PT, MSc

  Karabük University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harun Gençosmanoğlu, PT, MSc

CONTACT

+903704189093; harungencosmanoglu@karabuk.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 2, 2024
• Study Start: December 17, 2023
• Primary Completion: July 15, 2024
• Study Completion: August 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)