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

NCT06186830 — Recruiting, 150 participants, Hacettepe University

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Validity, Reliability and Responsiveness of the Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire in Individuals with Temporomandibular Disorder

RegistryNCT06186830
StatusRecruiting
Study typeObservational
Enrollment150 (Estimated)
SponsorHacettepe University (Other); collaborators: Karabuk University
ConditionsTemporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
InterventionsValidity and reliability analyses (Other)
Datesstart 2023-12-17, primary completion 2024-07-15, completion 2025-08-01 (estimated), first posted 2024-01-02, last updated 2025-03-13
Locations2 sites in Turkey (Türkiye)

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-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.

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+Detailed description

Patient Health Questionnaire-9 (Depression), Patient Health Questionnaire-15 (Physical Symptoms), Generalized Anxiety Disorder-7 (Anxiety), Short Form-36 (Quality of Life), Craniomandibular Pain and Disability Inventory (Disability), and Mandibular Function Impairment Questionnaire (Function) will be administered to participants. For reliability analysis, test-retest stability evaluations will be repeated with the same questionnaire on 30 individuals with a 2-week interval. To determine responsiveness, the same questionnaire will be reapplied to the same 30 individuals at 3-month intervals.

+Arms and interventions

ArmTypeInterventionsDescription
Patients with temporomandibular disorderOther: Validity and reliability analyses
  • 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.

+Outcome measures

Primary outcomes

  • Validity of BETY-BQ in measuring depression [Baseline]: Patient Health Questionnaire-9. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
  • Validity of BETY-BQ in measuring physical symptoms [Baseline]: Patient Health Questionnaire-15. Minimum and maximum values are 0 and 2 points, respectively. Higher scores mean a worse outcome.
  • Validity of BETY-BQ in measuring anxiety [Baseline]: Generalized Anxiety Disorder-7. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
  • Validity of BETY-BQ in measuring quality of life [Baseline]: 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.
  • Validity of BETY-BQ in measuring disability [Baseline]: Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
  • Validity of BETY-BQ in measuring function [Baseline]: Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
  • Test-retest stability of BETY-BQ [From baseline to 2nd week]: The Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire will be repeated on 30 individuals with a 2-week interval.
  • Internal consistency of BETY-BQ [Baseline]: Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.

+Eligibility

Sex: All, ages: 18 Years to 64 Years

Inclusion Criteria:

* Having received a diagnosis of temporomandibular disorder

Exclusion Criteria:

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

+Locations (2)

FacilityCityCountryStatus
Karabük UniversityKarabük, Karabük ProvinceTurkey (Türkiye)Recruiting
Hacettepe UniversityAnkaraTurkey (Türkiye)Recruiting

+Investigators

  • Harun Gençosmanoğlu, PT, MSc, Principal investigator, Karabük University

My Notes