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

Recruiting

• Conditions: Temporomandibular Joint Dysfunction Syndrome; Temporomandibular Disorder; Temporomandibular Joint Disorders
• Interventions: Other: Validity and reliability analyses

• Registration Number: NCT06186830
• Lead Sponsor: Hacettepe University

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.

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.

Study Timeline

• Study Start: 2023-12-17
• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2023-12-17
• Study First Posted: 2024-01-02
• Primary Completion: 2024-07-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with temporomandibular disorder	Validity and reliability analyses	-

Primary Outcome Measures

Name	Time	Method
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 function	Baseline	Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 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.
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.

Trial Locations

Locations (2)

Hacettepe University; 🇹🇷 Ankara, Turkey

Karabük University; 🇹🇷 Karabük, Turkey