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

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186830
• Other study ID #: 2023/1361
• Status: Recruiting
• Start date: December 17, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Hacettepe University
• Contact: Harun Gençosmanoglu, PT, MSc
• Phone: +903704189093
• Email: harungencosmanoglu[@]karabuk.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• Validity and reliability analyses
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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara
Turkey	Karabük University	Karabük

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Karabuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Responsiveness of BETY-BQ	The Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire will be repeated on same 30 individuals at 3-month intervals.	From baseline to 3rd month
Primary	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