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NCT Number: NCT06186830

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

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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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karabük University, Karabük, Karabük Province, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Validity of BETY-BQ in measuring depression

    Time frame: Baseline

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

  2. Validity of BETY-BQ in measuring physical symptoms

    Time frame: Baseline

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

  3. Validity of BETY-BQ in measuring anxiety

    Time frame: Baseline

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

  4. Validity of BETY-BQ in measuring quality of life

    Time frame: 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.

  5. Validity of BETY-BQ in measuring disability

    Time frame: Baseline

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

  6. Validity of BETY-BQ in measuring function

    Time frame: Baseline

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

  7. Test-retest stability of BETY-BQ

    Time frame: From baseline to 2nd week

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

  8. Internal consistency of BETY-BQ

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Harun Gençosmanoğlu, PT, MSc

CONTACT

[email protected]

+903704189093 ext. 9093

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Karabuk University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 2, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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