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RecruitingNCT06186830Updated Mar 13, 2025

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

An observational study in Temporomandibular Disorder, Temporomandibular Joint Disorders and Temporomandibular Joint Dysfunction Syndrome, sponsored by Hacettepe University. Recruiting at 2 sites in Turkey. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Hacettepe University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 64 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

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

Keywords

  • validity
  • reliability
  • responsiveness
03

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with temporomandibular disorder

Inclusion criteria

  • Having received a diagnosis of temporomandibular disorder

Exclusion criteria

Exclusion Criteria:

  • Experiencing difficulty in cooperating to fill out the questionnaires
  • Being unwilling to participate in the study
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with temporomandibular disorder

    Other: Validity and reliability analyses

Interventions

  • OtherValidity 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

  6. 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.

    Time frame: Baseline

  7. Test-retest stability of BETY-BQ

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

    Time frame: From baseline to 2nd week

  8. 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.

    Time frame: Baseline

06

Study locations

2 of 2 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06186830
Lead sponsor
Hacettepe University
Collaborators
Karabuk University
Responsible party
Harun Gençosmanoğlu (Principal Investigator, Karabuk University) — Principal investigator
First posted
Jan 2, 2024
Start date
Dec 17, 2023
Primary completion
Jul 15, 2024
Completion
Aug 2025 (estimated)
Last update
Mar 13, 2025

Study contacts

Harun Gençosmanoğlu, PT, MSc
Contact
harungencosmanoglu@karabuk.edu.tr
+903704189093 ext. 9093
Harun Gençosmanoğlu, PT, MSc
principal investigator · Karabük University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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