Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory

Sponsor
Kazakh Medical University of Continuing Education (Other)
Overall Status
Completed
CT.gov ID
NCT04630327
Collaborator
(none)
226
2
27.6
113
4.1

Study Details

Study Description

Brief Summary

Depression and anxiety in female patients with cancer are serious comorbidities that affect the quality of life for patients and their survival rates as they have poorer health outcomes. This validation study is a part of the study on the prevalence of depression and anxiety among breast cancer patients. This study aims to investigate the validity of the Kazakh and Russian versions of the Beck Depression Inventory (BDI-II) and Beck Anxiety Inventory (BAI) among female cancer patients in Almaty, Kazakhstan.

Condition or Disease Intervention/Treatment Phase
  • Other: Beck Depression Inventory-21 (diagnostic survey)
  • Other: Beck Anxiety Inventory
  • Other: Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria

Study Design

Study Type:
Observational
Actual Enrollment :
226 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory Among Female Cancer Patients
Actual Study Start Date :
Jan 13, 2020
Actual Primary Completion Date :
Apr 28, 2022
Actual Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Female Cancer Patients

Female cancer patients with no history of previously diagnosed depression or anxiety and who have been referred to or have been receiving treatment at Almaty Oncology Center or Kazakh Scientific Research Institute of Oncology and Radiology

Other: Beck Depression Inventory-21 (diagnostic survey)
Kazakh or Russian versions of the Beck Depression Inventory-21will be filled by female cancer patients
Other Names:
  • BDI-II
  • Other: Beck Anxiety Inventory
    Kazakh or Russian versions of the Beck Anxiety Inventory will be filled by female cancer patients
    Other Names:
  • BAI
  • Other: Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria
    Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria as a gold standard of diagnosing depression or anxiety

    Outcome Measures

    Primary Outcome Measures

    1. BDI-II Score at Baseline: [Baseline]

      Beck Depression Inventory (BDI-II) Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.

    2. BDI-II Score on day 14 [Day 14]

      Beck Depression Inventory (BDI-II) Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.

    3. BAI Score at Baseline [Baseline]

      Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and 26 - 63 as "Severe".

    4. BAI Score Day 14 [Day 14]

      Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and 26 - 63 as "Severe".

    5. ICD-10 diagnosis at baseline [Baseline]

      The ICD-10 sets criteria for diagnosis of major depressive disorder and generalized anxiety disorder, and will be used as a gold standard of diagnosis of depression and anxiety.

    6. ICD-10 diagnosis on Day 14 [Day 14]

      The ICD-10 sets criteria for diagnosis of major depressive disorder and generalized anxiety disorder, and will be used as a gold standard of diagnosis of depression and anxiety.

    7. Internal consistency of the BAI [Day 14]

      Internal consistency of the subscales will be evaluated with Cronbach's alpha. Values between 0.70 and 0.90 will be considered good and greater than 0.90 will be considered excellent.

    8. Internal consistency of the BDI-II [Day 14]

      Internal consistency of the subscales will be evaluated with Cronbach's alpha. Values between 0.70 and 0.90 will be considered good and greater than 0.90 will be considered excellent.

    9. Test - retest reliability of the BDI-II questtionaire [Day 14]

      Test - retest reliability of the BDI-II questtionaire on Day 14. Test-retest reliability coefficients vary between 0 and 1, where: 1 : perfect reliability, 0.9: excellent reliability, 0.8 < 0.9: good reliability, 0.7 < 0.8: acceptable reliability, 0.6 < 0.7: questionable reliability, 0.5 < 0.6: poor reliability, < 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).

    10. Test - retest reliability of the BAI questtionaire [Day 14]

      Test - retest reliability of the BAI questtionaire on Day 14. Test-retest reliability coefficients vary between 0 and 1, where: 1 : perfect reliability, 0.9: excellent reliability, 0.8 < 0.9: good reliability, 0.7 < 0.8: acceptable reliability, 0.6 < 0.7: questionable reliability, 0.5 < 0.6: poor reliability, < 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).

    11. Sensitivity and Specificity of the BDI-II at baseline [Baseline]

      Sensitivity and Specificity of the BDI-II at baseline compared to ICD-10 criteria. Beck Depression Inventory (BDI-II) Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.

    12. Sensitivity and Specificity of the BAI at baseline [Baseline]

      Sensitivity and Specificity of the BAI at baseline compared to ICD-10 criteria. Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and 26 - 63 as "Severe".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:
    • adult female patients between 18 and 65 years of age with a primary diagnosis of breast cancer; ovarian cancer; cervical cancer; colon cancer; lung cancer;

    • Russian or Kazakh language fluency;

    • consent to participate;

    Exclusion Criteria:
    • history of diagnosed depression or anxiety;

    • current use of antidepressants;

    • referral to palliative care

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kazakh Scientific Research Institute of Oncology and Radiology Almaty Kazakhstan 050012
    2 Almaty Oncology Center Almaty Kazakhstan 050054

    Sponsors and Collaborators

    • Kazakh Medical University of Continuing Education

    Investigators

    • Study Director: Botagoz Turdaliyeva, Professor, Kazakh Medical University of Continuing Education

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kazakh Medical University of Continuing Education
    ClinicalTrials.gov Identifier:
    NCT04630327
    Other Study ID Numbers:
    • 06-2020/1
    First Posted:
    Nov 16, 2020
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kazakh Medical University of Continuing Education
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 21, 2022