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NCT Number: NCT04630327

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

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.

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Key information

Conditions

Depression Adnexal Diseases Anxiety Anxiety Disorders Behavior Behavioral Symptoms Breast Cancer Breast Diseases Breast Neoplasms Cervical Cancer Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Mental Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Almaty Oncology Center, Almaty, Kazakhstan

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Who can participate

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

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

Treatment and study plan

Beck Depression Inventory-21 (diagnostic survey)

Other

Kazakh or Russian versions of the Beck Depression Inventory-21will be filled by female cancer patients

Other names: BDI-II

Beck Anxiety Inventory

Other

Kazakh or Russian versions of the Beck Anxiety Inventory will be filled by female cancer patients

Other names: BAI

Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria

Other

Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria as a gold standard of diagnosing depression or anxiety

Primary outcomes

  1. BDI-II Score at Baseline:

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Kazakh Medical University of Continuing Education

Other

Registry information

Official study title

Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory Among Female Cancer Patients

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 16, 2020
Registry last updated
Jun 21, 2022

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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