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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630327
• Other study ID #: 06-2020/1
• Status: Completed
• Start date: January 13, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2022
• Source: Kazakh Medical University of Continuing Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: May 1, 2022
• Est. primary completion date: April 28, 2022
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Breast Cancer
• Cervical Cancer
• Colon Cancer
• Depression
• Depressive Disorder
• Lung Cancer
• Ovarian Cancer

Intervention

Other:
• Beck Depression Inventory-21 (diagnostic survey)
Kazakh or Russian versions of the Beck Depression Inventory-21will be filled by female cancer patients
• Beck Anxiety Inventory
Kazakh or Russian versions of the Beck Anxiety Inventory will be filled by female cancer patients
• 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

Locations

Country	Name	City	State
Kazakhstan	Almaty Oncology Center	Almaty
Kazakhstan	Kazakh Scientific Research Institute of Oncology and Radiology	Almaty

Sponsors (1)

Lead Sponsor	Collaborator
Kazakh Medical University of Continuing Education

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BDI-II Score at 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.	Baseline
Primary	BDI-II Score on 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.	Day 14
Primary	BAI Score at 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".	Baseline
Primary	BAI Score 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".	Day 14
Primary	ICD-10 diagnosis at 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.	Baseline
Primary	ICD-10 diagnosis on 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.	Day 14
Primary	Internal consistency of the BAI	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.	Day 14
Primary	Internal consistency of the BDI-II	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.	Day 14
Primary	Test - retest reliability of the BDI-II questtionaire	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).	Day 14
Primary	Test - retest reliability of the BAI questtionaire	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).	Day 14
Primary	Sensitivity and Specificity of the BDI-II at 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.	Baseline
Primary	Sensitivity and Specificity of the BAI at 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".	Baseline