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Clinical Trials/NCT04630327
NCT04630327
Completed
Not Applicable

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

Kazakh Medical University of Continuing Education2 sites in 1 country226 target enrollmentJanuary 13, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Kazakh Medical University of Continuing Education
Enrollment
226
Locations
2
Primary Endpoint
BDI-II Score on day 14
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2020
End Date
May 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Kazakh Medical University of Continuing Education
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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".

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.

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".

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.

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".

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.

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.

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.

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).

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).

Study Sites (2)

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