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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression, Anxiety, Breast Cancer, Ovarian Cancer, Cervical Cancer, Lung Cancer, Colon Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female Cancer Patients<br>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)<br>* Kazakh or Russian versions of the Beck Depression Inventory-21will be filled by female cancer patients<br>* Other names: BDI-II;Other: Beck Anxiety Inventory<br>* Kazakh or Russian versions of the Beck Anxiety Inventory will be filled by female cancer patients<br>* Other names: BAI;Other: Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria<br>* Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria as a gold standard of diagnosing depression or anxiety<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, anxiety, breast cancer, validation study, female cancer patients