Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory
- Conditions
- DepressionBreast CancerAnxietyOvarian CancerLung CancerCervical CancerColon Cancer
- Interventions
- Other: Beck Depression Inventory-21 (diagnostic survey)Other: Beck Anxiety InventoryOther: Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria
- Registration Number
- NCT04630327
- Lead Sponsor
- Kazakh Medical University of Continuing Education
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 226
- 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;
- history of diagnosed depression or anxiety;
- current use of antidepressants;
- referral to palliative care
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Female Cancer Patients Beck Anxiety Inventory 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 Female Cancer Patients Beck Depression Inventory-21 (diagnostic survey) 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 Female Cancer Patients Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria 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
- Primary Outcome Measures
Name Time Method 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.
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.
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".
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.
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".
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.
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".
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.
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.
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.
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).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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Kazakh Scientific Research Institute of Oncology and Radiology
🇰🇿Almaty, Kazakhstan
Almaty Oncology Center
🇰🇿Almaty, Kazakhstan