DepressionNCT04630327
Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory
An observational study of Depression and Anxiety, run by Kazakh Medical University of Continuing Education at 2 sites in Kazakhstan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Depression, Anxiety, Breast Cancer
- What is being tested?
- Beck Depression Inventory-21 (diagnostic survey), Beck Anxiety Inventory and Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria
- How many people
- 226 participants
- Where
- 2 sitesKazakhstan
- Study dates
- 13 Jan 2020to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Study population: 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; who have been referred to or have been receiving treatment at Almaty Oncology Center or Kazakh Scientific Research Institute of Oncology and Radiology
Who may be able to join
- 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;
Who cannot join
- history of diagnosed depression or anxiety;
- current use of antidepressants;
- referral to palliative care
Trial locations and contacts
2 sites in 1 country.
Kazakhstan2 sites
Kazakh Scientific Research Institute of Oncology and Radiology
Almaty, 050012
Almaty Oncology Center
Almaty, 050054
About this study
Official title: Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory Among Female Cancer Patients
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.
- Conditions
- Depression, Anxiety, Breast Cancer, Ovarian Cancer, Cervical Cancer, Lung Cancer
- Being tested
- Beck Depression Inventory-21 (diagnostic survey), Beck Anxiety Inventory, Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria
- Keywords
- depression, anxiety, breast cancer, validation study, female cancer patients
- Medical subject headings
- Depression, Anxiety Disorders, Breast Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Lung Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beck Depression Inventory-21 (diagnostic survey)Other
Also called BDI-II
Kazakh or Russian versions of the Beck Depression Inventory-21will be filled by female cancer patients
Beck Anxiety InventoryOther
Also called BAI
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) criteriaOther
Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria as a gold standard of diagnosing depression or anxiety
| Study group | Role | What they receive |
|---|---|---|
| Female Cancer Patients | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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".
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start13 Jan 2020
- Primary completion28 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazakh Medical University of Continuing Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Botagoz Turdaliyeva, Professor, Study director, Kazakh Medical University of Continuing Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630327
- Sponsor's protocol ID
- 06-2020/1
- Status last verified
- Jun 2022
- First submitted
- 10 Nov 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-identifiable IPD will be shared upon request with all required information
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory Among Female Cancer Patients
- ClinicalTrials.gov ID
- NCT04630327
- Acronym / sponsor ID
- 06-2020/1
- Conditions
- Depression, Anxiety, Breast Cancer, Ovarian Cancer, Cervical Cancer, Lung Cancer
- Keywords
- depression, anxiety, breast cancer, validation study, female cancer patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Kazakh Medical University of Continuing EducationUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female Cancer Patients | – | Other: Beck Depression Inventory-21 (diagnostic survey), Other: Beck Anxiety Inventory, Other: Interview using The International Classification of Diseases in tenth edition (ICD-10) criteriaFemale 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- 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; who have been referred to or have been receiving treatment at Almaty Oncology Center or Kazakh Scientific Research Institute of Oncology and Radiology
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- history of diagnosed depression or anxiety;
- current use of antidepressants;
- referral to palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beck Depression Inventory-21 (diagnostic survey)Also: BDI-IIKazakh or Russian versions of the Beck Depression Inventory-21will be filled by female cancer patients | Other | Female Cancer Patients |
| Beck Anxiety InventoryAlso: BAIKazakh or Russian versions of the Beck Anxiety Inventory will be filled by female cancer patients | Other | Female Cancer Patients |
| Interview using The International Classification of Diseases in tenth edition (ICD-10) criteriaInterview using The International Classification of Diseases in tenth edition (ICD-10) criteria as a gold standard of diagnosing depression or anxiety | Other | Female Cancer Patients |
Primary outcome
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.
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.
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".
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".
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.
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.
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.
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).
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.
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Yes. Non-identifiable IPD will be shared upon request with all required information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Botagoz Turdaliyeva, Professor study director
Kazakh Medical University of Continuing Education
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Kazakh Medical University of Continuing Education at 2 sites in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDI-II Score at Baseline: (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.