Mood DisordersNCT05535270
Validation of the Chinese Version of Oxford Depression Questionnaire
An observational study of Mood Disorders and Emotional Blunting, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Mood disorders are a group of psychiatric disorders that can affect a person's mood, energy, and motivation. Emotional blunting has been observed in clinical practice in patients with mood disorders. Emotional blunting has a negative impact on patients' overall treatment and leads to poorer adherence. Read more about this study
- Who is it for?
- Ages 13 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disorders, Emotional Blunting
- What is being tested?
- Oxford Depression Questionnaire (ODQ)
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jun 2023
- 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 13 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with mood disorders are recruited as outpatients or inpatients with the First Affiliated Hospital of Zhejiang University, School of Medicine.
Who may be able to join
- 1) both biological parents were Han Chinese; 2) currently diagnosed with major depressive disorder or bipolar disorder according to the Mini International Neuropsychiatric Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; 3) aged 13-65 years; 4) can complete the self-assessment questionnaires.
Who cannot join
- 1) currently diagnosed with neurological diseases or other major psychiatric disorders, e.g., schizophrenia, cognitive impairment, substance abuse; 2) diagnosed with severe somatic illnesses, such as diabetes and cardiovascular diseases;
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Psychometric Properties of the Oxford Depression Questionnaire in Chinese Patients With Mood Disorders
Mood disorders are a group of psychiatric disorders that can affect a person's mood, energy, and motivation. Emotional blunting has been observed in clinical practice in patients with mood disorders. Emotional blunting has a negative impact on patients' overall treatment and leads to poorer adherence. The Oxford Depression Questionnaire (ODQ) is a measuring instrument of emotional blunting. The ODQ is expected to be a scientifically valid tool for detecting emotional blunting. The ODQ has high construct validity and internal reliability. However, no scientific validity studies have been conducted on ODQ in Chinese population. Therefore, this study is intended to investigate the reliability and validity of the ODQ in Chinese patients with mood disorders.
- Conditions
- Mood Disorders, Emotional Blunting
- Being tested
- Oxford Depression Questionnaire (ODQ)
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford Depression Questionnaire (ODQ)Diagnostic test
The Oxford Depression Questionnaire (ODQ)is a patient-centered questionnaire. The scale contains three sections: i) the patient's experience in the past week; ii) the patient's experience before the illness worsened, and iii) the patient's emotional feelings about receiving antidepressant treatment. The 26-item questionnaire contains four dimensions of "emotional blunting": not caring (NC), emotional detachment from others (ED), reduction in positive emotions (RP), and general reduction in emotions (GR). Patients not taking antidepressants were only required to rate the first two sections .
| Study group | Role | What they receive |
|---|---|---|
| Mood Disorder patients | The participants completed a demographic questionnaire, the self-report Oxford Depression Questionnaire (ODQ-C), the Beck Depression Inventory-II(BDI-II), and the Montgomery-Asberg Depression Rating Scale (MADRS). Receives: Diagnostic Test: Oxford Depression Questionnaire (ODQ) | |
| Healthy Controls | The participants completed a demographic questionnaire, Patient Health Questionnaire - 9(PHQ-9), and the first two sections of Oxford Depression Questionnaire (ODQ-20). Receives: Diagnostic Test: Oxford Depression Questionnaire (ODQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Depression Questionnaire (ODQ)
To analyze reliability and validity of the ODQ.
Measured: baseline
Secondary outcomes (3)
Beck Depression Inventory-II (BDI-II)
To analyze criterion validity of the Chinese version of the ODQ
Measured: baseline
Montgomery-Asberg Depression Rating Scale (MADRS)
To analyze correlation with ODQ
Measured: baseline
Oxford Depression Questionnaire (ODQ)
To analyze Test-retest reliability coefficients of the ODQ.
Measured: 2 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Jan 2022
- Primary completion1 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu ShaoHua, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535270
- Sponsor's protocol ID
- IIT20220240B-R1
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Arms and interventions can be shared, while the clinical data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of the Oxford Depression Questionnaire in Chinese Patients With Mood Disorders
- ClinicalTrials.gov ID
- NCT05535270
- Acronym / sponsor ID
- IIT20220240B-R1
- Conditions
- Mood Disorders, Emotional Blunting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 10 Sep 2022 (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.
Mood disorders are a group of psychiatric disorders that can affect a person's mood, energy, and motivation. Emotional blunting has been observed in clinical practice in patients with mood disorders. Emotional blunting has a negative impact on patients' overall treatment and leads to poorer adherence. The Oxford Depression Questionnaire (ODQ) is a measuring instrument of emotional blunting. The ODQ is expected to be a scientifically valid tool for detecting emotional blunting. The ODQ has high construct validity and internal reliability. However, no scientific validity studies have been conducted on ODQ in Chinese population. Therefore, this study is intended to investigate the reliability and validity of the ODQ in Chinese patients with mood disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mood Disorder patients | – | Diagnostic Test: Oxford Depression Questionnaire (ODQ)The participants completed a demographic questionnaire, the self-report Oxford Depression Questionnaire (ODQ-C), the Beck Depression Inventory-II(BDI-II), and the Montgomery-Asberg Depression Rating Scale (MADRS). |
| Healthy Controls | – | Diagnostic Test: Oxford Depression Questionnaire (ODQ)The participants completed a demographic questionnaire, Patient Health Questionnaire - 9(PHQ-9), and the first two sections of Oxford Depression Questionnaire (ODQ-20). |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with mood disorders are recruited as outpatients or inpatients with the First Affiliated Hospital of Zhejiang University, School of Medicine.
Key inclusion criteria (1 listed)
- 1) both biological parents were Han Chinese; 2) currently diagnosed with major depressive disorder or bipolar disorder according to the Mini International Neuropsychiatric Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; 3) aged 13-65 years; 4) can complete the self-assessment questionnaires.
Key exclusion criteria (1 listed)
- 1) currently diagnosed with neurological diseases or other major psychiatric disorders, e.g., schizophrenia, cognitive impairment, substance abuse; 2) diagnosed with severe somatic illnesses, such as diabetes and cardiovascular diseases;
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 |
|---|---|---|
| Oxford Depression Questionnaire (ODQ)The Oxford Depression Questionnaire (ODQ)is a patient-centered questionnaire. The scale contains three sections: i) the patient's experience in the past week; ii) the patient's experience before the illness worsened, and iii) the patient's emotional feelings about receiving antidepressant treatment. The 26-item questionnaire contains four dimensions of "emotional blunting": not caring (NC), emotional detachment from others (ED), reduction in positive emotions (RP), and general reduction in emotions (GR). Patients not taking antidepressants were only required to rate the first two sections . | Diagnostic test | Healthy Controls, Mood Disorder patients |
Primary outcome
Oxford Depression Questionnaire (ODQ)
Time frame: baseline
To analyze reliability and validity of the ODQ.
3 secondary outcomes
Beck Depression Inventory-II (BDI-II)
Time frame: baseline
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: baseline
Oxford Depression Questionnaire (ODQ)
Time frame: 2 weeks after baseline
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 15 Sep 2023.
- Individual participant dataSharing planned: No. Arms and interventions can be shared, while the clinical data will not be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders and Emotional Blunting, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 1 inclusion and 1 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Oxford Depression Questionnaire (ODQ) (time frame: baseline). 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 15 Sep 2023.