NCT05535270

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

September 6, 2022

Last Update Submit

September 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oxford Depression Questionnaire (ODQ)

    To analyze reliability and validity of the ODQ.

    baseline

Secondary Outcomes (3)

  • Beck Depression Inventory-II (BDI-II)

    baseline

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    baseline

  • Oxford Depression Questionnaire (ODQ)

    2 weeks after baseline

Study Arms (2)

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).

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).

Diagnostic Test: Oxford Depression Questionnaire (ODQ)

Interventions

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 .

Healthy ControlsMood Disorder patients

Eligibility Criteria

Age13 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with mood disorders are recruited as outpatients or inpatients with the First Affiliated Hospital of Zhejiang University, School of Medicine.

You may qualify if:

  • \) 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.

You may not qualify if:

  • \) 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 10, 2022

Study Start

January 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 30, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Arms and interventions can be shared, while the clinical data will not be shared

Locations