Quality of Life in Chinese Working and School Age Population With MDD

A Survey of Quality of Life in Chinese Working and School Age Population With Major Depressive Disorder

Major depressive disorder (MDD) is a common mental illness with high prevalence and global burden. Previous studies revealed that over 70% patients in remission still had decreased quality of life, severe function impairment, low positive mental health score and poor coping ability. However, few studies focus on working and school age patients with MDD. A GBD survey showed that over 40% MDD patients are 15-50 years old. Therefore, we initiate the present multi-center cross-sectional survey to investigate the associations between clinical symptoms, cognitive function, occupational/study ability, and quality of life in Chinese working and school age population with MDD who are in remission.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder; Remission
• Intervention / Treatment: Other: treatment as usual

Detailed Description

This is a multi-center cross-sectional study. Patients with MDD who received medication treatment and achieved remission for at least 8 weeks will be enrolled. For all the participants, demographic information will be collected; clinical symptoms, cognitive function, occupational/study ability, and quality of life will be evaluated by using 17-items HAMD, PHQ-9, HAMA, PSQI, SHAPS, HCL-32, SDS, LEAPS, QOL-6, PFQ and THINC-it toolkit.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Tao Yang, M.D.; Phone Number: +86 15800579832; Email: yangtao2015sjtu@foxmail.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with MDD in working and school age who recieved medication treatment and achieved remission for at leat 8 weeks.

Description

Inclusion Criteria:

• Out-patients;
• Men or women aged between 16 and 50, with junior high school education or above;
• According to medical history, patients should be diagnosed with major depressive episode by two or above psychiatric doctors based on ICD-10 criteria;
• According to assessment, patients should meet the DSM-5 criteria for MDD when in past episodes;
• Patients received stable ant-depression medication treatment for at least 8 weeks before enrolment;
• 17-item HAMD total score ≤ 7;
• Willing to participate in this study, and sign an informed consent.

Exclusion Criteria:

• HCL-32 total score < 12;
• Diagnosed with bipolar disorder;
• Suffering from some serious physical diseases (e.g. moderate or severe brain injury, central nervous system diseases, or other unstable physical condition affecting the whole body) adversely affects the performance on neuropsychological test or rating scales;
• Received ECT in the past 6 months.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MDD patients; No intervention.	Other: treatment as usual; No inervention. Treatment regime remains unchanged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Sheehan disability scale (SDS)	To evaluate the functional impairment, including work/study, daily life and family responsibility. The score of each subscale ranged from 0 to 10 which means from no impairment to loss of function.	up to 1 weeks
Quality of Life, short form 6 (QOL-6)	To evaluate the quality of life in patients with MDD. The higher the total score, the better the quality of life.	up to 4 weeks
The Psychosocial Function Questionnaire in Patients with Depression (PFQ)	To evaluate the psychosocial function of patients with MDD. The lower total score means the severer psychosocial function impairment.	up to 1 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Lam Employment Absence and Productivity Scale (LEAPS)	To evaluate the work capacity. The higher total score means the severer impairment of work capacity.	up to 2 weeks
The Hamilton Depression Scale-17 items (HAMD)	To evaluate the severity of depressive symptoms by clinicians. Remission: total score < 7.	up to 1 weeks
Patient Health Questionnaire-9 (PHQ-9)	to evaluate the severity of depressive symptoms by patients. Remission: total score < 4.	up to 2 weeks
The Hamilton Anxiety Scale (HAMA)	To evaluate the severity of anxiety symptoms by clinicians. The total score < 6: no anxiety sympotom.	up to 1 weeks
Pittsburgh Sleep Quality Index (PSQI)	To evaluate the sleep quality. The lower the total score, the better sleep quality (<5).	up to 4 weeks
The Snaith-Hamilton Pleasure Scale (SHAPS)	To evaluate the severity of anhedonia. The higher total score means the severer of anhedonia.	up to 4 weeks
THINC-it toolkit	To assess the cognitive function in patients with MDD specifically. The composite THINC-it tool score is the integrated total score of results from performance on five sub-component cognitive tests of the THINC-it tool.	up to 1 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: Beijing HuiLongGuan Hospital; Guangzhou Psychiatric Hospital; Huaxi Hospital; Second Xiangya Hospital, Central South University; Nanjing Brain Hospital, Nanjing Medical University; The First Affiliated Hospital of Medical College, Xi'an Jiaotong University
• Investigators: Principal Investigator: Jun Chen, M.D., Ph.D, Shanghai Mental Health Center (SMHC)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): August 30, 2021
• Study Completion (Anticipated): August 30, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; cognitive function; social function; working and school age population
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2020-76

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No