Postoperative Anxiety and Depression Among Older Chinese Patients

NCT06495840 | Completed

• 1 other identifier: PLAGH-AD-Prevalence
• Study Type: observational
• Target: 8,590
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, prospective observational study to describe the socioeconomic characteristics and the occurrence of postoperative anxiety and depression in the Chinese old population.

Conditions

Depression; Anxiety; Elderly Patients; Non-cardiac Surgery

Outcome Measures

Primary Outcomes (2)

• Anxiety

  The GAD-7 is a seven-item questionnaire for screening on the presence of generalized anxiety disorder and assessing its severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-one. Scores were defined as: ≥5 mild, ≥10 moderate, and ≥15 severe anxiety. The recommended screening cutoff was ≥10, corresponding with at least a moderate level of anxiety. Higher scores mean more anxiety.

  within 7 days after surgery

• Depression

  Primary outcomes were depression Patient Health Questionnaire 9 (PHQ-9).The PHQ-9 is a nine-item questionnaire for screening on the presence of depressive symptoms and monitoring depression severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-seven. Scores were defined as: ≥5 mild, ≥10 moderate, and ≥15 severe level of depression. The recommended screening cutoff was ≥10, corresponding with at least a moderate level of depression. The higher the score, the worse the situation. The total score ranges from 0 to 27, and higher scores indicate more depressive symptoms.

  within 7 days after surgery

Study Arms (1)

Elderly patients

elderly patients undergo non-cardiac surgery (aged ≥ 65 years)

Other: no intervention

Interventions

no intervention OTHER

no intervention

Elderly patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients (aged ≥ 65 years) who completed the anxiety and depression assessment after the elective noncardiac, non-neurosurgical surgery were included in this study.

You may qualify if:

• elderly patients (age ≥ 65 years)
• undergoing elective surgery with a planned overnight hospital stay following surgery
• non-cardiac surgery, non-neurosurgical surgery

You may not qualify if:

• patients fully refused to participate in the study
• patients with severe dementia, language disorder, severe hearing or visual impairment, coma, and end-stage status
• patients whose surgeries were canceled
• history of previous severe mental illness or long-term use of psychotropic medications
• patients admitted to ICU immediately after surgery
• patients who died within 7 days after surgery
• patients who did not complete the scale assessment

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Tiantan Hospital: collaborator
• Peking University First Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Xiangya Hospital of Central South University: collaborator
• Beijing Anzhen Hospital: collaborator
• Central South University: collaborator
• Peking University People's Hospital: collaborator
• Zhejiang University: collaborator
• Fudan University: collaborator
• Sun Yat-sen University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• China-Japan Friendship Hospital: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Taihe Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

First Medical center of Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Weidong Mi, PhD

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: April 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: September 20, 2024

Record last verified: 2024-07

Locations

CN (1)