DepressionNCT07744295
Preoperative Anxiety and Depression Among Older Chinese Patients
An observational study of Depression and Anxiety, run by Chinese PLA General Hospital.
Trial summary
A multicenter, cross-sectional study to characterize the clinical profiles of the Chinese elderly population and to determine the prevalence of preoperative anxiety and depression. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Depression, Anxiety, Elderly Patients
- How many people
- 8,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients (aged ≥65 years) who completed the anxiety and depression assessment before elective non-cardiac major surgery were included in this study
Who may be able to join
- 1. Elderly patients (age ≥65 years) 2. Undergoing elective non-cardiac major surgery with a planned overnight hospital stay following surgery 3. Cognitive ability: Conscious, no severe cognitive impairment (MMSE score ≥24), able to cooperate with scale assessment
Who cannot join
- 1. Patients who refuse to participate in the study 2. Patients with severe dementia, language disorder, severe hearing or visual impairment, or cognitive impairment preventing assessment 3. Patients whose surgeries were canceled 4. History of previous severe mental illness (schizophrenia, bipolar disorder) or long-term use of psychotropic medications 5. Patients admitted to ICU immediately after surgery 6. Patients who did not complete the scale assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preoperative Anxiety and Depression Among Older Chinese Patients: A Multicenter Cross-sectional Study
A multicenter, cross-sectional study to characterize the clinical profiles of the Chinese elderly population and to determine the prevalence of preoperative anxiety and depression.
Read the detailed description
As China's population ages, the proportion of elderly people undergoing surgery increases. Perioperative anxiety and depression, particularly in elderly patients, is common and associated with multiple medical and social adversities. Previous studies have found a significant risk of anxiety and depression in older perioperative patients. However, nationally representative epidemiological data for preoperative anxiety and depression, in particular elderly patients undergoing non-cardiac major surgery, are unavailable in China.
Therefore, providing nationwide epidemiological data on preoperative anxiety and depression in Chinese elderly patients provides a valuable opportunity for policy makers and health care professionals to optimize the management of geriatric mental health in China.
- Conditions
- Depression, Anxiety, Elderly Patients, Non-cardiac Major Surgery
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients undergoing non-cardiac major surgery (aged ≥65 years) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative 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 ≥5, corresponding with at least a mild level of anxiety. Higher scores mean more anxiety.
Measured: Preoperative (within 3 days before surgery)
Preoperative Depression
Depression was assessed using the 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 ≥5, corresponding with at least a mild level of depression. The higher the score, the worse the situation. Higher scores indicate more depressive symptoms.
Measured: Preoperative (within 3 days before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
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.
- More trials run by Chinese PLA General HospitalThe 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
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xiangya Hospital of Central South University, Beijing Anzhen Hospital, Central South University, Peking University People's Hospital, Zhejiang University, Fudan University, Sun Yat-sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China-Japan Friendship Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Guangxi Medical University, Taihe Hospital, Zhejiang Provincial People's Hospital, Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744295
- Sponsor's protocol ID
- PLAGH-PREAD-Prevalence
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Anxiety and Depression Among Older Chinese Patients: A Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07744295
- Acronym / sponsor ID
- PLAGH-PREAD-Prevalence
- Conditions
- Depression, Anxiety, Elderly Patients, Non-cardiac Major Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xiangya Hospital of Central South University, Beijing Anzhen Hospital, Central South University, Peking University People's Hospital, Zhejiang University, Fudan University, Sun Yat-sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China-Japan Friendship Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Guangxi Medical University, Taihe Hospital, Zhejiang Provincial People's Hospital, Shanghai Zhongshan Hospital
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Aug 2026 (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.
A multicenter, cross-sectional study to characterize the clinical profiles of the Chinese elderly population and to determine the prevalence of preoperative anxiety and depression.
Detailed description
As China's population ages, the proportion of elderly people undergoing surgery increases. Perioperative anxiety and depression, particularly in elderly patients, is common and associated with multiple medical and social adversities. Previous studies have found a significant risk of anxiety and depression in older perioperative patients. However, nationally representative epidemiological data for preoperative anxiety and depression, in particular elderly patients undergoing non-cardiac major surgery, are unavailable in China.
Therefore, providing nationwide epidemiological data on preoperative anxiety and depression in Chinese elderly patients provides a valuable opportunity for policy makers and health care professionals to optimize the management of geriatric mental health in China.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients undergoing non-cardiac major surgery (aged ≥65 years) | – | – |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients (aged ≥65 years) who completed the anxiety and depression assessment before elective non-cardiac major surgery were included in this study
Key inclusion criteria (1 listed)
- 1. Elderly patients (age ≥65 years) 2. Undergoing elective non-cardiac major surgery with a planned overnight hospital stay following surgery 3. Cognitive ability: Conscious, no severe cognitive impairment (MMSE score ≥24), able to cooperate with scale assessment
Key exclusion criteria (1 listed)
- 1. Patients who refuse to participate in the study 2. Patients with severe dementia, language disorder, severe hearing or visual impairment, or cognitive impairment preventing assessment 3. Patients whose surgeries were canceled 4. History of previous severe mental illness (schizophrenia, bipolar disorder) or long-term use of psychotropic medications 5. Patients admitted to ICU immediately after surgery 6. Patients who did not complete the scale assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preoperative Anxiety
Time frame: Preoperative (within 3 days before surgery)
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 ≥5, corresponding with at least a mild level of anxiety. Higher scores mean more anxiety.
Preoperative Depression
Time frame: Preoperative (within 3 days before surgery)
Depression was assessed using the 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 ≥5, corresponding with at least a mild level of depression. The higher the score, the worse the situation. Higher scores indicate more depressive symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Chinese PLA General Hospital.
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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Cai (+8613718718781, 1607125811@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety (time frame: Preoperative (within 3 days before surgery)). The study lists 2 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 4 Aug 2026.