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NCT Number: NCT05600504

Development and Validation of a Prediction Model for Depression and Anxiety in Perioperative Elderly Adults

Anxiety and depression in later life are highly prevalent, often appear as comorbid disorders, and have many adverse consequences for both the individual and society. Given the disease burden, the large influx of new cases, and the economic costs, efforts should be made to prevent the onset of anxiety and depression in later life. Preventive interventions are likely to become more cost effective when they are targeted at elderly who have been exposed to risk factors known to be predictive of the onset of anxiety and/or depression. As the population aging is speeding up, senile diseases have become a significant and severe public health problem, influencing national health. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Therefore, it is necessary to construct a predictive model of anxiety and depression in perioperative elderly hospitalized patients

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Key information

Conditions

Predictive Model Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

About this study

More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Therefore, it is necessary to construct a predictive model of anxiety and depression in perioperative elderly hospitalized patients. In 2015, the WHO introduced the concept of "healthy ageing" for global ageing, with a focus on the mental health of older people at its core.

Previous studies have found a 31 percent risk of anxiety and 29 percent risk of depression in older perioperative patients. Therefore, optimizing perioperative mental health management in older patients remains one of the challenges facing clinicians.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective non-cardiac surgery,
  • American society of Aneshesiologists (ASA) classification Ⅰ ~ Ⅲ,
  • patients over age 65.

Exclusion criteria

  • patient refused follow-up study,
  • missing data exceeding 20%,
  • went to ICU or died after surgery,
  • have a history of any mental disorders such as epilepsy, Parkinson's disease, depression, anxiety, sleep disorders, or are currently taking relevant intervention drugs 5) patients with severe deafness, dementia or speech impairment.

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Depression

    Time frame: Depression within 7 days of surgery

    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.

Secondary outcomes

  1. Anxiety

    Time frame: Anxiety within 7 days of 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 ≥10, corresponding with at least a moderate level of anxiety. Higher scores mean more anxiety.

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Tiantan Hospital
  • Capital Medical University
  • China-Japan Friendship Hospital
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • Fudan University
  • Peking University First Hospital
  • Peking University People's Hospital
  • Shanghai Zhongshan Hospital
  • Sun Yat-sen University
  • Taihe Hospital
  • The Affiliated Hospital Of Guizhou Medical University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

A Prediction Model for Early Prediction of Depression and Anxiety in Perioperative Elderly Adults

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 31, 2022
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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