Genetic Predisposition to DiseaseNCT06193005
Correlation Between Psychological Resilience and Genetic, Inflammatory Indicators
An observational study of Genetic Predisposition to Disease and Environment, run by Qianfoshan Hospital.
Trial summary
The goal of this observational study is to evaluate and analyze the influencing factors of the adaptive ability of young people, explore the impact of the interaction of environment and gene on the psychological adaptive ability of young people, incorporate the prediction model of the dynamic change of adaptive… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetic Predisposition to Disease, Environment, Adaptation, Psychological
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 18-24 years old young people
Who may be able to join
- Age 18-24 years old; high school graduation and above; agree to collect blood samples and sign an informed consent form.
Who cannot join
- Did not consent to the collection of blood samples; did not sign an informed consent form; suffered from a major illness such as a malignant tumor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study of the Correlation Between Psychological Resilience and Genetic, Inflammatory Indicators in Young Population
The goal of this observational study is to evaluate and analyze the influencing factors of the adaptive ability of young people, explore the impact of the interaction of environment and gene on the psychological adaptive ability of young people, incorporate the prediction model of the dynamic change of adaptive ability, build a standardized norm of young people's adaptive ability, and form a grading reference standard system. The main questions it aims to answer are:
- What are most important influencing factors for the adaptive ability of young people?
- How the environment and gene interact with each other on the psychological adaptive ability of young people?
- Can we build a prediction model of the dynamic change of adaptive ability and form a grading reference standard system?
Participants will support us with basic information data, adaptive ability assessment data, genetic testing data, brain image scanning data, and inflammatory indicators data. Then subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. And the statistical analysis will be performed by the data analyst.
Read the detailed description
18-24 years old is an important stage of psychological development and personality shaping of young people. The higher cortex of the brain, which is responsible for emotional regulation and environmental coping, enters a critical period of neuroplasticity development. Its psychological development is characterized by transition, closure and turbulence, etc. When facing the stressful environment such as college entrance, employment and rapid social development, depression, anxiety and other negative emotional experiences may occur. All kinds of psychological problems. According to the critical period theory of emotional development, emotional states and stress coping are regulated by the activities of the brain's higher cortex. At the same time, the occurrence of mental disorders such as adaptation disorders is also influenced by genetics, and people with high-risk genes are more likely to have disorders.
The purpose of this study is to focus on the evaluation and analysis of the influencing factors of the adaptive ability of young people, explore the impact of the interaction of environment and gene on the psychological adaptive ability of young people, incorporate the prediction model of the dynamic change of adaptive ability, build a standardized norm of young people's adaptive ability, and form a grading reference standard system.
Research contents: 1) According to the cognitive theory system of adaptive ability and the individual prediction model of adaptive ability, considering the environmental characteristics that affect the adaptive ability of young people, the evaluation items with high predictive power of the model are screened. 2) Test the adaptive ability evaluation system in the research objects, verify the reliability, validity and extensibility of the task, and verify the measurement reliability and ecological validity of the paradigm tool. 3) Representative populations with high and low adaptive ability were selected to conduct multi-dimensional data collection on genetics and brain nerve, study the genetic risk and risk gene loci of adaptive ability, analyze the brain image features corresponding to adaptive ability, and study the neural mechanism of adaptive ability.
This study was designed as a cross-sectional study, with young people aged 18-22 as the research objects. The inclusion criteria included 18-22 years old, high school graduation or above, consent to blood sample collection, and signed informed consent. Exclusion criteria include not agreeing to take blood samples, not signing informed consent forms, and having a major medical condition such as a malignant tumor. It is planned to recruit 400 subjects from January 1, 2024 to March 31, 2024, and collect basic information data, adaptive ability assessment data, genetic testing data, brain image scanning data, and inflammatory indicators data.
The subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. A variety of predictive modeling techniques (such as Logistic discriminant model, neural network model, decision tree, random forest model and support vector machine, etc.) are used to construct a dynamic change prediction model adapted to outcome risk. The internal validation of the model was carried out by using the ten-fold cross-validation method. The original data were divided into 10 groups, among which 9 groups were taken as the training set and 1 group was taken as the test set for cross-validation to ensure the stability of the model. ROC curve was drawn to evaluate the differentiation of evaluation models. The area under ROC curve synthesizes two indexes of sensitivity and specificity, and considers every possible threshold value, which can evaluate the diagnostic value of the model more objectively and accurately. By calculating the area AUC under ROC curve as a quantitative analysis of the diagnostic value of the model, the closer the AUC is to 1, the better the diagnostic effect is. The Hosmer-Lemeshow goodness of fit test was used to judge the degree of consistency between the predicted risk and the actual risk, so as to evaluate the calibration degree of the model.
- Being tested
- no intervention
- Medical subject headings
- Genetic Predisposition to Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| very low adaptive group | The subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. Receives: Other: no intervention | |
| low adaptive group | The subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. Receives: Other: no intervention | |
| high adaptive group | The subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. Receives: Other: no intervention | |
| very high adaptive group | The subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Assessment of the Psychological Resillience
Psychological Resillience was evaluated across multiple dimensions, including cognitive functioning, stress coping, psychological well-being, and personality traits, and was measured using internationally accepted scales. Psychological Resillience is measured using the Psychological Resilience Scale (CD-RISC), which consists of 25 items rated on a 5-point Richter's scale, with scores ranging from 0 to 4 indicating that this is not the case at all, seldom the case, sometimes the case, often the case, and almost always the case. The sum of the scores of the items is the total score of the scale, and the total score is 0~100, the larger the score indicates the higher the level of psychological resilience, and the score of less than 60 is the poor level of psychological resilience, 61~69 is the average level of psychological resilience, 70~79 is the good level of psychological resilience, and >=80 is the excellent level of psychological resilience.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Genetic Predisposition to DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Zhang, Qianfoshan Hospital
- Investigators
- Guang Zhang, Dr, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193005
- Sponsor's protocol ID
- SDHMC-231202
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Greenberg RL, Guzick AG, Schneider SC, Weinzimmer SA, Kook M, Perozo Garcia AB, Storch EA. Depressive Symptoms in Autistic Youth with Anxiety Disorders. J Dev Behav Pediatr. 2023 Dec 1;44(9):e597-e603. doi: 10.1097/DBP.0000000000001223. Epub 2023 Oct 11.
PubMed 38019467Brunette MF, Erlich MD, Edwards ML, Adler DA, Berlant J, Dixon L, First MB, Oslin DW, Siris SG, Talley RM. Addressing the Increasing Mental Health Distress and Mental Illness Among Young Adults in the United States. J Nerv Ment Dis. 2023 Dec 1;211(12):961-967. doi: 10.1097/NMD.0000000000001734.
PubMed 38015186Wong WLE, Arathimos R, Lewis CM, Young AH, Dawe GS. Investigating the role of the relaxin-3/RXFP3 system in neuropsychiatric disorders and metabolic phenotypes: A candidate gene approach. PLoS One. 2023 Nov 15;18(11):e0294045. doi: 10.1371/journal.pone.0294045. eCollection 2023.
PubMed 37967073
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Correlation Between Psychological Resilience and Genetic, Inflammatory Indicators in Young Population
- ClinicalTrials.gov ID
- NCT06193005
- Acronym / sponsor ID
- SDHMC-231202
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Jan 2024 (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.
The goal of this observational study is to evaluate and analyze the influencing factors of the adaptive ability of young people, explore the impact of the interaction of environment and gene on the psychological adaptive ability of young people, incorporate the prediction model of the dynamic change of adaptive ability, build a standardized norm of young people's adaptive ability, and form a grading reference standard system. The main questions it aims to answer are:
- What are most important influencing factors for the adaptive ability of young people?
- How the environment and gene interact with each other on the psychological adaptive ability of young people?
- Can we build a prediction model of the dynamic change of adaptive ability and form a grading reference standard system?
Participants will support us with basic information data, adaptive ability assessment data, genetic testing data, brain image scanning data, and inflammatory indicators data. Then subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. And the statistical analysis will be performed by the data analyst.
Detailed description
18-24 years old is an important stage of psychological development and personality shaping of young people. The higher cortex of the brain, which is responsible for emotional regulation and environmental coping, enters a critical period of neuroplasticity development. Its psychological development is characterized by transition, closure and turbulence, etc. When facing the stressful environment such as college entrance, employment and rapid social development, depression, anxiety and other negative emotional experiences may occur. All kinds of psychological problems. According to the critical period theory of emotional development, emotional states and stress coping are regulated by the activities of the brain's higher cortex. At the same time, the occurrence of mental disorders such as adaptation disorders is also influenced by genetics, and people with high-risk genes are more likely to have disorders.
The purpose of this study is to focus on the evaluation and analysis of the influencing factors of the adaptive ability of young people, explore the impact of the interaction of environment and gene on the psychological adaptive ability of young people, incorporate the prediction model of the dynamic change of adaptive ability, build a standardized norm of young people's adaptive ability, and form a grading reference standard system.
Research contents: 1) According to the cognitive theory system of adaptive ability and the individual prediction model of adaptive ability, considering the environmental characteristics that affect the adaptive ability of young people, the evaluation items with high predictive power of the model are screened. 2) Test the adaptive ability evaluation system in the research objects, verify the reliability, validity and extensibility of the task, and verify the measurement reliability and ecological validity of the paradigm tool. 3) Representative populations with high and low adaptive ability were selected to conduct multi-dimensional data collection on genetics and brain nerve, study the genetic risk and risk gene loci of adaptive ability, analyze the brain image features corresponding to adaptive ability, and study the neural mechanism of adaptive ability.
This study was designed as a cross-sectional study, with young people aged 18-22 as the research objects. The inclusion criteria included 18-22 years old, high school graduation or above, consent to blood sample collection, and signed informed consent. Exclusion criteria include not agreeing to take blood samples, not signing informed consent forms, and having a major medical condition such as a malignant tumor. It is planned to recruit 400 subjects from January 1, 2024 to March 31, 2024, and collect basic information data, adaptive ability assessment data, genetic testing data, brain image scanning data, and inflammatory indicators data.
The subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. A variety of predictive modeling techniques (such as Logistic discriminant model, neural network model, decision tree, random forest model and support vector machine, etc.) are used to construct a dynamic change prediction model adapted to outcome risk. The internal validation of the model was carried out by using the ten-fold cross-validation method. The original data were divided into 10 groups, among which 9 groups were taken as the training set and 1 group was taken as the test set for cross-validation to ensure the stability of the model. ROC curve was drawn to evaluate the differentiation of evaluation models. The area under ROC curve synthesizes two indexes of sensitivity and specificity, and considers every possible threshold value, which can evaluate the diagnostic value of the model more objectively and accurately. By calculating the area AUC under ROC curve as a quantitative analysis of the diagnostic value of the model, the closer the AUC is to 1, the better the diagnostic effect is. The Hosmer-Lemeshow goodness of fit test was used to judge the degree of consistency between the predicted risk and the actual risk, so as to evaluate the calibration degree of the model.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| very low adaptive group | – | Other: no interventionThe subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. |
| low adaptive group | – | Other: no interventionThe subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. |
| high adaptive group | – | Other: no interventionThe subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. |
| very high adaptive group | – | Other: no interventionThe subjects were divided into very low adaptive group, low adaptive group, high adaptive group and very high adaptive group according to the quartile of adaptive ability score. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 18-24 years old young people
Key inclusion criteria (1 listed)
- Age 18-24 years old; high school graduation and above; agree to collect blood samples and sign an informed consent form.
Key exclusion criteria (1 listed)
- Did not consent to the collection of blood samples; did not sign an informed consent form; suffered from a major illness such as a malignant tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | high adaptive group, low adaptive group, very high adaptive group, very low adaptive group |
Primary outcome
the Assessment of the Psychological Resillience
Time frame: 1 year
Psychological Resillience was evaluated across multiple dimensions, including cognitive functioning, stress coping, psychological well-being, and personality traits, and was measured using internationally accepted scales. Psychological Resillience is measured using the Psychological Resilience Scale (CD-RISC), which consists of 25 items rated on a 5-point Richter's scale, with scores ranging from 0 to 4 indicating that this is not the case at all, seldom the case, sometimes the case, often the case, and almost always the case. The sum of the scores of the items is the total score of the scale, and the total score is 0~100, the larger the score indicates the higher the level of psychological resilience, and the score of less than 60 is the poor level of psychological resilience, 61~69 is the average level of psychological resilience, 70~79 is the good level of psychological resilience, and >=80 is the excellent level of psychological resilience.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 38019467Greenberg RL, Guzick AG, Schneider SC, Weinzimmer SA, Kook M, Perozo Garcia AB, Storch EA. Depressive Symptoms in Autistic Youth with Anxiety Disorders. J Dev Behav Pediatr. 2023 Dec 1;44(9):e597-e603. doi: 10.1097/DBP.0000000000001223. Epub 2023 Oct 11.
- Background: PubMed 38015186Brunette MF, Erlich MD, Edwards ML, Adler DA, Berlant J, Dixon L, First MB, Oslin DW, Siris SG, Talley RM. Addressing the Increasing Mental Health Distress and Mental Illness Among Young Adults in the United States. J Nerv Ment Dis. 2023 Dec 1;211(12):961-967. doi: 10.1097/NMD.0000000000001734.
- Background: PubMed 37967073Wong WLE, Arathimos R, Lewis CM, Young AH, Dawe GS. Investigating the role of the relaxin-3/RXFP3 system in neuropsychiatric disorders and metabolic phenotypes: A candidate gene approach. PLoS One. 2023 Nov 15;18(11):e0294045. doi: 10.1371/journal.pone.0294045. eCollection 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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. This study is not recruiting at the moment.
Guang Zhang, Dr principal investigator
Qianfoshan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Predisposition to Disease and Environment, run by Qianfoshan 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenqi Hu, MPH (15098719908, huwenqi_epi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Assessment of the Psychological Resillience (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06193005, which also lists 3 linked publications.
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 5 Jan 2024.