DepressionNCT06207279
Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
An observational study of Depression and Insomnia, run by Peking University Sixth Hospital at 1 site in China.
Trial summary
This study, based on preliminary experimental results, literature review, and expert consultations, developed the Attentional Rating Scale (ARS). The aim was to rapidly assess participants' attention and potential influencing factors. The research focused on the scale's reliability and validity among healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Insomnia, Attention Disturbances
- What is being tested?
- rating
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2023to 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Sixty cases of patients diagnosed with Major Depressive Disorder (MDD), ADHD and insomnia disorder separately are recruited from outpatient clinics and hospital wards. Additionally, sixty healthy individuals are recruited from the community as control subjects.
Who may be able to join
- Major Depressive Disorder (MDD) or attention deficit hyperactivity disorder (ADHD) diagnosed according to DSM-5, or Chronic Insomnia Disorder diagnosed according to ICSD-3
- Ages between 18 and 60 years old
- Right-handed
- Educational level ≥5 years or IQ ≥90, capable of understanding and reading Chinese.
Who cannot join
- Currently diagnosed with any other DSM-5 mental disorders (according to MINI 7.0) or ICSD-3 sleep-wake disorders, apart from MDD, ADHD or insomnia disorder
- Currently and past history of neurological disorders and physical illnesses with subjectives
- Consumed alcohol in the week preceding the enrollment
- Using antidepressants, antipsychotics, mood stabilizers, or other central nervous system-acting drugs for at least 4 weeks in the current episode
- Undergoing any physical treatments such as ECT, neuromodulation therapy or Traditional Chinese Medicine treatment in the past 6 months
- Refused to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
Xueqin Wang, MD, +8610-82077885, wangxueqin@bjmu.edu.cn
About this study
This study, based on preliminary experimental results, literature review, and expert consultations, developed the Attentional Rating Scale (ARS). The aim was to rapidly assess participants' attention and potential influencing factors. The research focused on the scale's reliability and validity among healthy adults. Additionally, the Attention Network Test (ANT) served as the gold standard for evaluating attention. The study attempted to identify correlations between various dimensions of attention and the three attentional networks.
Read the detailed description
- To adiministrate 60 healthy subjects to evaluate internal consistency reliability.
- To choose 20 cases for ARS retesting 7 days after the first ARS evaluation.
- To evaluate the split half reliability through the Spearman Brown coefficient.
- To apply principal component analysis for structural validity analysis.
- Using the Attention Network Test (ANT) and Toronto Hospital Alertness Test (THE) as gold standards, the Pearson correlation coefficient was used for criterion validity analysis.
- To administrate 60 patients with MDD, ADHD and insomnia disorder testing the discrimination validity of ARS.
- Conditions
- Depression, Insomnia, Attention Disturbances, Healthy
- Being tested
- rating
- Medical subject headings
- Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ratingDiagnostic test
rating scales, test ANT
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder | Patients meeting the diagnostic criteria for Major Depressive Disorder (MDD) according to DSM-5. Receives: Diagnostic Test: rating | |
| Chronic Insomnia Disorder | Patients meeting the diagnostic criteria for Chronic Insomnia Disorder according to ICSD-3. Receives: Diagnostic Test: rating | |
| Health Control | Healthy population. Receives: Diagnostic Test: rating | |
| Attention Deficit and hyperactivity Disorder | Patients meeting the diagnostic criteria for Attention Deficit and hyperactivity Disorder (ADHD) according to DSM-5. Receives: Diagnostic Test: rating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developing Attention Rating Scale（ARS）
The Attention Assessment Scale is developing as a tool to assess attention ability designed for self-rating scale. Its purpose is to swiftly evaluate the attention levels of adults. There are 30 items in ARS. The minimum value is 1 and maximum value is 5, and the higher scores mean a better outcome for attention ability.
Measured: 3 months
Reliability and Validity of the Attention Assessment Scale.
Reliability
- Cronbach α of ARS should be above 0.8 that means good reliability.
- The intra group correlation value for retesting reliability should be above 0.8 that means good retesting reliability.
Validity
- The split half reliability measured and factor analysis to test constuctive validity of ARS.
- The correlation coefficient r with ANT and the correlation coefficient r with THAT should be statistic significant, that means good validity of attention ability for Attention Assessment Scale.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start28 Sep 2023
- Primary completion31 Dec 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.
- Other trials for DepressionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xueqin Wang, Peking University Sixth Hospital
- Investigators
- Xueqin Wang, doctor, Principal investigator, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207279
- Sponsor's protocol ID
- 2022-056
- Status last verified
- Feb 2024
- First submitted
- 10 Oct 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
- ClinicalTrials.gov ID
- NCT06207279
- Acronym / sponsor ID
- 2022-056
- Conditions
- Depression, Insomnia, Attention Disturbances, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 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.
This study, based on preliminary experimental results, literature review, and expert consultations, developed the Attentional Rating Scale (ARS). The aim was to rapidly assess participants' attention and potential influencing factors. The research focused on the scale's reliability and validity among healthy adults. Additionally, the Attention Network Test (ANT) served as the gold standard for evaluating attention. The study attempted to identify correlations between various dimensions of attention and the three attentional networks.
Detailed description
- To adiministrate 60 healthy subjects to evaluate internal consistency reliability.
- To choose 20 cases for ARS retesting 7 days after the first ARS evaluation.
- To evaluate the split half reliability through the Spearman Brown coefficient.
- To apply principal component analysis for structural validity analysis.
- Using the Attention Network Test (ANT) and Toronto Hospital Alertness Test (THE) as gold standards, the Pearson correlation coefficient was used for criterion validity analysis.
- To administrate 60 patients with MDD, ADHD and insomnia disorder testing the discrimination validity of ARS.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder | – | Diagnostic Test: ratingPatients meeting the diagnostic criteria for Major Depressive Disorder (MDD) according to DSM-5. |
| Chronic Insomnia Disorder | – | Diagnostic Test: ratingPatients meeting the diagnostic criteria for Chronic Insomnia Disorder according to ICSD-3. |
| Health Control | – | Diagnostic Test: ratingHealthy population. |
| Attention Deficit and hyperactivity Disorder | – | Diagnostic Test: ratingPatients meeting the diagnostic criteria for Attention Deficit and hyperactivity Disorder (ADHD) according to DSM-5. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sixty cases of patients diagnosed with Major Depressive Disorder (MDD), ADHD and insomnia disorder separately are recruited from outpatient clinics and hospital wards. Additionally, sixty healthy individuals are recruited from the community as control subjects.
Key inclusion criteria (4 listed)
- Major Depressive Disorder (MDD) or attention deficit hyperactivity disorder (ADHD) diagnosed according to DSM-5, or Chronic Insomnia Disorder diagnosed according to ICSD-3
- Ages between 18 and 60 years old
- Right-handed
- Educational level ≥5 years or IQ ≥90, capable of understanding and reading Chinese.
Key exclusion criteria (6 listed)
- Currently diagnosed with any other DSM-5 mental disorders (according to MINI 7.0) or ICSD-3 sleep-wake disorders, apart from MDD, ADHD or insomnia disorder
- Currently and past history of neurological disorders and physical illnesses with subjectives
- Consumed alcohol in the week preceding the enrollment
- Using antidepressants, antipsychotics, mood stabilizers, or other central nervous system-acting drugs for at least 4 weeks in the current episode
- Undergoing any physical treatments such as ECT, neuromodulation therapy or Traditional Chinese Medicine treatment in the past 6 months
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 |
|---|---|---|
| ratingrating scales, test ANT | Diagnostic test | Attention Deficit and hyperactivity Disorder, Chronic Insomnia Disorder, Health Control, Major Depressive Disorder |
Primary outcome
Developing Attention Rating Scale（ARS）
Time frame: 3 months
The Attention Assessment Scale is developing as a tool to assess attention ability designed for self-rating scale. Its purpose is to swiftly evaluate the attention levels of adults. There are 30 items in ARS. The minimum value is 1 and maximum value is 5, and the higher scores mean a better outcome for attention ability.
Reliability and Validity of the Attention Assessment Scale.
Time frame: 2 years
Reliability 1. Cronbach α of ARS should be above 0.8 that means good reliability. 2. The intra group correlation value for retesting reliability should be above 0.8 that means good retesting reliability. Validity 1. The split half reliability measured and factor analysis to test constuctive validity of ARS. 2. The correlation coefficient r with ANT and the correlation coefficient r with THAT should be statistic significant, that means good validity of attention ability for Attention Assessment Scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Xueqin Wang, doctor principal investigator
Peking University Sixth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Insomnia, run by Peking University Sixth Hospital at 1 site in China.
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 4 inclusion and 6 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Xinyang Zhang, master (+8610-62723770, zhangxinyang2022@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developing Attention Rating Scale（ARS） (time frame: 3 months). 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 28 Feb 2024.