NCT06207279

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

October 10, 2023

Last Update Submit

February 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    3 months

  • Reliability and Validity of the Attention Assessment Scale.

    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.

    2 years

Study Arms (4)

Major Depressive Disorder

Patients meeting the diagnostic criteria for Major Depressive Disorder (MDD) according to DSM-5.

Diagnostic Test: rating

Chronic Insomnia Disorder

Patients meeting the diagnostic criteria for Chronic Insomnia Disorder according to ICSD-3.

Diagnostic Test: rating

Health Control

Healthy population.

Diagnostic Test: rating

Attention Deficit and hyperactivity Disorder

Patients meeting the diagnostic criteria for Attention Deficit and hyperactivity Disorder (ADHD) according to DSM-5.

Diagnostic Test: rating

Interventions

ratingDIAGNOSTIC_TEST

rating scales, test ANT

Attention Deficit and hyperactivity DisorderChronic Insomnia DisorderHealth ControlMajor Depressive Disorder

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

DepressionSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Xueqin Wang, doctor

    Peking University Sixth Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyang Zhang, master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 10, 2023

First Posted

January 16, 2024

Study Start

September 28, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations