Clinical trial NCT06207279: Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Official title: Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Insomnia
Attention Disturbances
Healthy
Lead sponsor: Peking University Sixth Hospital
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: 1. To adiministrate 60 healthy subjects to evaluate internal consistency reliability.
2. To choose 20 cases for ARS retesting 7 days after the first ARS evaluation.
3. To evaluate the split half reliability through the Spearman Brown coefficient.
4. To apply principal component analysis for structural validity analysis.
5. 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.
6. To administrate 60 patients with MDD, ADHD and insomnia disorder testing the discrimination validity of ARS.

Eligibility criteria: Inclusion Criteria:

1. Major Depressive Disorder (MDD) or attention deficit hyperactivity disorder (ADHD) diagnosed according to DSM-5, or Chronic Insomnia Disorder diagnosed according to ICSD-3
2. Ages between 18 and 60 years old
3. Right-handed
4. Educational level ≥5 years or IQ ≥90, capable of understanding and reading Chinese.

Exclusion Criteria:

1. 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
2. Currently and past history of neurological disorders and physical illnesses with subjectives
3. Consumed alcohol in the week preceding the enrollment
4. Using antidepressants, antipsychotics, mood stabilizers, or other central nervous system-acting drugs for at least 4 weeks in the current episode
5. Undergoing any physical treatments such as ECT, neuromodulation therapy or Traditional Chinese Medicine treatment in the past 6 months
6. Refused to sign the informed consent form

Primary outcomes:
measure: Developing Attention Rating Scale（ARS）
timeFrame: 3 months
measure: Reliability and Validity of the Attention Assessment Scale.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
Study officials:
affiliation: Peking University Sixth Hospital
name: Xueqin Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References: