Effect of a Six-week Integrated Attention Training Program on the Cognitive Functions of Older Adults With Co-occurring Anxiety Symptoms and Subjective Cognitive Complaints

NCT06063265 | Completed DMC

• 1 other identifier: HMRF 10211426
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single-blind randomized control trial is to compare a 6-week Integrated Attention Training Program (IATP) and health education in older people with co-occurrence of anxiety symptoms and subjective cognitive decline (SCC). The study aims to answer if a 6-week Integrated Attention Training Program (IATP) will improve cognitive, anxiety, and level of pro-inflammatory biomarkers in this high-risk group. Older adults with co-occurring anxiety and SCC will be recruited to participate in a 6-week single-blind randomized controlled trial. IATP group (Intervention group) will undergo attention and functional training. Control group will receive health education. Investigators will compare the IATP with health education to see if cognitive function, anxiety symptoms, and level of pro-inflammatory biomarkers in comparison to health education will improved after intervention and over 24 weeks.

Conditions

Anxiety

Keywords

Subjective cognitive complaints; Attention training

Outcome Measures

Primary Outcomes (10)

• Attention - Digit Span Forward Task

  Participants are asked to repeat a series of digits immediately after presentation, in ascending order starting from 3 and up to 8 digits. Analysis of scoring is based on the span length achieved.

  6 weeks after baseline and 6 months after baseline

• Attention - Chinese Trail Making Test - Part A (CTMT-A)

  The participant will need to connect between Arabic and Chinese numbers in sequential order. The completion time (in second) and the numbers of errors made during the test are recorded

  6 weeks after baseline and 6 months after baseline

• Executive function - Category Verbal Fluency Test (CVFT)

  It is test of semantic fluency and executive function. Participants were asked to generate as many exemplars as possible for each of the three semantic categories, namely animals, fruits, and vegetables, in 60 seconds. Their responses were recorded in serial order. Analysis of scoring is based on the total number of words that the participant is able to produce across all three categories.

  6 weeks after baseline and 6 months after baseline

• Executive function - Digit Span Backwards Task

  Participants will be asked to repeat a series of digits immediately after presentation, in reverse order starting from 2 and up to 8 digits. Analysis of scoring is based on the span length achieved.

  6 weeks after baseline and 6 months after baseline

• Executive function - Chinese Trail Making Test - Part B (CTMT-B)

  The participant will need to connect and alternate between Arabic and Chinese numbers. The completion time (in second) and the numbers of errors made during the test are recorded.

  6 weeks after baseline and 6 months after baseline

• Anxiety symptoms

  Hamilton Anxiety Scale (HAM-A) - each item will be scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where 17 or less indicates a mild severity, 18-24 indicates a mild to moderate severity and 25-30 a moderate to severe severity.

  6 weeks after baseline and 6 months after baseline

• Level of inflammation

  Levels of IL-1β

  6 weeks after baseline and 6 months after baseline

• Level of inflammation

  Levels of IL-6

  6 weeks after baseline and 6 months after baseline

• Level of inflammation

  Levels of TNF-α

  6 weeks after baseline and 6 months after baseline

• Level of inflammation

  Levels of CRP

  6 weeks after baseline and 6 months after baseline

Secondary Outcomes (1)

• Functional performance - Chinese version of Disability of Assessment in dementia (CDAD)

  6 weeks after baseline and 6 months after baseline

Study Arms (2)

IATP

EXPERIMENTAL

Behavioral: Integrated Attention Training Program

Control

NO INTERVENTION

Interventions

Integrated Attention Training Program BEHAVIORAL

Integrated Attention Training Program (IATP) specifically aims at training attentional control, which involves the coordination of complex behaviours, such as planning, reasoning, selection and information inhibition.

IATP

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adults aged 60 to 90 years;
• No Major Neurocognitive Disorders
• Presence of anxiety symptoms
• Presence of Subjective Cognitive Complaints

You may not qualify if:

• Clinical dementia
• History of major depression
• Presence of major neurological deficit
• Presence of severe visual impairment; or
• Currently on any psychotropic or other medications known to affect cognition; or
• Participation in other cognitive trainings or interventions 6 months prior to this study or during the study period.

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

Ada WT FUNG

Hong Kong, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ada WT FUNG, PhD

  Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: October 2, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 4, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)