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Completed

NCT Number: NCT06063265

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ada WT FUNG

Hong Kong, China

About this study

This is a 2-armed randomized control trial. For both groups, participants will attend a 45-minute training twice a week for consecutive 6 weeks in a group of 6 people. IATP group (I) will begin with 5 minutes of warm up to give instructions, followed by 5 minutes of breathing exercises, 5 minutes of body scanning, 10 minutes of dual-task training, 15 minutes of functional training, and 5 minutes of performance appraisal under guidance of an intervention instructor. Control group (C) will receive 12 sessions of health education on managing chronic diseases or conditions commonly found in old age during the intervention period.

Assessments will take place at baseline (T0), immediately after intervention (T1) and after 24-week (T2).

Measurement will include a battery of cognitive assessments, Hamilton Anxiety Scale (HAM-A), and a questionnaire on sociodemographic characteristics (age, sex, educational level, and socioeconomic status), physical and mental health statuses, and lifestyle patterns (smoking, drinking, and leisure activities in the past one month). In addition, a 15ml blood sample will be collected from each consenting participant by a phlebotomist for an inflammatory assay analysis at T0. Follow-up assessments and blood collections will be arranged at 6th (T1) and 24th (T2) week.

Linear mixed effects models will analyze the changes on anxiety and cognitive performance from baseline to endpoints. All the analyses will be based on Intention-to-treat principle.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Attention - Digit Span Forward Task

    Time frame: 6 weeks after baseline and 6 months after baseline

    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.

  2. Attention - Chinese Trail Making Test - Part A (CTMT-A)

    Time frame: 6 weeks after baseline and 6 months after baseline

    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

  3. Executive function - Category Verbal Fluency Test (CVFT)

    Time frame: 6 weeks after baseline and 6 months after baseline

    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.

  4. Executive function - Digit Span Backwards Task

    Time frame: 6 weeks after baseline and 6 months after baseline

    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.

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

    Time frame: 6 weeks after baseline and 6 months after baseline

    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. Anxiety symptoms

    Time frame: 6 weeks after baseline and 6 months after baseline

    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.

  7. Level of inflammation

    Time frame: 6 weeks after baseline and 6 months after baseline

    Levels of IL-1β

  8. Level of inflammation

    Time frame: 6 weeks after baseline and 6 months after baseline

    Levels of IL-6

  9. Level of inflammation

    Time frame: 6 weeks after baseline and 6 months after baseline

    Levels of TNF-α

  10. Level of inflammation

    Time frame: 6 weeks after baseline and 6 months after baseline

    Levels of CRP

Secondary outcomes

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

    Time frame: 6 weeks after baseline and 6 months after baseline

    It is subdivided into basic activities of daily living (BADL) and instrumental activities of daily living (IADL). It evaluates the ability of an individual to initiate, plan and execute everyday activities. The overall score of DAD ranges from 0 to 100, with higher score indicating better functioning.

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2023
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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