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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Integrated Attention Training Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IATP<br> | Behavioral: Integrated Attention Training Program<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance - Chinese version of Disability of Assessment in dementia (CDAD) | 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. | 6 weeks after baseline and 6 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subjective cognitive complaints, Attention training