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
Primary Purpose
Anxiety
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Integrated Attention Training Program
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety focused on measuring Subjective cognitive complaints, Attention training
Eligibility Criteria
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.
Sites / Locations
- Ada WT FUNG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
IATP
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
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
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.
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.
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.
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.
Level of inflammation
Levels of IL-1β
Level of inflammation
Levels of IL-6
Level of inflammation
Levels of TNF-α
Level of inflammation
Levels of CRP
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT06063265
First Posted
August 29, 2023
Last Updated
September 26, 2023
Sponsor
Hong Kong Baptist University
1. Study Identification
Unique Protocol Identification Number
NCT06063265
Brief Title
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
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hong Kong Baptist University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Subjective cognitive complaints, Attention training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IATP
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Integrated Attention Training Program
Intervention Description
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 Outcome Measure Information:
Title
Attention - Digit Span Forward Task
Description
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.
Time Frame
6 weeks after baseline and 6 months after baseline
Title
Attention - Chinese Trail Making Test - Part A (CTMT-A)
Description
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
Time Frame
6 weeks after baseline and 6 months after baseline
Title
Executive function - Category Verbal Fluency Test (CVFT)
Description
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.
Time Frame
6 weeks after baseline and 6 months after baseline
Title
Executive function - Digit Span Backwards Task
Description
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.
Time Frame
6 weeks after baseline and 6 months after baseline
Title
Executive function - Chinese Trail Making Test - Part B (CTMT-B)
Description
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.
Time Frame
6 weeks after baseline and 6 months after baseline
Title
Anxiety symptoms
Description
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.
Time Frame
6 weeks after baseline and 6 months after baseline
Title
Level of inflammation
Description
Levels of IL-1β
Time Frame
6 weeks after baseline and 6 months after baseline
Title
Level of inflammation
Description
Levels of IL-6
Time Frame
6 weeks after baseline and 6 months after baseline
Title
Level of inflammation
Description
Levels of TNF-α
Time Frame
6 weeks after baseline and 6 months after baseline
Title
Level of inflammation
Description
Levels of CRP
Time Frame
6 weeks after baseline and 6 months after baseline
Secondary Outcome Measure Information:
Title
Functional performance - Chinese version of Disability of Assessment in dementia (CDAD)
Description
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.
Time Frame
6 weeks after baseline and 6 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ada WT FUNG, PhD
Organizational Affiliation
Hong Kong Baptist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ada WT FUNG
City
Hong Kong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Dissimination through conference presentation and publications
Learn more about this trial
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
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