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Effect of IATP on Cognitive Functioning in Anxious Older Adults.

Primary Purpose

Anxiety Symptoms

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Integrated Attention Training Program (IATP)
Health Education
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Symptoms

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Older adults aged 60 - 90 years; and
  2. Presence of subjective memory complaints as measured by memory inventory for the Chinese; and
  3. Anxiety symptoms as measured by Hamilton Anxiety Scale (HAM-A) with a score of 18 or above (indicated as mild anxiety symptoms).

Exclusion Criteria:

  1. DSM-5 diagnosis of either Major Neurocognitive Disorder due to AD, or Major Vascular Neurocognitive Disorder with small vessel disease. This would include satisfying criteria for significant cognitive decline in at least one of six areas of cognition (memory, perceptual-motor, complex attention, language, executive function and social cognition), and with clinical or neuroimaging features indicative of either AD or small vessel disease; or;
  2. Clinical dementia rating larger than or equal to 0.5; or
  3. Clinically depressed as assessed by Hamilton Depression Rating Scale with a score of 20 or higher; or
  4. Past history of major depressive episode, bipolar affective disorders or psychosis; or
  5. Physical frailty that may affect attendance to training sessions; or
  6. Currently on psychotropic or other medications know to affect cognition (e.g., benzodiazepines, anti-dementia medication, etc.); or
  7. Participants in other cognitive training or intervention for brain health during the study period; or
  8. Presence of major neurological deficit including history of stroke, transient ischemic attack or traumatic brain injury; or
  9. Significant communicative impairment.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Integrated Attention Training Program

Health Education

Arm Description

The intervention group (I) will receive "integrated attention training program (IATP)" on a variety of structured attention tasks by an intervention instructor. It is considered to be simple and safe but effective enough for cognitive health promotion.

The control group (C) will receive health educational sessions on health concerns and physical diseases commonly found in old age during the invention period.

Outcomes

Primary Outcome Measures

Attention network test (ANT)
ANT will measure the changes in attention from baseline to endpoint between the intervention and control groups. Performance was based on (i) accuracy refers to the degree of correctness and also to quality control, which means that if the participant's accuracy fell below 70%, the case would be considered unqualified. (2) reaction time refers to the processing speed. Median values of RT will be used as raw scores to avoid the influence of outliers. The indices will be served to compare the effect of IATP and health education.

Secondary Outcome Measures

Subjective memory complaints (SMC)
SMC will be measured by Memory Inventory for the Chinese (MIC-27). It is locally validated among older people with mild cognitive impairment (MCI) and mild dementia. Participants with a positive answer to any of the 27 questions will be categorized as having SCC at baseline. The total score ranges from 0 to 27, with higher marks indicating poor self-efficacy in memory. There is no cut-off for this outcome measure.
Clinical Dementia Rating (CDR)
CDR is a semi-structured clinical interview for the severity of cognitive impairment rated along six dimensions of cognition and function, including memory, orientation, judgement and problem solving, community affairs, home, hobbies and personal cares. Scores in each dimension are combined to form a global rating ranging from 0 (not demented), 0.5 (questionable), 1 (mild), 2 (moderate) to 3 (severe dementia). It has been demonstrated that CDR sum of boxes is sensitive to capture early functional changes in the preclinical phase of AD (CDR 0.5)
Digit and visual spans
Digit span is a test of attention and verbal working memory. Participants are asked to repeat back a series of digits immediately after presentation, in ascending order starting from 3 and up to 8 digits (i.e., forward), and in reverse order beginning from 2 to 8 digits (i.e., backward). Both trials of each span length are administered until failure on both trials of a span length is obtained. Visual span is a test of attention and visual working memory. It measures the ability to reproduce the spatial pattern of tapping sequences on an array of blocks beginning with 2 and going up to 8 blocks plus the ability to reverse the spatial block tapping sequence from 2 up to 7 blocks. Similar to digit span test, both trails of a span length are given until the length reached at which both are failed. Changes in digit and visual spans from baseline to endpoint between groups will be served to compare the effect of IATP and health education on executive function
Delayed recall
Changes in delayed recall from baseline to endpoint between the intervention and control groups will be served to compare the effect of IATP and health education on episodic memory.
Category verbal fluency tests
Category verbal fluency test (CVFT) 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. Also, the number of repetitions and intrusions were recorde. Changes in category verbal fluency test from baseline to endpoint between the intervention and control groups were served to compare the effect of IATP and health education on verbal memory.
Trail making tests
Chinese trail making test (A and B) is a test providing information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. There are two parts to the Chinese trail test: A, in which the subject needs to connect the Arabic numbers in sequential order, and B, in which the subject alternates between Arabic and Chinese numbers to suit the literacy of local older population. The completion time (in second) and the numbers of errors made during the test are recorded. Changes in trail making test from baseline to endpoint between the intervention and control groups will be served to compare the effect of IATP and health education on executive function and processing speed.
Hong Kong - Montreal Cognitive Assessment
Changes in Hong Kong - Montreal Cognitive Assessment (HK-MoCA) from baseline to endpoint between the intervention and control groups will be served to compare the effect of IATP and health education on global cognition. The score ranges from 0-30. A HK-MoCA score of 26 or above, which has been used as a cut-off for mild cognitive impairment (MCI) in older people aged 65 or above with more than 10 years of education
The Chinese Neuropsychiatric Inventory (CNPI)
The Chinese Neuropsychiatric Inventory (CNPI) would be used to assess changes in 12 neuropsychiatric symptoms. The frequency of each symptom is rated on a scale of 1 (occasionally) to 4 (very frequently). The severity of each symptom is also rated on a scale of 1 to 3. The total score for each domain is calculated by multiplying the frequency by the severity. A total score is calculated by adding all the domain scores together. Higher score indicating more neuropsychiatric disturbances, In the current proposal, CNPI would evaluate potential mood and behavioral changes.
Hamilton Anxiety Scale (HAM-A)
Hamilton Anxiety Scale (HAM-A). It will be used to evaluate anxiety symptoms from baseline to endpoint in both groups. It consists of 14 items on different anxiety symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where 17 or less indicates mild severity, 18-24 indicates mild to moderate severity and 25-30 moderate to severe.
Hamilton Depression Scale (HAM-D)
Hamilton Depression Scale (HAM-D). It is a commonly used scale to evaluate depressive symptoms. It consists of 17 items on different depressive symptoms, a score of 20 and higher is considered as moderate depression.
The Disability Assessment for Dementia (DAD)
The Disability Assessment for Dementia (DAD) captures the ability of a subject to perform everyday tasks appropriate for the older community. It assesses functional abilities in both basic and instrumental activities of daily living.It measures different dimensions (expressed in 0-100%) of task performance, including initiation, planning and organization, and effectiveness. Changes in each dimension of the activities of daily living (ADL) were evaluated to compare the effect of IATP and health education on daily functioning.
Lifestyle activity participation questionnaire
Lifestyle activities were categorized into four different types: (i) physical exercises (including mind body exercise and strenuous exercise); (ii) cognitive activity; (iii) social activity; and (iv) recreational activity. The total number of activities engaged was counted for each category. Frequency of lifestyle activity participation was defined as the number of times the participants had engaged at a specified interval in the past year: (i) daily; (ii) several times a week; (iii) weekly; (iv) several times a month; (v) monthly; (vi) bimonthly; and (vii) 3 months or longer. Lifestyle activity participation to measure the change of activity pattern before and after the intervention.

Full Information

First Posted
August 13, 2018
Last Updated
May 28, 2020
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT04413513
Brief Title
Effect of IATP on Cognitive Functioning in Anxious Older Adults.
Official Title
A Pilot Study on Randomized Control Trial Comparing Integrated Attention Training Program (IATP) and Health Education on Preservation of Cognitive Functioning in Chinese Older Adults With Anxiety Symptoms.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
January 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Older adults with anxiety symptoms was found to be associated with greater risk of dementia. Interventions targeting signs as early as in the pre-symptomatic phase could be most effective in early prevention of dementia. On reviewing the identified non-pharmacological interventions, integrated attention training program (IATP) is proposed to target older adults with anxiety symptoms in Hong Kong.
Detailed Description
Older adults with anxiety disorders or symptoms are not in the consideration of management for dementia prevention. However, the condition is found to be associated with profound negative subsequent decline on both functioning and cognition. While epidemiological studies reported high prevalence in older population, its symptoms are often overlooked in the presence of other age-related diseases in the community as well as among the health professionals. It is expected that cognitive and functional disabilities secondary to this condition will pose a significant burden to the existing healthcare system. Therefore, targeting anxious older adults for early intervention may help to cut healthcare costs and to ensure proactive dementia prevention in the long run. The current proposed intervention intends to attenuate the trajectory of cognitive decline at a very early stage and enhance existing cognitive function to delay the onset of dementia. This study aims to explore whether the use of integrated attention training program (IATP) could improve cognitive performance and functioning in older adults with anxiety symptoms. In particulars, we aim To examine the cognitive effect of 4 week integrated attention training program (I) and health education (C) in older adults with anxiety symptoms. To examine the 4 week integrated attention training program (I) and health education (C) in alleviating mood symptoms in older adults with anxiety symptoms. To examine the acceptability and adherence of the proposed intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Attention Training Program
Arm Type
Experimental
Arm Description
The intervention group (I) will receive "integrated attention training program (IATP)" on a variety of structured attention tasks by an intervention instructor. It is considered to be simple and safe but effective enough for cognitive health promotion.
Arm Title
Health Education
Arm Type
Placebo Comparator
Arm Description
The control group (C) will receive health educational sessions on health concerns and physical diseases commonly found in old age during the invention period.
Intervention Type
Other
Intervention Name(s)
Integrated Attention Training Program (IATP)
Intervention Description
Integrated attention training program (IATP) is a newly developed cognitive training programs that combined relaxation technique with integrated attentional training into daily life activity.
Intervention Type
Other
Intervention Name(s)
Health Education
Intervention Description
Health educational sessions on health concerns and physical diseases commonly found in old age
Primary Outcome Measure Information:
Title
Attention network test (ANT)
Description
ANT will measure the changes in attention from baseline to endpoint between the intervention and control groups. Performance was based on (i) accuracy refers to the degree of correctness and also to quality control, which means that if the participant's accuracy fell below 70%, the case would be considered unqualified. (2) reaction time refers to the processing speed. Median values of RT will be used as raw scores to avoid the influence of outliers. The indices will be served to compare the effect of IATP and health education.
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Secondary Outcome Measure Information:
Title
Subjective memory complaints (SMC)
Description
SMC will be measured by Memory Inventory for the Chinese (MIC-27). It is locally validated among older people with mild cognitive impairment (MCI) and mild dementia. Participants with a positive answer to any of the 27 questions will be categorized as having SCC at baseline. The total score ranges from 0 to 27, with higher marks indicating poor self-efficacy in memory. There is no cut-off for this outcome measure.
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Title
Clinical Dementia Rating (CDR)
Description
CDR is a semi-structured clinical interview for the severity of cognitive impairment rated along six dimensions of cognition and function, including memory, orientation, judgement and problem solving, community affairs, home, hobbies and personal cares. Scores in each dimension are combined to form a global rating ranging from 0 (not demented), 0.5 (questionable), 1 (mild), 2 (moderate) to 3 (severe dementia). It has been demonstrated that CDR sum of boxes is sensitive to capture early functional changes in the preclinical phase of AD (CDR 0.5)
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Title
Digit and visual spans
Description
Digit span is a test of attention and verbal working memory. Participants are asked to repeat back a series of digits immediately after presentation, in ascending order starting from 3 and up to 8 digits (i.e., forward), and in reverse order beginning from 2 to 8 digits (i.e., backward). Both trials of each span length are administered until failure on both trials of a span length is obtained. Visual span is a test of attention and visual working memory. It measures the ability to reproduce the spatial pattern of tapping sequences on an array of blocks beginning with 2 and going up to 8 blocks plus the ability to reverse the spatial block tapping sequence from 2 up to 7 blocks. Similar to digit span test, both trails of a span length are given until the length reached at which both are failed. Changes in digit and visual spans from baseline to endpoint between groups will be served to compare the effect of IATP and health education on executive function
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Title
Delayed recall
Description
Changes in delayed recall from baseline to endpoint between the intervention and control groups will be served to compare the effect of IATP and health education on episodic memory.
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Title
Category verbal fluency tests
Description
Category verbal fluency test (CVFT) 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. Also, the number of repetitions and intrusions were recorde. Changes in category verbal fluency test from baseline to endpoint between the intervention and control groups were served to compare the effect of IATP and health education on verbal memory.
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Title
Trail making tests
Description
Chinese trail making test (A and B) is a test providing information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. There are two parts to the Chinese trail test: A, in which the subject needs to connect the Arabic numbers in sequential order, and B, in which the subject alternates between Arabic and Chinese numbers to suit the literacy of local older population. The completion time (in second) and the numbers of errors made during the test are recorded. Changes in trail making test from baseline to endpoint between the intervention and control groups will be served to compare the effect of IATP and health education on executive function and processing speed.
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Title
Hong Kong - Montreal Cognitive Assessment
Description
Changes in Hong Kong - Montreal Cognitive Assessment (HK-MoCA) from baseline to endpoint between the intervention and control groups will be served to compare the effect of IATP and health education on global cognition. The score ranges from 0-30. A HK-MoCA score of 26 or above, which has been used as a cut-off for mild cognitive impairment (MCI) in older people aged 65 or above with more than 10 years of education
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Title
The Chinese Neuropsychiatric Inventory (CNPI)
Description
The Chinese Neuropsychiatric Inventory (CNPI) would be used to assess changes in 12 neuropsychiatric symptoms. The frequency of each symptom is rated on a scale of 1 (occasionally) to 4 (very frequently). The severity of each symptom is also rated on a scale of 1 to 3. The total score for each domain is calculated by multiplying the frequency by the severity. A total score is calculated by adding all the domain scores together. Higher score indicating more neuropsychiatric disturbances, In the current proposal, CNPI would evaluate potential mood and behavioral changes.
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Title
Hamilton Anxiety Scale (HAM-A)
Description
Hamilton Anxiety Scale (HAM-A). It will be used to evaluate anxiety symptoms from baseline to endpoint in both groups. It consists of 14 items on different anxiety symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where 17 or less indicates mild severity, 18-24 indicates mild to moderate severity and 25-30 moderate to severe.
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Title
Hamilton Depression Scale (HAM-D)
Description
Hamilton Depression Scale (HAM-D). It is a commonly used scale to evaluate depressive symptoms. It consists of 17 items on different depressive symptoms, a score of 20 and higher is considered as moderate depression.
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Title
The Disability Assessment for Dementia (DAD)
Description
The Disability Assessment for Dementia (DAD) captures the ability of a subject to perform everyday tasks appropriate for the older community. It assesses functional abilities in both basic and instrumental activities of daily living.It measures different dimensions (expressed in 0-100%) of task performance, including initiation, planning and organization, and effectiveness. Changes in each dimension of the activities of daily living (ADL) were evaluated to compare the effect of IATP and health education on daily functioning.
Time Frame
T1: baseline, T2: 4th week, T3:12th week
Title
Lifestyle activity participation questionnaire
Description
Lifestyle activities were categorized into four different types: (i) physical exercises (including mind body exercise and strenuous exercise); (ii) cognitive activity; (iii) social activity; and (iv) recreational activity. The total number of activities engaged was counted for each category. Frequency of lifestyle activity participation was defined as the number of times the participants had engaged at a specified interval in the past year: (i) daily; (ii) several times a week; (iii) weekly; (iv) several times a month; (v) monthly; (vi) bimonthly; and (vii) 3 months or longer. Lifestyle activity participation to measure the change of activity pattern before and after the intervention.
Time Frame
T1: baseline, T2: 4th week, T3:12th week

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 - 90 years; and Presence of subjective memory complaints as measured by memory inventory for the Chinese; and Anxiety symptoms as measured by Hamilton Anxiety Scale (HAM-A) with a score of 18 or above (indicated as mild anxiety symptoms). Exclusion Criteria: DSM-5 diagnosis of either Major Neurocognitive Disorder due to AD, or Major Vascular Neurocognitive Disorder with small vessel disease. This would include satisfying criteria for significant cognitive decline in at least one of six areas of cognition (memory, perceptual-motor, complex attention, language, executive function and social cognition), and with clinical or neuroimaging features indicative of either AD or small vessel disease; or; Clinical dementia rating larger than or equal to 0.5; or Clinically depressed as assessed by Hamilton Depression Rating Scale with a score of 20 or higher; or Past history of major depressive episode, bipolar affective disorders or psychosis; or Physical frailty that may affect attendance to training sessions; or Currently on psychotropic or other medications know to affect cognition (e.g., benzodiazepines, anti-dementia medication, etc.); or Participants in other cognitive training or intervention for brain health during the study period; or Presence of major neurological deficit including history of stroke, transient ischemic attack or traumatic brain injury; or Significant communicative impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Tung Fung, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of IATP on Cognitive Functioning in Anxious Older Adults.

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