Effect of IATP on Cognitive Functioning in Anxious Older Adults.

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.

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Symptoms
• Intervention / Treatment: Other: Integrated Attention Training Program (IATP); Other: Health Education

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

1. To examine the cognitive effect of 4 week integrated attention training program (I) and health education (C) in older adults with anxiety symptoms.
2. To examine the 4 week integrated attention training program (I) and health education (C) in alleviating mood symptoms in older adults with anxiety symptoms.
3. To examine the acceptability and adherence of the proposed intervention.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated Attention Training Program; 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.	Other: Integrated Attention Training Program (IATP); Integrated attention training program (IATP) is a newly developed cognitive training programs that combined relaxation technique with integrated attentional training into daily life activity.
Placebo Comparator: Health Education; The control group (C) will receive health educational sessions on health concerns and physical diseases commonly found in old age during the invention period.	Other: Health Education; Health educational sessions on health concerns and physical diseases commonly found in old age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	T1: baseline, T2: 4th week, T3:12th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	T1: baseline, T2: 4th week, T3:12th week
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)	T1: baseline, T2: 4th week, T3:12th week
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	T1: baseline, T2: 4th week, T3:12th week
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.	T1: baseline, T2: 4th week, T3:12th week
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.	T1: baseline, T2: 4th week, T3:12th week
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.	T1: baseline, T2: 4th week, T3:12th week
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	T1: baseline, T2: 4th week, T3:12th week
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.	T1: baseline, T2: 4th week, T3:12th week
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.	T1: baseline, T2: 4th week, T3:12th week
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.	T1: baseline, T2: 4th week, T3:12th week
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.	T1: baseline, T2: 4th week, T3:12th week
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.	T1: baseline, T2: 4th week, T3:12th week

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Wai Tung Fung, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): January 7, 2019

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 1-BE11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No