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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06063265
• Other study ID #: HMRF 10211426
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Older adults aged 60 to 90 years;

2. No Major Neurocognitive Disorders

3. Presence of anxiety symptoms

4. Presence of Subjective Cognitive Complaints

Exclusion Criteria:

1. Clinical dementia

2. History of major depression

3. Presence of major neurological deficit

4. Presence of severe visual impairment; or

5. Currently on any psychotropic or other medications known to affect cognition; or

6. Participation in other cognitive trainings or interventions 6 months prior to this study or during the study period.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Integrated Attention Training Program
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.

Locations

Country	Name	City	State
China	Ada WT FUNG	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Level of inflammation	Levels of IL-1ß	6 weeks after baseline and 6 months after baseline
Primary	Level of inflammation	Levels of IL-6	6 weeks after baseline and 6 months after baseline
Primary	Level of inflammation	Levels of TNF-a	6 weeks after baseline and 6 months after baseline
Primary	Level of inflammation	Levels of CRP	6 weeks after baseline and 6 months after baseline
Secondary	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