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

NCT ID: NCT06063265

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-06-30

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

IATP

Group Type: EXPERIMENTAL

Integrated Attention Training Program

Intervention Type: BEHAVIORAL

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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hong Kong Baptist University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ada WT FUNG, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Baptist University

Locations

Ada WT FUNG

Hong Kong, , China

Countries

China

Other Identifiers

HMRF 10211426

Identifier Type: -

Identifier Source: org_study_id