Clinical trial NCT06063265: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: Subjective cognitive complaints
Attention training
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Attention - Digit Span Forward Task
timeFrame: 6 weeks after baseline and 6 months after baseline
measure: Attention - Chinese Trail Making Test - Part A (CTMT-A)
timeFrame: 6 weeks after baseline and 6 months after baseline
measure: Executive function - Category Verbal Fluency Test (CVFT)
timeFrame: 6 weeks after baseline and 6 months after baseline
measure: Executive function - Digit Span Backwards Task
timeFrame: 6 weeks after baseline and 6 months after baseline
measure: Executive function - Chinese Trail Making Test - Part B (CTMT-B)
timeFrame: 6 weeks after baseline and 6 months after baseline
measure: Anxiety symptoms
timeFrame: 6 weeks after baseline and 6 months after baseline
measure: Level of inflammation
timeFrame: 6 weeks after baseline and 6 months after baseline
measure: Level of inflammation
timeFrame: 6 weeks after baseline and 6 months after baseline
measure: Level of inflammation
timeFrame: 6 weeks after baseline and 6 months after baseline
measure: Level of inflammation
timeFrame: 6 weeks after baseline and 6 months after baseline
Secondary outcomes:
measure: Functional performance - Chinese version of Disability of Assessment in dementia (CDAD)
timeFrame: 6 weeks after baseline and 6 months after baseline
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Ada WT FUNG
Study officials:
affiliation: Hong Kong Baptist University
name: Ada WT FUNG, PhD
role: PRINCIPAL_INVESTIGATOR
References: