Clinical trial NCT04413513: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Symptoms
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 48
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: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Attention network test (ANT)
timeFrame: T1: baseline, T2: 4th week, T3:12th week
Secondary outcomes:
measure: Subjective memory complaints (SMC)
timeFrame: T1: baseline, T2: 4th week, T3:12th week
measure: Clinical Dementia Rating (CDR)
timeFrame: T1: baseline, T2: 4th week, T3:12th week
measure: Digit and visual spans
timeFrame: T1: baseline, T2: 4th week, T3:12th week
measure: Delayed recall
timeFrame: T1: baseline, T2: 4th week, T3:12th week
measure: Category verbal fluency tests
timeFrame: T1: baseline, T2: 4th week, T3:12th week
measure: Trail making tests
timeFrame: T1: baseline, T2: 4th week, T3:12th week
measure: Hong Kong - Montreal Cognitive Assessment
timeFrame: T1: baseline, T2: 4th week, T3:12th week
measure: The Chinese Neuropsychiatric Inventory (CNPI)
timeFrame: T1: baseline, T2: 4th week, T3:12th week
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: T1: baseline, T2: 4th week, T3:12th week
measure: Hamilton Depression Scale (HAM-D)
timeFrame: T1: baseline, T2: 4th week, T3:12th week
measure: The Disability Assessment for Dementia (DAD)
timeFrame: T1: baseline, T2: 4th week, T3:12th week
measure: Lifestyle activity participation questionnaire
timeFrame: T1: baseline, T2: 4th week, T3:12th week
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Wai Tung Fung, PhD
role: PRINCIPAL_INVESTIGATOR
References: