Effect of IATP on Cognitive Functioning in Anxious Older Adults.

NCT04413513 | Completed

• 1 other identifier: 1-BE11
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Subjective memory complaints (SMC)

  T1: baseline, T2: 4th week, T3:12th week

• Clinical Dementia Rating (CDR)

  T1: baseline, T2: 4th week, T3:12th week

• Digit and visual spans

  T1: baseline, T2: 4th week, T3:12th week

• Delayed recall

  T1: baseline, T2: 4th week, T3:12th week

• Category verbal fluency tests

  T1: baseline, T2: 4th week, T3:12th week

Study Arms (2)

Integrated Attention Training Program

EXPERIMENTAL

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)

Health Education

PLACEBO COMPARATOR

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

Interventions

Integrated Attention Training Program (IATP) OTHER

Integrated attention training program (IATP) is a newly developed cognitive training programs that combined relaxation technique with integrated attentional training into daily life activity.

Integrated Attention Training Program

Health Education OTHER

Health educational sessions on health concerns and physical diseases commonly found in old age

Health Education

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adults aged 60 - 90 years; and
• Presence of subjective memory complaints as measured by memory inventory for the Chinese; and
• Anxiety symptoms as measured by Hamilton Anxiety Scale (HAM-A) with a score of 18 or above (indicated as mild anxiety symptoms).

You may not qualify if:

• 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;
• Clinical dementia rating larger than or equal to 0.5; or
• Clinically depressed as assessed by Hamilton Depression Rating Scale with a score of 20 or higher; or
• Past history of major depressive episode, bipolar affective disorders or psychosis; or
• Physical frailty that may affect attendance to training sessions; or
• Currently on psychotropic or other medications know to affect cognition (e.g., benzodiazepines, anti-dementia medication, etc.); or
• Participants in other cognitive training or intervention for brain health during the study period; or
• Presence of major neurological deficit including history of stroke, transient ischemic attack or traumatic brain injury; or
• Significant communicative impairment.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Wai Tung Fung, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: June 4, 2020
• Study Start: August 13, 2018
• Primary Completion: December 31, 2018
• Study Completion: January 7, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)