Clinical trial NCT04023032: Efficacy of a Multicomponent Cognitive Intervention in Adults With Subjective Cognitive Decline and Mild Cognitive Impairments
Official title: Efficacy of a Multicomponent Cognitive Intervention Program on the Cognitive and Daily Function in Adults With Subjective Cognitive Decline and Mild Cognitive Impairments: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Subjective Cognitive Decline
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Individuals with mild cognitive impairment (MCI) and subjective cognitive decline (SCD) have greater risk of developing dementia. Cognitive intervention is a topic of great interest in individuals with MCI and SCD for the purpose of preventing or delaying the occurrence of dementia. There are many different types of cognitive interventions, which aim to positively impact the cognitive functioning of an individual and have been classified as cognitive stimulation, cognitive training, and cognitive rehabilitation. However, most studies used neuropsychological cognitive measures for outcome evaluation. The impact of cognitive interventions on daily functional performance among individuals with MCI and SCD were rarely explored. In addition, cognitive training focusing on specific cognitive outcomes is suspected to have limited far transfer to everyday measures. Therefore, a multicomponent intervention which integrates several types of intervention is recommended to reach the maximum impact on daily function.

The purposes of this study are to examine the effects of a multicomponent cognitive intervention on cognitive and daily functional outcomes in individuals with MCI and SCD, and to compare the effects between the two groups. In addition, the investigators will also investigate whether the demographic (e.g., age and educational level, etc.) and clinical variables (e.g., duration of cognitive complains, level of depression and baseline cognitive function, etc.) may affect the outcomes of cognitive intervention.

Detailed description: This study is a pretest-posttest design. Thirty-five subjects with MCI and 35 with SCD, who are diagnosed by physicians, will be recruited from the neurology outpatient clinic of National Taiwan University Hospital. All participants will wait for 16 weeks as a historical control and then receive the multicomponent cognitive intervention. The intervention is composed of 14 weekly 1.5-hour group sessions and 2 individual sessions in a 4-month period.

The multicomponent cognitive intervention in this study is a combination of several approaches, including cognitive training, cognitive rehabilitation, lifestyle interventions, and psychological interventions. Cognitive training is an approach which trains patients by repeated practicing to optimize or restore cognitive functions. Cognitive rehabilitation is tailored programs in which therapist usually provides patient strategies focusing on specific activities of daily life. Lifestyle interventions educate and encourage individuals to make changes to their life to balance the risk and protective factors. The strategies can include regular physical exercise, healthy nutrition (i.e., Mediterranean diet), frequent participation in cognitively-stimulating activities, and reduction of smoking and heavy alcohol consumption. Psychological interventions target neuropsychiatric symptoms that are common among individuals with SCD and MCI (e.g., depression, anxiety, fatigue, poor sleep) and thus include relaxation exercises, mindfulness techniques, skills to manage stress and poor sleep, and cognitive behavioral techniques. By using the approaches above together, the investigators hope to improve participants' cognitive and daily function.

All participants will be assessed at four time points: before waiting period (A0), before the intervention (A1), right after the 16-week intervention (A2), and 16 weeks after the intervention (A3). The primary outcomes are the subjective and objective performance of activities of daily living, and the secondary outcomes are the cognitive performance on the neurological tests, anxiety, and depression.

Eligibility criteria: Inclusion Criteria:

* over 50 years old
* years of education \> 6
* mild cognitive impairment or subjective cognitive decline diagnosed by physician
* the Barthel Index scored 100
* the Montreal Cognitive Assessment (MoCA) \> 18
* the UPSA-Brief \> 50

Exclusion Criteria:

* without concurrent major or significant psychiatric disorders
* severe physical diseases which might affect cognitive functions
* difficult to follow instructions due to visual or hearing impairments

Primary outcomes:
measure: Change from Baseline the Brief University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA-Brief ) (Traditional Chinese Version) at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
measure: Change from Baseline the Activities of Daily Living Questionnaire at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
measure: Change from Baseline the Contextual Memory Test (CMT) at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
measure: Change from Baseline the Miami Prospective Memory Test (MPMT) at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
measure: Change from Baseline the Everyday Memory Questionnaire (EMQ) at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
measure: Change from Baseline the Cognitive Failure Questionnaire (CFQ) at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
Secondary outcomes:
measure: Change from Baseline the Word Sequence Learning Test at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
measure: Change from Baseline the Wechsler Memory Scale-3rd ed. (WMS-III) Logical Memory (LM) subtest at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
measure: Change from Baseline the Wechsler Memory Scale-3rd ed. (WMS-III) Family Pictures (FP) subtest at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
measure: Change from Baseline the Color Trails Test at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
measure: Change from Baseline the Geriatric Depression Scale-Short Form (GDS-S) at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
measure: Change from Baseline the State-Trait Anxiety Inventory-Situation (STAI-S) at 16 weeks, 32 weeks, and 48 weeks
timeFrame: baseline, 16th, 32nd and 48th week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Hui-Fen Mao
role: PRINCIPAL_INVESTIGATOR
References: