Efficacy of a Multicomponent Cognitive Intervention in Adults With Subjective Cognitive Decline and Mild Cognitive Impairments
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
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Taipei、台湾
- National Taiwan University Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：multicomponent cognitive intervention
|
The intervention takes place in groups of 6-10 participants and is leaded by one occupational therapist. It includes 16 sessions, 90 minutes each. The first part of each session starts with a 15-minute review of previous homework or relaxation. The second part, which lasts 35 minutes, involves structured training with activity-sheets, board games, role-playing and computerized games. The third part, which lasts 30 minutes, is the lifestyle interventions. The instructor explains the generalization of the previous activities toward daily life, and introduces healthy lifestyles. Through group discussions, the therapist guides participants to develop solutions and strategies for their memory or cognition-related problems and application to daily life. The last 10 minutes are used to suggest homework. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：baseline, 16th, 32nd and 48th week
|
The UPSA-Brief, which consists of 2 subscales (communication and financial), is a useful performance-based functional outcome scale.
It has adequate psychometric properties, predicts residential independence, is sensitive to change, and requires only 10-15 minutes to administer.
|
baseline, 16th, 32nd and 48th week
|
|
Change from Baseline the Activities of Daily Living Questionnaire at 16 weeks, 32 weeks, and 48 weeks
時間枠：baseline, 16th, 32nd and 48th week
|
The Activities of Daily Living Questionnaire (ADLQ) is an informant-based assessment of functional abilities in patients with probable Alzheimer disease and other forms of dementia.
The ADLQ measures functioning in six areas: self-care, household care, employment and recreation, shopping and money, travel, and communication.
|
baseline, 16th, 32nd and 48th week
|
|
Change from Baseline the Contextual Memory Test (CMT) at 16 weeks, 32 weeks, and 48 weeks
時間枠：baseline, 16th, 32nd and 48th week
|
The CMT is used to objectively measure awareness of memory capacity, strategy use and recall in adults with memory dysfunction.
It assess 3 areas of memory including: awareness of memory capacity, recall of line-drawn items, and strategy use.
|
baseline, 16th, 32nd and 48th week
|
|
Change from Baseline the Miami Prospective Memory Test (MPMT) at 16 weeks, 32 weeks, and 48 weeks
時間枠：baseline, 16th, 32nd and 48th week
|
The Miami Prospective Memory Test evaluates time-related and event-related prospective memory ability of older adults.
|
baseline, 16th, 32nd and 48th week
|
|
Change from Baseline the Everyday Memory Questionnaire (EMQ) at 16 weeks, 32 weeks, and 48 weeks
時間枠：baseline, 16th, 32nd and 48th week
|
The Everyday Memory Questionnaire (EMQ) was developed as a subjective measure of memory failure in everyday life.
|
baseline, 16th, 32nd and 48th week
|
|
Change from Baseline the Cognitive Failure Questionnaire (CFQ) at 16 weeks, 32 weeks, and 48 weeks
時間枠：baseline, 16th, 32nd and 48th week
|
The CFQ assesses the frequency with which people experienced cognitive failures in daily life.
|
baseline, 16th, 32nd and 48th week
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from Baseline the Word Sequence Learning Test at 16 weeks, 32 weeks, and 48 weeks
時間枠：baseline, 16th, 32nd and 48th week
|
baseline, 16th, 32nd and 48th week
|
|
Change from Baseline the Wechsler Memory Scale-3rd ed. (WMS-III) Logical Memory (LM) subtest at 16 weeks, 32 weeks, and 48 weeks
時間枠：baseline, 16th, 32nd and 48th week
|
baseline, 16th, 32nd and 48th week
|
|
Change from Baseline the Wechsler Memory Scale-3rd ed. (WMS-III) Family Pictures (FP) subtest at 16 weeks, 32 weeks, and 48 weeks
時間枠：baseline, 16th, 32nd and 48th week
|
baseline, 16th, 32nd and 48th week
|
|
Change from Baseline the Color Trails Test at 16 weeks, 32 weeks, and 48 weeks
時間枠：baseline, 16th, 32nd and 48th week
|
baseline, 16th, 32nd and 48th week
|
|
Change from Baseline the Geriatric Depression Scale-Short Form (GDS-S) at 16 weeks, 32 weeks, and 48 weeks
時間枠：baseline, 16th, 32nd and 48th week
|
baseline, 16th, 32nd and 48th week
|
|
Change from Baseline the State-Trait Anxiety Inventory-Situation (STAI-S) at 16 weeks, 32 weeks, and 48 weeks
時間枠：baseline, 16th, 32nd and 48th week
|
baseline, 16th, 32nd and 48th week
|
協力者と研究者
捜査官
- 主任研究者：Hui-Fen Mao、National Taiwan University Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
multicomponent cognitive interventionの臨床試験
-
University of MinnesotaNational Institute of Mental Health (NIMH)完了精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
-
University of Texas at Austin積極的、募集していない
-
Douglas Mental Health University Institute積極的、募集していない
-
University of MichiganNational Institute on Drug Abuse (NIDA)完了