Cognitive-Behavioral Treatment for Mild Alzheimer's Patients and Their Caregivers (CBTAC)
2017年11月1日 更新者：Simon Forstmeier、University of Zurich
Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial
The purpose of this study is to determine whether a comprehensive cognitive-behavioral therapy-based, multi-component treatment programme is effective in the treatment of neuropsychiatric symptoms of patients with mild Alzheimer's dementia.
調査の概要
状態
完了
条件
詳細な説明
Mild Alzheimer's dementia (AD) cases are with 15 millions worldwide the largest fraction of all AD cases. Most patients are cared for by their family at home. Neuropsychiatric symptoms are very common in AD, even as early as in mild AD: About 90% of all mild AD cases experience neuropsychiatric symptoms, most frequently depression, anxiety, and irritability. These symptoms are associated with greater morbidity, reduced quality of life for the patient, increased burden and depression for the caregiver, higher costs of care, and nursing home placement. Thus, interventions aimed at treating these symptoms could have a tremendous effect on pa-tients, caregivers, and society.
This study is a randomized, controlled trial (RCT) evaluating a comprehensive CBT-based, multi-component treatment programme consisting of eight modules (diagnosis and goal-setting; psycho-education; engagement in pleasant activities; cognitive restructuring; life review; training caregiver in behavior management techniques; interventions for the caregiver; couples counseling) and 20 sessions.
This trial aims at significantly reducing depressive and other neuropsychiatric symptoms in the AD patients, and secondary in reducing burden and depressive symptoms of the caregivers. Patients with AD alone or mixed AD and vascular dementia that are in the mild stage and suffer under any neuropsychiatric symptom will be included. The patients and their caregiver will be randomized to either the CBT-based intervention or to the control condition that receives treatment as usual (TAU).
研究の種類
介入
入学 (実際)
50
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Zurich、スイス、8032
- Psychiatric University Hospital, Clinic for Geriatric Medicine
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年～95年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients have to meet NINCDS-ADRDA criteria for probable or possible AD (McKhann et al., 1984). Mixed Alzheimer and Vascular dementia cases will also be included.
- Only AD cases with a mild dementia severity will be included, determined by the Clinical Dementia Rating (CDR) scale (i.e. scores of 0.5 or 1, Morris, 1993) and by the Mini Mental State Examination (MMSE) (i.e. scores of 20 or more, Folstein, Folstein, & McHugh, 1975).
- The patient must suffer under any non-cognitive symptom that motivates him to accept psy-chotherapeutic help.
- A caregiver must be available to take part in most of the therapy sessions.
Exclusion Criteria:
- concomitant alcohol or drug addiction and a history of a malignant disease, severe organ failure, metabolic or hematologic disorders, neurosurgery or neurological condition such as Parkinson's disease, epilepsy, postencephalitic and postconcussional syndrome
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Cognitive Behavioral Therapy (CBT)
Comprehensive, CBT-based, multi-component treatment.
Comprehensive CBT intervention in addition to standard treatment
|
It includes eight modules: diagnosis and goal setting; psychoeducation; engagement in pleasant activities; cognitive restructuring; live review; training caregiver in behavior man-agement techniques; interventions for the caregiver; and couples counselling.
It consists of 20 weekly sessions (plus appr.
5 single session with caregiver).
他の名前：
|
|
アクティブコンパレータ：Treatment as usual (TAU)
Standard Treatment (medical and psychosocial)
|
Each patient/caregiver must receive at least three out of six interventions: (1) psychoeducation on dementia and treatment of dementia (oral and written); (2) appropriate medical treatment; (3) social counseling by specialized staff; (4) memory training in group setting; (5) self-help group for the patient; (6) self-help group for the caregiver.
他の名前：
|
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 |
時間枠 |
|---|---|
|
Change from baseline in Geriatric Depression Scale (GDS)
時間枠：Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from baseline in Neuropsychiatric Inventory (NPI)
時間枠：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
|
Change from baseline in Bayer-Activities of Daily Living (B-ADL)
時間枠：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
|
Change from baseline in Stress Coping Inventory (SCI)
時間枠：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
|
Change from baseline in Apathy Evaluation Scale (AES)
時間枠：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
|
Caregiver: Change from baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
時間枠：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
|
Caregiver: Change from baseline in Trait scale of the State Trait Anxiety Inventory (STAI)
時間枠：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
|
Caregiver: Change from baseline in Anger-in and anger-out scales of the State Trait Anger Expression Inventory (STAXI)
時間枠：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
|
Caregiver: Change from baseline in Short-Form Health Survey (SF-12)
時間枠：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
|
Caregiver: Change from baseline in Zarit Burden Interview (ZBI)
時間枠：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
|
Caregiver: Change from baseline in Stress Coping Inventory (SCI)
時間枠：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Simon Forstmeier, Ph.D.、University of Zurich
- スタディチェア：Andreas Maercker, M.D.,Ph.D.、University of Zurich
- スタディチェア：Egemen Savaskan, M.D.、Psychiatric University Hospital, Zurich
- スタディチェア：Tanja Roth, Ph.D.、Psychiatric University Hospital, Zurich
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Forstmeier S, Maercker A. Problems of aging. Psychotherapy in older age [German]. Göttingen, Germany: Hogrefe. 2008.
- Forstmeier S, Maercker A. Psychotherapie im Alter. Psychotherapeutenjournal 4: 340-352, 2007
- Forstmeier S, Maercker A, Savaskan E, Roth T. Cognitive behavioural treatment for mild Alzheimer's patients and their caregivers (CBTAC): study protocol for a randomized controlled trial. Trials. 2015 Nov 17;16:526. doi: 10.1186/s13063-015-1043-0.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年2月1日
一次修了 (実際)
2017年9月1日
研究の完了 (実際)
2017年9月1日
試験登録日
最初に提出
2011年1月3日
QC基準を満たした最初の提出物
2011年1月7日
最初の投稿 (見積もり)
2011年1月10日
学習記録の更新
投稿された最後の更新 (実際)
2017年11月6日
QC基準を満たした最後の更新が送信されました
2017年11月1日
最終確認日
2017年11月1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。