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Cognitive-Behavioral Treatment for Mild Alzheimer's Patients and Their Caregivers (CBTAC)

2017년 11월 1일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (실제)

50

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 스위스
      • Zurich, 스위스, 8032
        • Psychiatric University Hospital, Clinic for Geriatric Medicine

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

50년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Cognitive Behavioral Therapy (CBT)
Comprehensive, CBT-based, multi-component treatment. Comprehensive CBT intervention in addition to standard treatment
행동: Comprehensive, CBT-based, multi-component 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).
다른 이름들:
  • 심리 사회적 개입
활성 비교기: Treatment as usual (TAU)
Standard Treatment (medical and psychosocial)
행동: Treatment as usual
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.
다른 이름들:
  • 표준 처리

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Change from baseline in Geriatric Depression Scale (GDS)
기간: 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

2차 결과 측정

결과 측정
기간
Change from baseline in Neuropsychiatric Inventory (NPI)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Zurich

협력자

Psychiatric University Hospital, Zurich

수사관

  • 수석 연구원: Simon Forstmeier, Ph.D., University of Zurich
  • 연구 의자: Andreas Maercker, M.D.,Ph.D., University of Zurich
  • 연구 의자: Egemen Savaskan, M.D., Psychiatric University Hospital, Zurich
  • 연구 의자: Tanja Roth, Ph.D., Psychiatric University Hospital, Zurich

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 2월 1일

기본 완료 (실제)

2017년 9월 1일

연구 완료 (실제)

2017년 9월 1일

연구 등록 날짜

최초 제출

2011년 1월 3일

QC 기준을 충족하는 최초 제출

2011년 1월 7일

처음 게시됨 (추정)

2011년 1월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 11월 1일

마지막으로 확인됨

2017년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 10-130034/1a

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