Cognitive-Behavioral Treatment for Mild Alzheimer's Patients and Their Caregivers (CBTAC)
1. november 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Zurich, Schweiz, 8032
- Psychiatric University Hospital, Clinic for Geriatric Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 95 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Cognitive Behavioral Therapy (CBT)
Comprehensive, CBT-based, multi-component treatment.
Comprehensive CBT intervention in addition to standard treatment
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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).
Andre navne:
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Aktiv komparator: Treatment as usual (TAU)
Standard Treatment (medical and psychosocial)
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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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline in Geriatric Depression Scale (GDS)
Tidsramme: Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline in Neuropsychiatric Inventory (NPI)
Tidsramme: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Change from baseline in Bayer-Activities of Daily Living (B-ADL)
Tidsramme: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Change from baseline in Stress Coping Inventory (SCI)
Tidsramme: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Change from baseline in Apathy Evaluation Scale (AES)
Tidsramme: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
Tidsramme: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Trait scale of the State Trait Anxiety Inventory (STAI)
Tidsramme: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Anger-in and anger-out scales of the State Trait Anger Expression Inventory (STAXI)
Tidsramme: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Short-Form Health Survey (SF-12)
Tidsramme: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Zarit Burden Interview (ZBI)
Tidsramme: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Stress Coping Inventory (SCI)
Tidsramme: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Simon Forstmeier, Ph.D., University of Zurich
- Studiestol: Andreas Maercker, M.D.,Ph.D., University of Zurich
- Studiestol: Egemen Savaskan, M.D., Psychiatric University Hospital, Zurich
- Studiestol: Tanja Roth, Ph.D., Psychiatric University Hospital, Zurich
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2011
Primær færdiggørelse (Faktiske)
1. september 2017
Studieafslutning (Faktiske)
1. september 2017
Datoer for studieregistrering
Først indsendt
3. januar 2011
Først indsendt, der opfyldte QC-kriterier
7. januar 2011
Først opslået (Skøn)
10. januar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. november 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. november 2017
Sidst verificeret
1. november 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10-130034/1a
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .