Clinical trial NCT01273272: Cognitive-Behavioral Treatment for Mild Alzheimer's Patients and Their Caregivers
Official title: Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Cognitive Behavior Therapy
Early dementia, Alzheimer type
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Psychiatric University Hospital, Zurich
First posted: 2011-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Geriatric Depression Scale (GDS)
timeFrame: Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Secondary outcomes:
measure: Change from baseline in Neuropsychiatric Inventory (NPI)
timeFrame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
measure: Change from baseline in Bayer-Activities of Daily Living (B-ADL)
timeFrame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
measure: Change from baseline in Stress Coping Inventory (SCI)
timeFrame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
measure: Change from baseline in Apathy Evaluation Scale (AES)
timeFrame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
measure: Caregiver: Change from baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
measure: Caregiver: Change from baseline in Trait scale of the State Trait Anxiety Inventory (STAI)
timeFrame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
measure: Caregiver: Change from baseline in Anger-in and anger-out scales of the State Trait Anger Expression Inventory (STAXI)
timeFrame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
measure: Caregiver: Change from baseline in Short-Form Health Survey (SF-12)
timeFrame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
measure: Caregiver: Change from baseline in Zarit Burden Interview (ZBI)
timeFrame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
measure: Caregiver: Change from baseline in Stress Coping Inventory (SCI)
timeFrame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Psychiatric University Hospital, Clinic for Geriatric Medicine
Study officials:
affiliation: University of Zurich
name: Simon Forstmeier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Andreas Maercker, M.D.,Ph.D.
role: STUDY_CHAIR
affiliation: Psychiatric University Hospital, Zurich
name: Egemen Savaskan, M.D.
role: STUDY_CHAIR
affiliation: Psychiatric University Hospital, Zurich
name: Tanja Roth, Ph.D.
role: STUDY_CHAIR
References:
citation: Forstmeier S, Maercker A. Problems of aging. Psychotherapy in older age [German]. Göttingen, Germany: Hogrefe. 2008.
citation: Forstmeier S, Maercker A. Psychotherapie im Alter. Psychotherapeutenjournal 4: 340-352, 2007
citation: 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.