Alzheimer's Disease
Conditions
Keywords
Family Caregivers, Psychotherapy Group
Brief summary
An experimental study designed to test the effectiveness of a psychological intervention based on group therapy for the caregivers of Alzheimer's disease patients. The intervention consists of 16 sessions of a cognitive-behavioral psychological group therapy. This study aims to demonstrate that Alzheimer's patients' caregivers can decrease the feelings of burden after been involved in a group therapy.
Interventions
BEHAVIORALPsychotherapy groups
BEHAVIORALSelf-help groups
Sponsors
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Main caregiver of an Alzheimer Disease Patient. * Alzheimer Disease Patient with mild/severe cognitive impairment. * High compliance to therapy sessions. * Sign informed consent.
Exclusion criteria
* Low commitment to develop all study phases. * Caregiver activity remunerated. * Caregiver with psychiatric disorders that can affect the development of the sessions. * Caregivers who have received psychological care during last year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview. | 16 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in anxiety and depression from baseline compared to the control and active arms measured by Goldberg Scale. | 4 months and 16 months |
| Descriptive analysis of the caregivers' characteristics (sociodemographics, relation wih the AD patient). | Baseline (0 months) |
| Descriptive analysis of the caregiver's cognition using DEM-DETECT Module 1. | 4 months |
| Change in caregiver burden from baseline compared to the control and active arms measured by Zarit Burden Interview. | 4 months and 16 months |
| Change in quality of life from baseline compared to the control and active arms measured by Casp-19 and SF-36 questionnaires. | 4 months - 16 months |
| Change in resilience from baseline compared to the control and active arms measured by Connor-Davidson Resilience Scale. | 4 months - 16 months |
| Change in functional social support from baseline compared to the control and active arms using Duke-UNC questionnaire. | 4 months - 16 months |
| Preliminary cost-effectiveness analysis related resources needed to caregivers and Alzheimer patients. | 4 months - 16 months |
Countries
Spain
Outcome results
None listed