Group Therapy for Caregivers of Alzheimer's Disease Patients in Spanish Elderly Persons Centres

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation11 sites in 1 country231 target enrollmentJanuary 2014

ConditionsAlzheimer's Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Enrollment: 231
Locations: 11
Primary Endpoint: Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

September 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview.

Time Frame: 16 months

Secondary Outcomes

Change in resilience from baseline compared to the control and active arms measured by Connor-Davidson Resilience Scale.(4 months - 16 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 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)
Preliminary cost-effectiveness analysis related resources needed to caregivers and Alzheimer patients.(4 months - 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 functional social support from baseline compared to the control and active arms using Duke-UNC questionnaire.(4 months - 16 months)