Clinical trial NCT02418806: Group Therapy for Caregivers of Alzheimer's Disease Patients in Spanish Elderly Persons Centres
Official title: Group Therapy for Caregivers of Alzheimer's Disease Patients in Spanish Elderly Persons Centres
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Family Caregivers
Psychotherapy Group
Lead sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview.
timeFrame: 16 months
Secondary outcomes:
measure: Change in caregiver burden from baseline compared to the control and active arms measured by Zarit Burden Interview.
timeFrame: 4 months and 16 months
measure: Change in anxiety and depression from baseline compared to the control and active arms measured by Goldberg Scale.
timeFrame: 4 months and 16 months
measure: Descriptive analysis of the caregivers' characteristics (sociodemographics, relation wih the AD patient).
timeFrame: Baseline (0 months)
measure: Descriptive analysis of the caregiver's cognition using DEM-DETECT Module 1.
timeFrame: 4 months
measure: Preliminary cost-effectiveness analysis related resources needed to caregivers and Alzheimer patients.
timeFrame: 4 months - 16 months
measure: Change in quality of life from baseline compared to the control and active arms measured by Casp-19 and SF-36 questionnaires.
timeFrame: 4 months - 16 months
measure: Change in resilience from baseline compared to the control and active arms measured by Connor-Davidson Resilience Scale.
timeFrame: 4 months - 16 months
measure: Change in functional social support from baseline compared to the control and active arms using Duke-UNC questionnaire.
timeFrame: 4 months - 16 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: AFA Barcelona
city: Barcelona
country: Spain
facility: Centro de día Vitalia
city: Burgos
country: Spain
facility: AFA Burgos
city: Castellón
country: Spain
facility: AFA Castellón
city: Guadasuar
country: Spain
facility: AGUAFA
city: Lleida
country: Spain
facility: AFA Lleida
city: Málaga
country: Spain
facility: Centro de envejecimiento saludable
city: Pallejà
country: Spain
facility: Fundació Ana Ribot
city: Sabadell
country: Spain
facility: AVAN
city: Tenerife
country: Spain
facility: AFATE
city: Tortosa
country: Spain
facility: AFA Terres de l'Ebre
Study officials:
affiliation: BarcelonaBeta Brain Research Center
name: Sandra Poudevida, Psychologist
role: PRINCIPAL_INVESTIGATOR
References: