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

Not Applicable

Completed

• Conditions: Alzheimer's Disease
• Interventions: Behavioral: Psychotherapy groups; Behavioral: Self-help groups

• Registration Number: NCT02418806
• Lead Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-07
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-16
• Study Completion: 2015-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapy group without follow up sessions	Psychotherapy groups	Weekly psychotherapy groups during 4 months
Active comparator group	Self-help groups	Weekly self-help groups during 4 months with a monthly follow up period (12 months)
Therapy group with follow up sessions	Psychotherapy groups	Weekly psychotherapy groups during 4 months with a monthly follow up period (12 months)

Primary Outcome Measures

Name	Time	Method
Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview.	16 months

Secondary Outcome Measures

Name	Time	Method
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)
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
Descriptive analysis of the caregiver's cognition using DEM-DETECT Module 1.	4 months

Trial Locations

Locations (11)

AFA Burgos; 🇪🇸 Burgos, Spain

AFA Castellón; 🇪🇸 Castellón, Spain

AFA Lleida; 🇪🇸 Lleida, Spain

AFA Barcelona; 🇪🇸 Barcelona, Spain

Centro de envejecimiento saludable; 🇪🇸 Málaga, Spain

AFA Terres de l'Ebre; 🇪🇸 Tortosa, Spain

Centro de día Vitalia; 🇪🇸 Barcelona, Spain

AVAN; 🇪🇸 Sabadell, Spain

AGUAFA; 🇪🇸 Guadasuar, Spain

AFATE; 🇪🇸 Tenerife, Spain

Fundació Ana Ribot; 🇪🇸 Pallejà, Spain