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

Alzheimer's Disease Clinical Trial

— cuiDem  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418806
• Other study ID #: cuiDem/FBB-0113
• Status: Completed
• Phase: N/A
• First received: February 6, 2015
• Last updated: January 19, 2016
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: September 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• Psychotherapy groups

• Self-help groups

Locations

Country	Name	City	State
Spain	AFA Barcelona	Barcelona
Spain	Centro de día Vitalia	Barcelona
Spain	AFA Burgos	Burgos
Spain	AFA Castellón	Castellón
Spain	AGUAFA	Guadasuar
Spain	AFA Lleida	Lleida
Spain	Centro de envejecimiento saludable	Málaga
Spain	Fundació Ana Ribot	Pallejà
Spain	AVAN	Sabadell
Spain	AFATE	Tenerife
Spain	AFA Terres de l'Ebre	Tortosa

Sponsors (1)

Lead Sponsor	Collaborator
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview.		16 months	No
Secondary	Change in caregiver burden from baseline compared to the control and active arms measured by Zarit Burden Interview.		4 months and 16 months	No
Secondary	Change in anxiety and depression from baseline compared to the control and active arms measured by Goldberg Scale.		4 months and 16 months	No
Secondary	Descriptive analysis of the caregivers' characteristics (sociodemographics, relation wih the AD patient).		Baseline (0 months)	No
Secondary	Descriptive analysis of the caregiver's cognition using DEM-DETECT Module 1.		4 months	No
Secondary	Preliminary cost-effectiveness analysis related resources needed to caregivers and Alzheimer patients.		4 months - 16 months	No
Secondary	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	No
Secondary	Change in resilience from baseline compared to the control and active arms measured by Connor-Davidson Resilience Scale.		4 months - 16 months	No
Secondary	Change in functional social support from baseline compared to the control and active arms using Duke-UNC questionnaire.		4 months - 16 months	No

External Links

•   BarcelonaBeta Brain Research Center website