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

NCT02418806 — Not applicable, Completed, 231 participants, Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

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Registry	NCT02418806, acronym cuiDem
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	231 (Actual)
Sponsor	Barcelonabeta Brain Research Center, Pasqual Maragall Foundation (Other)
Conditions	Alzheimer's Disease
Interventions	Psychotherapy groups, Self-help groups (Behavioral)
Dates	start 2014-01-01, primary completion 2014-07-01, completion 2015-09-01, first posted 2015-04-16, last updated 2016-01-20
Locations	11 sites in Spain

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Therapy group with follow up sessions	Experimental	Behavioral: Psychotherapy groups	Weekly psychotherapy groups during 4 months with a monthly follow up period (12 months)
Therapy group without follow up sessions	Experimental	Behavioral: Psychotherapy groups	Weekly psychotherapy groups during 4 months
Active comparator group	Active comparator	Behavioral: Self-help groups	Weekly self-help groups during 4 months with a monthly follow up period (12 months)

Psychotherapy groups (Behavioral)
Self-help groups (Behavioral)

+Outcome measures

Primary outcomes

Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview. [16 months]

Secondary outcomes

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 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]

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (11)

Facility	City	Country
AFA Barcelona	Barcelona	Spain
Centro de día Vitalia	Barcelona	Spain
AFA Burgos	Burgos	Spain
AFA Castellón	Castellon	Spain
AGUAFA	Guadassuar	Spain
AFA Lleida	Lleida	Spain
Centro de envejecimiento saludable	Málaga	Spain
Fundació Ana Ribot	Pallejà	Spain
AVAN	Sabadell	Spain
AFATE	Santa Cruz de Tenerife	Spain
AFA Terres de l'Ebre	Tortosa	Spain

+Investigators

Sandra Poudevida, Psychologist, Principal investigator, BarcelonaBeta Brain Research Center