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

January 19, 2016 updated by: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapy group with follow up sessions
Weekly psychotherapy groups during 4 months with a monthly follow up period (12 months)
Behavioral: Psychotherapy groups
Experimental: Therapy group without follow up sessions
Weekly psychotherapy groups during 4 months
Behavioral: Psychotherapy groups
Active Comparator: Active comparator group
Weekly self-help groups during 4 months with a monthly follow up period (12 months)
Behavioral: Self-help groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview.
Time Frame: 16 months
16 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in caregiver burden from baseline compared to the control and active arms measured by Zarit Burden Interview.
Time Frame: 4 months and 16 months
4 months and 16 months
Change in anxiety and depression from baseline compared to the control and active arms measured by Goldberg Scale.
Time Frame: 4 months and 16 months
4 months and 16 months
Descriptive analysis of the caregivers' characteristics (sociodemographics, relation wih the AD patient).
Time Frame: Baseline (0 months)
Baseline (0 months)
Descriptive analysis of the caregiver's cognition using DEM-DETECT Module 1.
Time Frame: 4 months
4 months
Preliminary cost-effectiveness analysis related resources needed to caregivers and Alzheimer patients.
Time Frame: 4 months - 16 months
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.
Time Frame: 4 months - 16 months
4 months - 16 months
Change in resilience from baseline compared to the control and active arms measured by Connor-Davidson Resilience Scale.
Time Frame: 4 months - 16 months
4 months - 16 months
Change in functional social support from baseline compared to the control and active arms using Duke-UNC questionnaire.
Time Frame: 4 months - 16 months
4 months - 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Investigators

  • Principal Investigator: Sandra Poudevida, Psychologist, BarcelonaBeta Brain Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cuiDem/FBB-0113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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