Group Therapy for Caregivers of Alzheimer's Disease Patients in Spanish Elderly Persons Centres (cuiDem)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychotherapy groups
Self-help groups
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Family Caregivers, Psychotherapy Group
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.
Sites / Locations
- AFA Barcelona
- Centro de día Vitalia
- AFA Burgos
- AFA Castellón
- AGUAFA
- AFA Lleida
- Centro de envejecimiento saludable
- Fundació Ana Ribot
- AVAN
- AFATE
- AFA Terres de l'Ebre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Therapy group with follow up sessions
Therapy group without follow up sessions
Active comparator group
Arm Description
Weekly psychotherapy groups during 4 months with a monthly follow up period (12 months)
Weekly psychotherapy groups during 4 months
Weekly self-help groups during 4 months with a monthly follow up period (12 months)
Outcomes
Primary Outcome Measures
Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview.
Secondary Outcome Measures
Change in caregiver burden from baseline compared to the control and active arms measured by Zarit Burden Interview.
Change in anxiety and depression from baseline compared to the control and active arms measured by Goldberg Scale.
Descriptive analysis of the caregivers' characteristics (sociodemographics, relation wih the AD patient).
Descriptive analysis of the caregiver's cognition using DEM-DETECT Module 1.
Preliminary cost-effectiveness analysis related resources needed to caregivers and Alzheimer patients.
Change in quality of life from baseline compared to the control and active arms measured by Casp-19 and SF-36 questionnaires.
Change in resilience from baseline compared to the control and active arms measured by Connor-Davidson Resilience Scale.
Change in functional social support from baseline compared to the control and active arms using Duke-UNC questionnaire.
Full Information
NCT ID
NCT02418806
First Posted
February 6, 2015
Last Updated
January 19, 2016
Sponsor
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02418806
Brief Title
Group Therapy for Caregivers of Alzheimer's Disease Patients in Spanish Elderly Persons Centres
Acronym
cuiDem
Official Title
Group Therapy for Caregivers of Alzheimer's Disease Patients in Spanish Elderly Persons Centres
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Family Caregivers, Psychotherapy Group
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
231 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapy group with follow up sessions
Arm Type
Experimental
Arm Description
Weekly psychotherapy groups during 4 months with a monthly follow up period (12 months)
Arm Title
Therapy group without follow up sessions
Arm Type
Experimental
Arm Description
Weekly psychotherapy groups during 4 months
Arm Title
Active comparator group
Arm Type
Active Comparator
Arm Description
Weekly self-help groups during 4 months with a monthly follow up period (12 months)
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy groups
Intervention Type
Behavioral
Intervention Name(s)
Self-help groups
Primary Outcome Measure Information:
Title
Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview.
Time Frame
16 months
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Descriptive analysis of the caregivers' characteristics (sociodemographics, relation wih the AD patient).
Time Frame
Baseline (0 months)
Title
Descriptive analysis of the caregiver's cognition using DEM-DETECT Module 1.
Time Frame
4 months
Title
Preliminary cost-effectiveness analysis related resources needed to caregivers and Alzheimer patients.
Time Frame
4 months - 16 months
Title
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
Title
Change in resilience from baseline compared to the control and active arms measured by Connor-Davidson Resilience Scale.
Time Frame
4 months - 16 months
Title
Change in functional social support from baseline compared to the control and active arms using Duke-UNC questionnaire.
Time Frame
4 months - 16 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Poudevida, Psychologist
Organizational Affiliation
BarcelonaBeta Brain Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
AFA Barcelona
City
Barcelona
Country
Spain
Facility Name
Centro de día Vitalia
City
Barcelona
Country
Spain
Facility Name
AFA Burgos
City
Burgos
Country
Spain
Facility Name
AFA Castellón
City
Castellón
Country
Spain
Facility Name
AGUAFA
City
Guadasuar
Country
Spain
Facility Name
AFA Lleida
City
Lleida
Country
Spain
Facility Name
Centro de envejecimiento saludable
City
Málaga
Country
Spain
Facility Name
Fundació Ana Ribot
City
Pallejà
Country
Spain
Facility Name
AVAN
City
Sabadell
Country
Spain
Facility Name
AFATE
City
Tenerife
Country
Spain
Facility Name
AFA Terres de l'Ebre
City
Tortosa
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://fpmaragall.org/
Description
Pasqual Maragall Foundation website
URL
http://www.barcelonabeta.org/
Description
BarcelonaBeta Brain Research Center website
Learn more about this trial
Group Therapy for Caregivers of Alzheimer's Disease Patients in Spanish Elderly Persons Centres
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