- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418806
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
-
-
-
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)
|
|
Experimental: Therapy group without follow up sessions
Weekly psychotherapy groups during 4 months
|
|
Active Comparator: Active comparator group
Weekly self-help groups during 4 months with a monthly follow up period (12 months)
|
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.
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.
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.
Clinical Trials on Alzheimer's Disease
-
University of Southern CaliforniaAlzheimer's Therapeutic Research Institute; American Heart Association; Schaeffer...RecruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
-
University of Southern CaliforniaNational Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Brigham and Women's Hospital and other collaboratorsActive, not recruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
University Hospital, BordeauxMinistry for Health and Solidarity, FranceCompletedAlzheimer's Disease (AD) | Alzheimer's Disease (AD) Related DisordersFrance
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease | Normal CognitionUnited States
-
University of Colorado, DenverNational Institute on Aging (NIA)Active, not recruitingSuspected Typical Alzheimer's Disease (AD) | Suspected Atypical Alzheimer's Disease (AD)United States
Clinical Trials on Psychotherapy groups
-
Boston UniversityWorld VisionCompleted
-
Food for the HungryJohns Hopkins University; Teachers College, Columbia UniversityCompletedDepression, Postpartum | Malnutrition, ChildUganda
-
Hannover Medical SchoolUnknownPTSD | Somatoform Disorders | Psychiatric DisorderGermany
-
Tulane University School of Social WorkUnited States Agency for International Development (USAID)CompletedStress, Psychological | Adolescent Behavior | Risk Reduction Behavior
-
Necmettin Erbakan UniversityCompleted
-
Assistance Publique - Hôpitaux de ParisNational Research Agency, FranceCompletedRheumatoid Arthritis | Uveitis | Vasculitis | Type 1 Diabetes | Crohn's Disease | Myositis | Healthy Volunteer | Ankylosing Spondylitis | FMF | Systemic Lupus Erythematosus/Antiphospholipid Syndrome | Cryopyrin-Associated Periodic Syndromes /TNF-receptor Associated Periodic Syndrome | Ulcerative Rectocolitis | Unclassified...France
-
Universidade Federal do Rio de JaneiroCompleted
-
Gazi UniversityCompletedGingival Recession
-
Seventh Medical Center of PLA General HospitalActive, not recruiting
-
Hasan Kalyoncu UniversityCompleted