Experimental Study of the Impact of a Group Therapy Psychological Intervention for Caregivers of Alzheimer's Disease Patients (EMOCUIDA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
ClinicalTrials.gov Identifier:
NCT01762618
First received: December 18, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

A randomized controlled trial 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 14 sessions of a cognitive-behavioral psychological group therapy. This study aims to demonstrate that Alzheimer's patients' caregivers can benefit from group counseling, with an improvement in mood state, quality of life, perceived burden and a decrease in anxiety and depression. Two evaluations will be done: before the therapy sessions (basal) and when intervention is finished (final).


Condition Intervention
Psychological Support to Caregivers of Azlheimer's Patients
Behavioral: Cognitive Behavioral Therapy Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Experimental Study of the Impact of a Structured Psychological Intervention Based on Group Therapy for Caregivers of Alzheimer's Patients.

Resource links provided by NLM:


Further study details as provided by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation:

Primary Outcome Measures:
  • Change from baseline in POMS Scale ("Profile of Mood States") [ Time Frame: Pre-treatment and 4 weeks post treatment ] [ Designated as safety issue: No ]
    Change from baseline compared to the control and active arms using the Profile of Mood State (POMS) validated in structure and content for the Spanish language. This scale is a popular instrument for mood evaluation. It comprises 44 items (with a Likert response from 0 to 4), representing six conceptual dimensions: tension, depression,anger, vigour, fatigue and friendliness.


Secondary Outcome Measures:
  • Change from baseline compared to the control and active arms using the Martin and cols. scale to assess the overload level of the family caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia. [ Time Frame: Pre-treatment and 4 weeks post treatment ] [ Designated as safety issue: No ]
    Martin and cols. scale is an adaptation of the Zarit questionnaire to assess the overload level of the caregiver. It is a self administered questionnaire, with 22 items with each item scored from 1 ('none') to 5 (`nearly always').


Other Outcome Measures:
  • Change from baseline compared to the control and active arms using the SF-36 v2 (Short Form-36 Health Survey), a questionnaire that measures the Quality of Life related to Health. [ Time Frame: Pre-treatment and 4 weeks post treatment ] [ Designated as safety issue: No ]
    The SF-36 has 36 items that assesse eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems); bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. This version of the instrument asks for participants to reply to questions according to how they have felt over the previous four weeks. The items use Likert-type scales, some with 3, 5 or 6 points.

  • Change from baseline compared to the control and active arms using the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Pre-treatment and 4 weeks post treatment ] [ Designated as safety issue: No ]
    The HADS is a fourteen item scale with a Likert response from 0 to 3 that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.


Enrollment: 83
Study Start Date: January 2012
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy Group
14 therapy sessions, once a week for one and a half hours.
Behavioral: Cognitive Behavioral Therapy Group
Therapy Groups
Other Name: 14 therapy sessions, once a week for one and a half hours.
No Intervention: Control Group
Social support for caregiver (through the social worker) as usual. The social worker gives information when they considered that there is a social economic risk or upon request by the caregiver.

Detailed Description:

The aim of this study is to conduct group therapy with Alzheimer's caregivers at three centers in the province of Barcelona: Hospital El Carme Badalona, Sanitary Center of Les Corts and Sarrià.

The therapy sessions are conducted by an expert in group therapy (from the sponsor Pasqual Maragall Foundation) and the social worker of each of the centers. The study takes place for four months and consists of weekly therapy sessions of an hour and a half each (14 sessions in total), based on cognitive and behavioral theory. The participants and the control group are evaluated at the beginning and at the end of the study in terms of mood, quality of life, anxiety and depression.

This study aims to demonstrate that Alzheimer's patient's caregivers can benefit from group counseling, resulting in an improvement in their emotional state, perceived burden, quality of life and a more positive attitude coping with the new situation.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To be the principal caregiver of a person with Alzheimer's disease
  • The patient has a possible or probable diagnosis of Alzheimer's disease made for an Accredited Dementia Unit.
  • The patient score in the Global Deterioration Scale must be: 4, 5 or 6A.
  • The caregiver must dedicate at least 5 hours a day or spend a significant part of his time to care-related tasks
  • The caregiver must sign the Informed Consent

Exclusion Criteria:

  • To receive a financial compensation for the care of the patient
  • The caregiver or the patient has a psychiatric illness according to the DSM-IV TR, such that the investigator considers it might hinder the dynamics of the group and affect the objectives of the study
  • Be receiving some type of formal counseling (conducted by a therapist
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762618

Locations
Spain
Hospital del Carme
Badalona, Barcelona, Spain, 0
Primary Assistant Center Les Corts
Barcelona, Catalonia, Spain
Primary Assistant Center Sarrià
Barcelona, Catalonia, Spain
Sponsors and Collaborators
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Investigators
Principal Investigator: Sandra Poudevida, PhD Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
ClinicalTrials.gov Identifier: NCT01762618     History of Changes
Other Study ID Numbers: EMOCUIDA/FPM-0211
Study First Received: December 18, 2012
Last Updated: July 8, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation:
Group Cognitive Behavior Therapy, Alzheimer's disease, Caregivers¡

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014