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

July 8, 2014 updated by: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Experimental Study of the Impact of a Structured Psychological Intervention Based on Group Therapy for Caregivers of Alzheimer's Patients.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

83

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
      • Badalona, Barcelona, Spain
        • Hospital del Carme
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Primary Assistant Center Les Corts
      • Barcelona, Catalonia, Spain
        • Primary Assistant Center Sarrià

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 to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in POMS Scale ("Profile of Mood States")
Time Frame: Pre-treatment and 4 weeks post treatment
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.
Pre-treatment and 4 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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').
Pre-treatment and 4 weeks post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Pre-treatment and 4 weeks post treatment
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
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.
Pre-treatment and 4 weeks post treatment

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, PhD, Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

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, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

January 4, 2013

First Posted (Estimate)

January 8, 2013

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMOCUIDA/FPM-0211

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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