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

Primary Purpose

Psychological Support to Caregivers of Azlheimer's Patients

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy Group

About this trial

This is an interventional supportive care trial for Psychological Support to Caregivers of Azlheimer's Patients focused on measuring Group Cognitive Behavior Therapy, Alzheimer's disease, Caregivers¡

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hospital del Carme
Primary Assistant Center Les Corts
Primary Assistant Center Sarrià

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy Group

Control Group

Arm Description

14 therapy sessions, once a week for one and a half hours.

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.

Outcomes

Primary Outcome Measures

Change from baseline in POMS Scale ("Profile of Mood States")

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.

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').

Full Information

NCT ID

NCT01762618

First Posted

December 18, 2012

Last Updated

July 8, 2014

Sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01762618

Brief Title

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

Acronym

EMOCUIDA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

July 2013 (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

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychological Support to Caregivers of Azlheimer's Patients

Keywords

Group Cognitive Behavior Therapy, Alzheimer's disease, Caregivers¡

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Behavioral Therapy Group

Arm Type

Experimental

Arm Description

14 therapy sessions, once a week for one and a half hours.

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy Group

Other Intervention Name(s)

14 therapy sessions, once a week for one and a half hours.

Intervention Description

Therapy Groups

Primary Outcome Measure Information:

Title

Change from baseline in POMS Scale ("Profile of Mood States")

Description

Time Frame

Pre-treatment and 4 weeks post treatment

Secondary Outcome Measure Information:

Title

Description

Time Frame

Pre-treatment and 4 weeks post treatment

Other Pre-specified Outcome Measures:

Title

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.

Description

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.

Time Frame

Pre-treatment and 4 weeks post treatment

Title

Change from baseline compared to the control and active arms using the Hospital Anxiety and Depression Scale (HADS)

Description

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.

Time Frame

Pre-treatment and 4 weeks post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandra Poudevida, PhD

Organizational Affiliation

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital del Carme

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

Country

Spain

Facility Name

Primary Assistant Center Les Corts

City

Barcelona

State/Province

Catalonia

Country

Spain

Facility Name

Primary Assistant Center Sarrià

City

Barcelona

State/Province

Catalonia

Country

Spain

12. IPD Sharing Statement

Links:

URL

http://www.fpmaragall.org

Description

Links to Pasqual Maragall Foundation Web page

Learn more about this trial

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

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