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

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Status: Completed

Conditions: Psychological Support to Caregivers of Azlheimer's Patients

Treatments: Behavioral: Cognitive Behavioral Therapy Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01762618

EMOCUIDA/FPM-0211

Details and patient eligibility

About

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).

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

83 participants in 2 patient groups

Cognitive Behavioral Therapy Group

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Therapy Group

Control Group

No Intervention group

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.