Clinical trial NCT01762618: Experimental Study of the Impact of a Group Therapy Psychological Intervention for Caregivers of Alzheimer's Disease Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Support to Caregivers of Azlheimer's Patients
Keywords: Group Cognitive Behavior Therapy, Alzheimer's disease, Caregivers¡
Lead sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline in POMS Scale ("Profile of Mood States")
timeFrame: Pre-treatment and 4 weeks post treatment
Secondary outcomes:
measure: 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.
timeFrame: Pre-treatment and 4 weeks post treatment
Other outcomes:
measure: 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.
timeFrame: Pre-treatment and 4 weeks post treatment
measure: Change from baseline compared to the control and active arms using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Pre-treatment and 4 weeks post treatment
Locations:
city: Badalona
country: Spain
facility: Hospital del Carme
state: Barcelona
city: Barcelona
country: Spain
facility: Primary Assistant Center Les Corts
state: Catalonia
city: Barcelona
country: Spain
facility: Primary Assistant Center Sarrià
state: Catalonia
Study officials:
affiliation: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
name: Sandra Poudevida, PhD
role: PRINCIPAL_INVESTIGATOR
References: