Experimental Study of the Impact of a Group Therapy Psychological Intervention for Caregivers of Alzheimer's Disease Patients (EMOCUIDA)
|ClinicalTrials.gov Identifier: NCT01762618|
Recruitment Status : Completed
First Posted : January 8, 2013
Last Update Posted : July 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Psychological Support to Caregivers of Azlheimer's Patients||Behavioral: Cognitive Behavioral Therapy Group||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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.|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||July 2013|
U.S. FDA Resources
Experimental: Cognitive Behavioral Therapy Group
14 therapy sessions, once a week for one and a half hours.
Behavioral: Cognitive Behavioral Therapy Group
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.
- 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.
- 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').
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762618
|Hospital del Carme|
|Badalona, Barcelona, Spain, 0|
|Primary Assistant Center Les Corts|
|Barcelona, Catalonia, Spain|
|Primary Assistant Center Sarrià|
|Barcelona, Catalonia, Spain|
|Principal Investigator:||Sandra Poudevida, PhD||Barcelonabeta Brain Research Center, Pasqual Maragall Foundation|