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NCT Number: NCT01762618

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

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Key information

Conditions

Psychological Support to Caregivers of Azlheimer's Patients Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Carme, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy Group

Behavioral

Therapy Groups

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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').

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Other

Registry information

Official study title

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

Acronym: EMOCUIDA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 8, 2013
Registry last updated
Jul 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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