Psychological Support to Caregivers of Azlheimer's Patients Clinical Trial
— EMOCUIDAOfficial title:
Experimental Study of the Impact of a Structured Psychological Intervention Based on Group Therapy for Caregivers of Alzheimer's 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).
| Status | Completed |
| Enrollment | 83 |
| Est. completion date | July 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 95 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital del Carme | Badalona | Barcelona |
| Spain | Primary Assistant Center Les Corts | Barcelona | Catalonia |
| Spain | Primary Assistant Center Sarrià | Barcelona | Catalonia |
| Lead Sponsor | Collaborator |
|---|---|
| Barcelonabeta Brain Research Center, Pasqual Maragall Foundation |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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. | 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. | Pre-treatment and 4 weeks post treatment | No |
| Other | Change from baseline compared to the control and active arms using the Hospital Anxiety and Depression Scale (HADS) | 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. | Pre-treatment and 4 weeks post treatment | No |
| Primary | 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. | Pre-treatment and 4 weeks post treatment | No |
| Secondary | 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'). | Pre-treatment and 4 weeks post treatment | No |