Group Therapy for Caregivers of Alzheimer's Disease Patients in Spanish Elderly Persons Centres

Study Overview
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Brief Summary
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An experimental study 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 16 sessions of a cognitive-behavioral psychological group therapy. This study aims to demonstrate that Alzheimer's patients' caregivers can decrease the feelings of burden after been involved in a group therapy.

Official Title
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Group Therapy for Caregivers of Alzheimer's Disease Patients in Spanish Elderly Persons Centres

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Behavioral: Psychotherapy groups
* Behavioral: Self-help groups


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Main caregiver of an Alzheimer Disease Patient. Alzheimer Disease Patient with mild/severe cognitive impairment. High compliance to therapy sessions. Sign informed consent. Exclusion Criteria: Low commitment to develop all study phases. Caregiver activity remunerated. Caregiver with psychiatric disorders that can affect the development of the sessions. Caregivers who have received psychological care during last year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy group with follow up sessions<br>Weekly psychotherapy groups during 4 months with a monthly follow up period (12 months) | Behavioral: Psychotherapy groups<br> <br> |
| Experimental: Therapy group without follow up sessions<br>Weekly psychotherapy groups during 4 months | Behavioral: Psychotherapy groups<br> <br> |
| Active Comparator: Active comparator group<br>Weekly self-help groups during 4 months with a monthly follow up period (12 months) | Behavioral: Self-help groups<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview. |  | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in caregiver burden from baseline compared to the control and active arms measured by Zarit Burden Interview. |  | 4 months and 16 months | 
| Change in anxiety and depression from baseline compared to the control and active arms measured by Goldberg Scale. |  | 4 months and 16 months | 
| Descriptive analysis of the caregivers' characteristics (sociodemographics, relation wih the AD patient). |  | Baseline (0 months) | 
| Descriptive analysis of the caregiver's cognition using DEM-DETECT Module 1. |  | 4 months | 
| Preliminary cost-effectiveness analysis related resources needed to caregivers and Alzheimer patients. |  | 4 months - 16 months | 
| Change in quality of life from baseline compared to the control and active arms measured by Casp-19 and SF-36 questionnaires. |  | 4 months - 16 months | 
| Change in resilience from baseline compared to the control and active arms measured by Connor-Davidson Resilience Scale. |  | 4 months - 16 months | 
| Change in functional social support from baseline compared to the control and active arms using Duke-UNC questionnaire. |  | 4 months - 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family Caregivers, Psychotherapy Group