Experimental Study of the Impact of a Structured Psychological Intervention Based on Group Therapy for Caregivers of Alzheimer's Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 4
- 主要终点
- Change from baseline in POMS Scale ("Profile of Mood States")
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline in POMS Scale ("Profile of Mood States")
时间窗: 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.
次要结局
- 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.(Pre-treatment and 4 weeks post treatment)