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临床试验/NCT04076670
NCT04076670已完成不适用

Benefits of a Psychological Intervention in Family Caregivers of Palliative Care Patients

University of Valencia2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2016年5月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
2
主要终点
Change in anxiety (PRE and POST measures)

研究概览

简要总结

This work aims to study the benefits a psychological intervention in family caregivers of palliative care patients can have for reducing anxiety, depression and overburden.

A parallel randomized controlled trial of two groups was performed. Information was collected on 154 family caregivers of patients at the end of life during the moments before and after the intervention.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be the main family caregiver of a patient at the end of life, receiven palliative care. In the present study, the main family caregiver is defined as follows: family member who assumes the main tasks of care and attends to the patient most of the time, or for a longer period of time than other members of the family.
  • To have signed the informed consent.

排除标准

  • To present cognitive impairment.

研究组 & 干预措施

Control group

No Intervention

Group pf participants that received usual psychological attention.

Experimental group

Experimental

Group of participants that received usual psychological attention plus the structured psychological intervention prosed in the study.

干预措施: Psychological intervention for family caregivers of patients at the end of life (Other)

结局指标

主要结局

Change in anxiety (PRE and POST measures)

时间窗: Baseline up to 3 months

This variable was assesed with the Hospital Anxiety and Depression Scale, HADS. This Scale contains 7 items asessing anxiety, where lower values represent a better outcome. In order to observe the change in anxiety, it was measured at two time points: First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: POST. Up to 3 months after the first measurement the second measurement of the same variable was carried out. Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received the usual psychological attention plus the structured psychological intervention proposed in this study.

Change in depression (PRE and POST measures)

时间窗: Baseline up to 3 months

This variable was assesed with the Hospital Anxiety and Depression Scale, HADS. In order to observe the change in depression, it was measured at two time points: First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: POST. Up to 3 months after the first measurement the second measurement of the same variable was carried out. Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received the usual psychological attention plus the structured psychological intervention proposed in this study.

Change in burden (PRE and POST measures)

时间窗: Baseline up to 3 months

This variable was assesed with the Zarit Burden Inventory. In order to observe the change in burden, it was measured at two time points: First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: POST. Up to 3 months after the first measurement the second measurement of the same variable was carried out. Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received the usual psychological attention plus the structured psychological intervention proposed in this study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

M. Antonia Pérez-Marín

Profesora Titular

University of Valencia

研究点 (2)

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