A Psychological Intervention for Family Caregivers of Palliative Care Patients

Palliative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076670
• Other study ID #: PSI2010-19426
• Status: Completed
• Phase: N/A
• Start date: May 31, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2019
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: July 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• To present cognitive impairment.

Related Conditions & MeSH terms

• Palliative Care

Intervention

Other:
• Psychological intervention for family caregivers of patients at the end of life
The intervention protocol is a structured programme within the framework of counselling, that aims to reduce anxiety and depression symptoms, as well as symptoms of burden (overburden).

Locations

Country	Name	City	State
Spain	Universitat de València	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety (PRE and POST measures)	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.	Baseline up to 3 months
Primary	Change in depression (PRE and POST measures)	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.	Baseline up to 3 months
Primary	Change in burden (PRE and POST measures)	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.	Baseline up to 3 months