A Psychological Intervention for Family Caregivers of Palliative Care Patients

NCT04076670 | Completed

• 1 other identifier: PSI2010-19426
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palliative Care

Keywords

Intervention study; Family caregiver; Overburden; Anxiety; Depression

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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.

Other: Psychological intervention for family caregivers of patients at the end of life

Interventions

Psychological intervention for family caregivers of patients at the end of life OTHER

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).

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• To present cognitive impairment.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Universitat de València

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Pilar Barreto Martin, PhD

  Universitat de València

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesora Titular

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 3, 2019
• Study Start: May 31, 2016
• Primary Completion: May 31, 2019
• Study Completion: July 31, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)