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NCT Number: NCT04076670

A Psychological Intervention for Family Caregivers of Palliative Care Patients

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.

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Key information

Conditions

Palliative Care Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat de València

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Change in anxiety (PRE and POST measures)

    Time frame: 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.

  2. Change in depression (PRE and POST measures)

    Time frame: 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.

  3. Change in burden (PRE and POST measures)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 3, 2019
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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