A Psychological Intervention for Family Caregivers of Palliative Care Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Palliative Care

Intervention / Treatment
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* Other: Psychological intervention for family caregivers of patients at the end of life


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Group pf participants that received usual psychological attention. | |
| Experimental: Experimental group<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention study, Family caregiver, Overburden, Anxiety, Depression