Palliative CareNCT04076670
A Psychological Intervention for Family Caregivers of Palliative Care Patients
A study testing Psychological intervention for family caregivers of patients at the end of life in people with Palliative Care, run by University of Valencia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care
- What is being tested?
- Psychological intervention for family caregivers of patients at the end of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSpain
- Study dates
- 31 May 2016to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- To present cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of a Psychological Intervention in 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.
- Conditions
- Palliative Care
- Being tested
- Psychological intervention for family caregivers of patients at the end of life
- Keywords
- Intervention study, Family caregiver, Overburden, Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological intervention for family caregivers of patients at the end of lifeOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Psychological intervention for family caregivers of patients at the end of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start31 May 2016
- Primary completion31 May 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Antonia Pérez-Marín, University of Valencia
- Investigators
- Pilar Barreto Martin, PhD, Principal investigator, Universitat de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076670
- Sponsor's protocol ID
- PSI2010-19426
- Status last verified
- Aug 2019
- First submitted
- 28 Aug 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a Psychological Intervention in Family Caregivers of Palliative Care Patients
- ClinicalTrials.gov ID
- NCT04076670
- Acronym / sponsor ID
- PSI2010-19426
- Conditions
- Palliative Care
- Keywords
- Intervention study, Family caregiver, Overburden, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Group pf participants that received usual psychological attention. |
| Experimental group | Experimental | Other: Psychological intervention for family caregivers of patients at the end of lifeGroup of participants that received usual psychological attention plus the structured psychological intervention prosed in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- To present cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological intervention for family caregivers of patients at the end of lifeThe 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). | Other | Experimental group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Palliative Care
Not yet recruitingObservational study
IN-TALK: Co-producing a Hospice Intimacy Support Toolkit in England
Communication About Intimacy Needs in Hospice and Palliative Care
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
Not yet recruiting
Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors
Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Barreto Martin, PhD principal investigator
Universitat de València
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological intervention for family caregivers of patients at the end of life in people with Palliative Care, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety (PRE and POST measures) (time frame: Baseline up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.