Palliative CareNCT03995095
Intervention in Spirituality at the End of Life. The Kibo Protocol
A study testing Therapeutic interview: kibo protocol in people with Palliative Care, run by University of Valencia at 1 site in Spain.
Trial summary
This work aims to study the benefits that the therapeutic interview Kibo in palliative care patients can have for spirituality. A parallel randomized controlled trial of two groups was performed. Information was collected on 60 palliative care patients during the moments before and after the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Therapeutic interview: kibo protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2016to 31 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be 18 or more years of age.
- Being in advanced or terminal disease phase (following World Health Organization criteria).
- To have preserved cognitive capacity.
- To have signed the informed consent.
Who cannot join
- Estimated time of survival: Patients with a life expectancy of two weeks or less will not be intervened.
Trial locations and contacts
1 site in 1 country.
About this study
This work aims to study the benefits that the therapeutic interview Kibo in palliative care patients can have for spirituality.
A parallel randomized controlled trial of two groups was performed. Information was collected on 60 palliative care patients during the moments before and after the intervention.
- Conditions
- Palliative Care
- Being tested
- Therapeutic interview: kibo protocol
- Keywords
- Spirituality, Intervention Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic interview: kibo protocolOther
The kibo protocol is a therapeutic interview designed to address the spiritual needs of patients at the end of life.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Group of participants that received usual psychological attention. |
| Experimental group | Experimental | Group of participants that received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention). Receives: Other: Therapeutic interview: kibo protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the dimension of spirituality (PRE and POST measures)
This variable was assessed with the Spirituality questionnaire from the Spanish Society of Palliative Care (SECPAL). This questionnaire contains 8 items, and it provides scores from 0 to 32, where higher values represent a better outcome.
In order to observe the change in the dimension of spirituality, it was measured at in 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 4 weeks 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 usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).
Measured: Baseline up to 4 weeks
Secondary outcomes (2)
Change in resilience (PRE and POST measures)
This variable was assessed with the Brief Resilient Coping Scale (BRCS). This scale contains 4 items, and it provides scores from 4 to 20, where higher values represent a better outcome.
In order to observe the change in the dimension of resilience, it was measured at in 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 4 weeks 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 usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).
Measured: Baseline up to 4 weeks
Change in demoralization (PRE and POST measures)
This variable was assessed with the Short Demoralization Scale (SDS). This scale contains 5 items, and it provides scores from 0 to 20, where lower values represent a better outcome.
In order to observe the change in the dimension of demoralization, it was measured at in 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 4 weeks 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 usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).
Measured: Baseline up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Mar 2016
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Cuidados Paliativos SECPAL
- 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
- NCT03995095
- Sponsor's protocol ID
- H1447334931417
- Status last verified
- Jun 2019
- First submitted
- 5 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soto-Rubio A, Perez-Marin M, Rudilla D, Galiana L, Oliver A, Fombuena M, Barreto P. Responding to the Spiritual Needs of Palliative Care Patients: A Randomized Controlled Trial to Test the Effectiveness of the Kibo Therapeutic Interview. Front Psychol. 2020 Aug 21;11:1979. doi: 10.3389/fpsyg.2020.01979. eCollection 2020.
PubMed 32973614
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention in Spirituality at the End of Life. The Kibo Protocol
- ClinicalTrials.gov ID
- NCT03995095
- Acronym / sponsor ID
- H1447334931417
- Conditions
- Palliative Care
- Keywords
- Spirituality, Intervention Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Sociedad Española de Cuidados Paliativos SECPAL
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 21 Jun 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 that the therapeutic interview Kibo in palliative care patients can have for spirituality.
A parallel randomized controlled trial of two groups was performed. Information was collected on 60 palliative care patients 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 of participants that received usual psychological attention. |
| Experimental group | Experimental | Other: Therapeutic interview: kibo protocolGroup of participants that received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be 18 or more years of age.
- Being in advanced or terminal disease phase (following World Health Organization criteria).
- To have preserved cognitive capacity.
- To have signed the informed consent.
Key exclusion criteria (1 listed)
- Estimated time of survival: Patients with a life expectancy of two weeks or less will not be intervened.
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 |
|---|---|---|
| Therapeutic interview: kibo protocolThe kibo protocol is a therapeutic interview designed to address the spiritual needs of patients at the end of life. | Other | Experimental group |
Primary outcome
Change in the dimension of spirituality (PRE and POST measures)
Time frame: Baseline up to 4 weeks
This variable was assessed with the Spirituality questionnaire from the Spanish Society of Palliative Care (SECPAL). This questionnaire contains 8 items, and it provides scores from 0 to 32, where higher values represent a better outcome. In order to observe the change in the dimension of spirituality, it was measured at in 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 4 weeks 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 usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).
2 secondary outcomes
Change in resilience (PRE and POST measures)
Time frame: Baseline up to 4 weeks
Change in demoralization (PRE and POST measures)
Time frame: Baseline up to 4 weeks
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 27 Jun 2019.
- Derived from this study: PubMed 32973614Soto-Rubio A, Perez-Marin M, Rudilla D, Galiana L, Oliver A, Fombuena M, Barreto P. Responding to the Spiritual Needs of Palliative Care Patients: A Randomized Controlled Trial to Test the Effectiveness of the Kibo Therapeutic Interview. Front Psychol. 2020 Aug 21;11:1979. doi: 10.3389/fpsyg.2020.01979. eCollection 2020.
- Individual participant dataSharing planned: No
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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 Therapeutic interview: kibo protocol 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 4 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 27 Jun 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 the dimension of spirituality (PRE and POST measures) (time frame: Baseline up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03995095, which also lists 1 linked publication.
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 27 Jun 2019.