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CompletedNCT03995095Updated Jun 27, 2019

Intervention in Spirituality at the End of Life. The Kibo Protocol

An interventional study of Therapeutic interview: kibo protocol in Palliative Care, sponsored by University of Valencia. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-27.

Sponsored by University of Valencia · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Mar 2016, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Palliative Care

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Keywords

  • Spirituality
  • Intervention Study
03

In context

Death

572 studies on the registry are indexed under Death; 111 are open to participants now.

This study's enrollment of 60 is below the median of 133 across 260 interventional studies indexed under Death.

Browse Death studies →

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. To be 18 or more years of age.
  2. Being in advanced or terminal disease phase (following World Health Organization criteria).
  3. To have preserved cognitive capacity.
  4. To have signed the informed consent.

Exclusion criteria

Exclusion Criteria:

a) Estimated time of survival: Patients with a life expectancy of two weeks or less will not be intervened.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    Control group

    Group of participants that received usual psychological attention.

  • Experimental
    Experimental group

    Group of participants that received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).

    Other: Therapeutic interview: kibo protocol

Interventions

  • OtherTherapeutic interview: kibo protocol

    The kibo protocol is a therapeutic interview designed to address the spiritual needs of patients at the end of life.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline up to 4 weeks

Secondary outcomes

  1. 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).

    Time frame: Baseline up to 4 weeks

  2. 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).

    Time frame: Baseline up to 4 weeks

07

Study locations

1 site
  • Universitat de València
    Valencia, 46010, Spain
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03995095
Lead sponsor
University of Valencia
Collaborators
Sociedad Española de Cuidados Paliativos SECPAL
Responsible party
M. Antonia Pérez-Marín (Profesora Titular, University of Valencia) — Principal investigator
First posted
Jun 21, 2019
Start date
Mar 1, 2016
Primary completion
Dec 31, 2018
Completion
Mar 31, 2019
Last update
Jun 27, 2019

Study contacts

Pilar Barreto Martin, PhD
principal investigator · Universitat de València

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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