Psychological DisorderNCT06048783
Feasibility and Preliminary Effects of a Spiritual Care Strategy on Psychological Disorders in Critically Ill Patients
A study testing Program of systematic and periodic spiritual accompaniment and care in people with Psychological Disorder and Critical Illness, run by Pontificia Universidad Catolica de Chile.
Trial summary
Studies in hospitalized patients have shown that a large percentage of them consider religion or spirituality to be an important factor in enabling them to cope with a serious illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Disorder, Critical Illness
- What is being tested?
- Program of systematic and periodic spiritual accompaniment and care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient who has had at least 72 hours of Invasive Mechanical Ventilation
- Patient currently in ICU
- Glasgow 15 at the moment of the screening
Who cannot join
- Patient who required mechanical ventilation in another episode of hospitalization in the 2 months before screening.
- Patients with primary neurological or neurosurgical disease.
- Presence of mental or intellectual disability prior to hospitalization or communication/language barriers.
- Pre-existing comorbidity with a life expectancy not exceeding 6 months (eg, metastatic cancer).
- Readmission to the ICU (patients can only be included if they are on their first ICU admission of the present hospitalization).
- No fixed address for follow-up.
- Patients with moderate to severe visual or hearing impairment.
- Early limitation of therapeutic effort.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Paula Repetto, PhD contact
About this study
Studies in hospitalized patients have shown that a large percentage of them consider religion or spirituality to be an important factor in enabling them to cope with a serious illness. Studies conducted in the ICU, have shown that spiritual care from a chaplain/priest is associated with increased satisfaction in family members of critically ill patients, however, the focus has traditionally been on offering support to family members and not to patients. Interventions for critically ill patients have mostly been implemented by chaplains or a member of the health care team, primarily nurses. Although these studies show promising results in terms of quality of life, they mostly reflect the perspective of the health teams and not that of the patients, they are not evaluated with standardized instruments and, in general, they are not standardized strategies.
Given that this will be one of the first studies with patients who received care in the ICU, it is proposed to conduct a pilot and feasibility study to gather lessons to implement a larger study. Studies of this type place greater emphasis on evaluating the feasibility of implementing the intervention and therefore this study will seek to: (1) evaluate the feasibility of implementing the intervention in a hospital setting, including participant recruitment procedures; (2) evaluate how the intervention, format and manner of implementation is received by participants; (3) preliminarily evaluate the impact on psychological symptomatology associated with PICS at the end of the intervention, at 3 and 6 months post-intervention.
Showing the impact of spiritual care on health outcomes of individuals, through studies such as this one, may contribute to a paradigm shift from a biomedical perspective to a holistic view of ICU patients. Although the technological and advanced life support offered by the ICU is essential for critical patients, but survival of a severe disease without a good quality of life makes it necessary to seek strategies to improve this problem, which undoubtedly requires a comprehensive approach to the person, through medical-physiological care and spiritual care.
Read the detailed description
Many patients who survive a critical illness suffer physical, psychological and cognitive problems, negatively impacting their quality of life, which has been termed Post-ICU Syndrome (PICS). Some studies have reported a residual effect several months after discharge from the ICU, affecting people's quality of life and functionality. Among the psychological symptoms of PICS are described symptoms of depression, anxiety and post-traumatic stress disorder (PTSD). It is estimated that at least 50% of ICU survivors will present psychological symptoms of PICS at discharge and other studies report that a quarter of survivors present PTSD symptoms one year after discharge from the ICU.
Spirituality should be an essential element of health care, as it is part of the essence of being human. International accreditation associations and scientific societies suggest incorporating spiritual care into the usual standards of care. Studies of hospitalized patients have shown that a large percentage of patients consider religion or spirituality to be an important factor in enabling them to cope with serious illness. And although previous studies have shown that chaplain/priest care is associated with increased satisfaction in family members of critically ill patients, the focus has traditionally been on offering support to family members and not to patients. However, there is a growing recognition of the need for a comprehensive approach in health care to provide spiritual support to ICU patients that is evaluated and contributes to improving the quality of life of these individuals. On the other hand, showing the impact of spiritual care on health outcomes of individuals, through studies such as this one, can contribute to a paradigm shift from a biomedical perspective to a holistic view of ICU patients. The technological and advanced life support offered by the ICU is essential for critically ill patients, but the survival of a severe disease without a good quality of life makes it necessary to seek strategies to improve this problem, which undoubtedly requires a comprehensive approach to the person, through medical-physiological care and spiritual care.
The proposed design aims to evaluate the feasibility of implementing a spiritual accompaniment intervention for patients who received care in the ICU, and to begin to implement it during hospitalization. This will provide information regarding the feasibility of implementing an intervention of this type in this context, offering it during hospitalization and its remote implementation process, once the patient is discharged. Considering that these studies work with small samples, it is not necessary to estimate the sample calculation. However, in order to obtain some preliminary results of the effect of the intervention, a sample of 15 people per group will be recruited and followed up until 6 months after discharge, which will allow us to evaluate changes over time in PICS symptoms. It is proposed that the intervention will begin during hospitalization, so that it will have a preventive nature and help mitigate the impact of ICU hospitalization on the development of mental health symptoms in patients. Participants will be randomly assigned to groups and will be evaluated considering intention to treat. On the other hand, gathering the perspective of volunteers, patients and research support team will provide us with inputs to improve the intervention and the best way to implement it.
- Conditions
- Psychological Disorder, Critical Illness
- Being tested
- Program of systematic and periodic spiritual accompaniment and care
- Keywords
- Post traumatic stress disorder, Intensive Care, Critically ill patients, Spiritual Care
- Medical subject headings
- Mental Disorders, Critical Illness, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program of systematic and periodic spiritual accompaniment and careBehavioural
Systematic and periodic spiritual accompaniment and care
| Study group | Role | What they receive |
|---|---|---|
| Program of systematic and periodic spiritual accompaniment and care | Experimental | A minimum of 3 sessions of spiritual accompaniment by trained volunteers, considering a 1:1 ratio (patient:companion). The topics that will be proposed during the sessions are: sense of suffering, uncertainty, death, life after life, ideas about healing, forgiveness and guilt, etc. In addition, the spiritual needs of the participants will be explored through an instrument specially designed for this purpose and culturally adapted in Chile (FICA). The spiritual accompaniment sessions will be implemented preferably at a distance, using zoom or video call. Receives: Behavioral: Program of systematic and periodic spiritual accompaniment and care |
| Standard Care | No intervention | It correspond to spiritual care currently offered by the hospital. This consists of the possibility of being assisted by a Catholic priest or being contacted by pastors from Protestant churches. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of enrollment
Proportion of eligible patients that are consented and enrolled in the trial
Measured: From recruitment to enrollment (i.e. up to 120 days)
Attendance Rate
Proportion of participants who attend all three intervention sessions
Measured: 2 weeks
Follow-up rate
Proportion of patients who attend all follow-up assessment
Measured: 3 and 6 months post ICU discharge
Intervention Satisfaction Survey
Satisfaction of the intervened group with the spiritual care will be assessed by a satisfaction survey.
Measured: 1-2 weeks and 3 months after the last session
Secondary outcomes (4)
Intervention Satisfaction Survey
Volunteer satisfaction with the spiritual care and accompaniment intervention will be assessed by a satisfaction survey.
Measured: 1-2 weeks after the last session
Post traumatic syndrome assessed by the Revised impact event scale (IES-R)
The post traumatic syndrome will be evaluated thanks to the chilean version of the Revised impact event scale (IES-R) giving a score going from 0 to 88. This scale has a score from 0 to 88, defining a post-traumatic stress disorder with a score higher than 43.
Measured: 3 and 6 months post ICU discharge
Anxiety and depression symptoms assessed by Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item(1 - 4 points) measure designed to assess anxiety and depression symptoms in medical patients. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores higher than 11 on either scale indicate a definitive case.
Measured: 3 and 6 months post ICU discharge
Perceptions of patients, volunteers and research team about the intervention, its components, training and recommendations, and difficulties encountered
At the end of the study, three focus group will be held with the participants, volunteers and the research team. In the focus group, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Thematic analysis method will be used in the evaluation of the data.
Measured: 2-3 weeks after the last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
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 Psychological DisorderStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Repetto, PhD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048783
- Sponsor's protocol ID
- 220111005
- Status last verified
- Dec 2024
- First submitted
- 24 Aug 2023
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Repetto P, Ruiz C, Rojas V, Olivares P, Bakker J, Alegria L. Spiritual care for prevention of psychological disorders in critically ill patients: study protocol of a feasibility randomised controlled pilot trial. BMJ Open. 2025 Apr 3;15(4):e084914. doi: 10.1136/bmjopen-2024-084914.
PubMed 40180407
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effects of a Spiritual Care Strategy on Psychological Disorders in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06048783
- Acronym / sponsor ID
- 220111005
- Conditions
- Psychological Disorder, Critical Illness
- Keywords
- Post traumatic stress disorder, Intensive Care, Critically ill patients, Spiritual Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 21 Sep 2023 (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.
Studies in hospitalized patients have shown that a large percentage of them consider religion or spirituality to be an important factor in enabling them to cope with a serious illness. Studies conducted in the ICU, have shown that spiritual care from a chaplain/priest is associated with increased satisfaction in family members of critically ill patients, however, the focus has traditionally been on offering support to family members and not to patients. Interventions for critically ill patients have mostly been implemented by chaplains or a member of the health care team, primarily nurses. Although these studies show promising results in terms of quality of life, they mostly reflect the perspective of the health teams and not that of the patients, they are not evaluated with standardized instruments and, in general, they are not standardized strategies.
Given that this will be one of the first studies with patients who received care in the ICU, it is proposed to conduct a pilot and feasibility study to gather lessons to implement a larger study. Studies of this type place greater emphasis on evaluating the feasibility of implementing the intervention and therefore this study will seek to: (1) evaluate the feasibility of implementing the intervention in a hospital setting, including participant recruitment procedures; (2) evaluate how the intervention, format and manner of implementation is received by participants; (3) preliminarily evaluate the impact on psychological symptomatology associated with PICS at the end of the intervention, at 3 and 6 months post-intervention.
Showing the impact of spiritual care on health outcomes of individuals, through studies such as this one, may contribute to a paradigm shift from a biomedical perspective to a holistic view of ICU patients. Although the technological and advanced life support offered by the ICU is essential for critical patients, but survival of a severe disease without a good quality of life makes it necessary to seek strategies to improve this problem, which undoubtedly requires a comprehensive approach to the person, through medical-physiological care and spiritual care.
Detailed description
Many patients who survive a critical illness suffer physical, psychological and cognitive problems, negatively impacting their quality of life, which has been termed Post-ICU Syndrome (PICS). Some studies have reported a residual effect several months after discharge from the ICU, affecting people's quality of life and functionality. Among the psychological symptoms of PICS are described symptoms of depression, anxiety and post-traumatic stress disorder (PTSD). It is estimated that at least 50% of ICU survivors will present psychological symptoms of PICS at discharge and other studies report that a quarter of survivors present PTSD symptoms one year after discharge from the ICU.
Spirituality should be an essential element of health care, as it is part of the essence of being human. International accreditation associations and scientific societies suggest incorporating spiritual care into the usual standards of care. Studies of hospitalized patients have shown that a large percentage of patients consider religion or spirituality to be an important factor in enabling them to cope with serious illness. And although previous studies have shown that chaplain/priest care is associated with increased satisfaction in family members of critically ill patients, the focus has traditionally been on offering support to family members and not to patients. However, there is a growing recognition of the need for a comprehensive approach in health care to provide spiritual support to ICU patients that is evaluated and contributes to improving the quality of life of these individuals. On the other hand, showing the impact of spiritual care on health outcomes of individuals, through studies such as this one, can contribute to a paradigm shift from a biomedical perspective to a holistic view of ICU patients. The technological and advanced life support offered by the ICU is essential for critically ill patients, but the survival of a severe disease without a good quality of life makes it necessary to seek strategies to improve this problem, which undoubtedly requires a comprehensive approach to the person, through medical-physiological care and spiritual care.
The proposed design aims to evaluate the feasibility of implementing a spiritual accompaniment intervention for patients who received care in the ICU, and to begin to implement it during hospitalization. This will provide information regarding the feasibility of implementing an intervention of this type in this context, offering it during hospitalization and its remote implementation process, once the patient is discharged. Considering that these studies work with small samples, it is not necessary to estimate the sample calculation. However, in order to obtain some preliminary results of the effect of the intervention, a sample of 15 people per group will be recruited and followed up until 6 months after discharge, which will allow us to evaluate changes over time in PICS symptoms. It is proposed that the intervention will begin during hospitalization, so that it will have a preventive nature and help mitigate the impact of ICU hospitalization on the development of mental health symptoms in patients. Participants will be randomly assigned to groups and will be evaluated considering intention to treat. On the other hand, gathering the perspective of volunteers, patients and research support team will provide us with inputs to improve the intervention and the best way to implement it.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program of systematic and periodic spiritual accompaniment and care | Experimental | Behavioral: Program of systematic and periodic spiritual accompaniment and careA minimum of 3 sessions of spiritual accompaniment by trained volunteers, considering a 1:1 ratio (patient:companion). The topics that will be proposed during the sessions are: sense of suffering, uncertainty, death, life after life, ideas about healing, forgiveness and guilt, etc. In addition, the spiritual needs of the participants will be explored through an instrument specially designed for this purpose and culturally adapted in Chile (FICA). The spiritual accompaniment sessions will be implemented preferably at a distance, using zoom or video call. |
| Standard Care | No intervention | –It correspond to spiritual care currently offered by the hospital. This consists of the possibility of being assisted by a Catholic priest or being contacted by pastors from Protestant churches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient who has had at least 72 hours of Invasive Mechanical Ventilation
- Patient currently in ICU
- Glasgow 15 at the moment of the screening
Key exclusion criteria (8 listed)
- Patient who required mechanical ventilation in another episode of hospitalization in the 2 months before screening.
- Patients with primary neurological or neurosurgical disease.
- Presence of mental or intellectual disability prior to hospitalization or communication/language barriers.
- Pre-existing comorbidity with a life expectancy not exceeding 6 months (eg, metastatic cancer).
- Readmission to the ICU (patients can only be included if they are on their first ICU admission of the present hospitalization).
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 |
|---|---|---|
| Program of systematic and periodic spiritual accompaniment and careSystematic and periodic spiritual accompaniment and care | Behavioural | Program of systematic and periodic spiritual accompaniment and care |
Primary outcome
Rate of enrollment
Time frame: From recruitment to enrollment (i.e. up to 120 days)
Proportion of eligible patients that are consented and enrolled in the trial
Attendance Rate
Time frame: 2 weeks
Proportion of participants who attend all three intervention sessions
Follow-up rate
Time frame: 3 and 6 months post ICU discharge
Proportion of patients who attend all follow-up assessment
Intervention Satisfaction Survey
Time frame: 1-2 weeks and 3 months after the last session
Satisfaction of the intervened group with the spiritual care will be assessed by a satisfaction survey.
4 secondary outcomes
Intervention Satisfaction Survey
Time frame: 1-2 weeks after the last session
Post traumatic syndrome assessed by the Revised impact event scale (IES-R)
Time frame: 3 and 6 months post ICU discharge
Anxiety and depression symptoms assessed by Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 and 6 months post ICU discharge
Perceptions of patients, volunteers and research team about the intervention, its components, training and recommendations, and difficulties encountered
Time frame: 2-3 weeks after the last session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Derived from this study: PubMed 40180407Repetto P, Ruiz C, Rojas V, Olivares P, Bakker J, Alegria L. Spiritual care for prevention of psychological disorders in critically ill patients: study protocol of a feasibility randomised controlled pilot trial. BMJ Open. 2025 Apr 3;15(4):e084914. doi: 10.1136/bmjopen-2024-084914.
- 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.
Paula Repetto, PhD contact
Paula Repetto, PhD principal investigator
Pontificia Universidad Catolica de Chile
Questions about this trial
What is this clinical trial studying?
A study testing Program of systematic and periodic spiritual accompaniment and care in people with Psychological Disorder and Critical Illness, run by Pontificia Universidad Catolica de Chile.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leyla Alegria, MSc (+56223549024, lmalegri@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of enrollment (time frame: From recruitment to enrollment (i.e. up to 120 days)). The study lists 4 primary outcomes in all. 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 NCT06048783, 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 30 Dec 2024.