AnxietySF-ICUNCT07228299
Supporting Families in the ICU
A study testing Spiritual Care Assessment and Intervention (SCAI) Framework and ICU Guide in people with Anxiety and Well-Being, run by Indiana University at 2 sites in United States.
Trial summary
The overarching goal of our work is to test the effect of high-quality spiritual care for ICU family surrogates on outcomes of psychological and spiritual well-being and medical decision making. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Well-Being, Satisfaction
- What is being tested?
- Spiritual Care Assessment and Intervention (SCAI) Framework and ICU Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2027
- 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
We will enroll patient/surrogate dyads.
Patients will be eligible if:
- They are age 18 or older at the time of screening.
- They are judged to lack decisional capacity based on either: a Glasgow Coma Scale (GCS) score of 8 or less; or a GCS of 9-13 with at least one secondary criterion (intubation, sedation, delirium, or noted by clinicians to be unresponsive, comatose or unable to follow commands).
- They have an eligible surrogate willing to participate.
Surrogates will be eligible if:
- They are age 18 or older,
- They are considered the legally authorized representative (LAR) based on prior appointment by the patient or each state's medical consent law.
Patient/surrogate dyads will be ineligible if:
- They are unable to complete enrollment activities within 96 hours of admission to the ICU.
Patients will be ineligible if:
- They are being discharged from the ICU within 24 hours.
- They are intubated for surgery but expected to be extubated soon (typically within 24 hours).
- They are imminently dying or have a planned terminal wean.
Surrogates will be ineligible if:
*They are unable to complete study procedures in English.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexia M Torke, MD, MS contact
United States2 sites
University of California- San Francisco
San Francisco, California, 94143
Susan Conrad, MDiv, BCC, susan.conrad@ucsf.edu
Wake Forest University
Winston-Salem, North Carolina, 27157
Jennifer Gabbard, MD, jgabbard@wakehealth.edu
About this study
Official title: Supporting Families in the ICU: The Chaplain Family Project Multicenter RCT
The overarching goal of our work is to test the effect of high-quality spiritual care for ICU family surrogates on outcomes of psychological and spiritual well-being and medical decision making. Our team has developed an approach to high quality spiritual care intervention for ICU surrogates, called the Spiritual Care Assessment and Intervention (SCAI) framework, which is delivered by a chaplain interventionist to ICU surrogates.
Read the detailed description
To prepare for a fully powered, multi-center study, we propose a 2-arm, attention controlled, randomized pilot trial of high-quality spiritual care for 64 surrogates at 2 additional US medical centers.
Specific Aims are:
- To determine the feasibility and acceptability of all aspects of the study, including enrollment, randomization, delivery of the SCAI framework (e.g., chaplain intervention) and attention control conditions, acceptability, and outcome assessments, in preparation for a larger, Stage III effectiveness trial.
- To test the effects of spiritual care on the primary outcome of anxiety (GAD-7) and the secondary outcomes of surrogate spiritual well-being and satisfaction with spiritual care (FACIT-Sp-non-illness version, Satisfaction with Care-Chaplain), and decision making for the patient, including the process of decision making and the medical care received by the patient.
- To study the experience of spiritual care from the perspective of surrogates who are religious and those who are not, those of different faiths, and those who describe themselves as spiritual but not religious.
Because chaplains are common in the ICU this intervention is highly scalable. Results will guide hospital leaders, policy makers and the healthcare team regarding how to deploy chaplains to improve surrogates' psychological and spiritual health and the quality of decisions for critically ill patients.
- Conditions
- Anxiety, Well-Being, Satisfaction
- Being tested
- Spiritual Care Assessment and Intervention (SCAI) Framework, ICU Guide
- Keywords
- spirituality, religion, surrogate decision making, proxy decision making, chaplain
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiritual Care Assessment and Intervention (SCAI) FrameworkBehavioural
The SCAI intervention includes three visits generally scheduled 48-72 hours apart. After three visits, the chaplain will contact the surrogate at least weekly for the remainder of the hospitalization. If the patient dies, the chaplain will conduct a bereavement visit.
The SCAI framework addresses four dimensions of spirituality. If all four dimensions are not addressed, they may be assessed during follow-up visits. If all four dimensions are addressed during the initial visit, other visits include at least one question from any dimension.
The SCAI framework includes a list of common spiritual care interventions developed based on clinical experience and literature review.. Based on our conceptual framework, interventions are either are emotionally supportive, address spiritual or religious dimensions of care, or address information support such as exploring the meaning of medical events. Consistent with chaplain standards, the chaplain selects and tailors these interventions.
ICU GuideBehavioural
The ICU Guide intervention will include three visits with the site RA that are similar in duration to the chaplain visits (based on the single center study, first visit median of 23 minutes, follow-up visit median 12 minutes), with review of a brochure introducing the family member to the ICU including staff, policies and procedures that will be helpful to the family member.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (SCAI Framework) | Experimental | Participants in this arm will receive the chaplain led intervention of the Spiritual Care Assessment and Intervention (SCAI) framework. Receives: Behavioral: Spiritual Care Assessment and Intervention (SCAI) Framework |
| Control (ICU Guide) | Active comparator | Participants in this arm will participate in meetings with a member of the research team to review an ICU guide. Receives: Behavioral: ICU Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the intervention on surrogate anxiety (GAD-7)
Generalized Anxiety Disorder- 7 (GAD-7) (7 item inventory of anxiety)- assesses subject's self-reported anxiety for the last two weeks. Scores range from 0-21 0= 'Not at all'; 1= 'Several Days'; 2= 'More than half the days'; 3= 'Nearly every day' Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD.
Measured: Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital
Secondary outcomes (3)
Effect of the intervention on surrogate spiritual well-being (FACIT-Sp)
Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT- Sp) Scale, a 12-item questionnaire used to measure spiritual well-being in people with chronic illnesses. It assesses aspects like meaning, peace, and faith, and is widely used in research and clinical settings, particularly for patients with cancer and other serious health conditions.
Measured: Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital
Decision making quality (FS-ICU)
Family Satisfaction with the ICU Process of Decision Making Subscale, a 4 item inventory of decision making quality
Measured: Assessed 6-8 weeks after the patient has discharged from the hospital
Satisfaction with Spiritual Care (PSI-C)
Patient Satisfaction Instrument- Chaplaincy includes 23 clinical statements which are rated on a 4 (strongly agree) to 1 (strongly disagree) scale.
Measured: Assessed 6-8 weeks after the patient has discharged from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Regenstrief Institute, Inc., University of California, San Francisco, Wake Forest University, Rush University, Oregon Health and Science University
- Responsible party
- Principal investigator, Alexia M. Torke, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228299
- Sponsor's protocol ID
- 27922
- Other IDs
- R56AG086388
- Acronym
- SF-ICU
- Status last verified
- Jul 2026
- First submitted
- 8 Oct 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Families in the ICU: The Chaplain Family Project Multicenter RCT
- ClinicalTrials.gov ID
- NCT07228299
- Acronym / sponsor ID
- SF-ICU / 27922
- Conditions
- Anxiety, Well-Being, Satisfaction
- Keywords
- spirituality, religion, surrogate decision making, proxy decision making, chaplain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Regenstrief Institute, Inc., University of California, San Francisco, Wake Forest University, Rush University, Oregon Health and Science University
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 14 Nov 2025 (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.
The overarching goal of our work is to test the effect of high-quality spiritual care for ICU family surrogates on outcomes of psychological and spiritual well-being and medical decision making. Our team has developed an approach to high quality spiritual care intervention for ICU surrogates, called the Spiritual Care Assessment and Intervention (SCAI) framework, which is delivered by a chaplain interventionist to ICU surrogates.
Detailed description
To prepare for a fully powered, multi-center study, we propose a 2-arm, attention controlled, randomized pilot trial of high-quality spiritual care for 64 surrogates at 2 additional US medical centers.
Specific Aims are:
- To determine the feasibility and acceptability of all aspects of the study, including enrollment, randomization, delivery of the SCAI framework (e.g., chaplain intervention) and attention control conditions, acceptability, and outcome assessments, in preparation for a larger, Stage III effectiveness trial.
- To test the effects of spiritual care on the primary outcome of anxiety (GAD-7) and the secondary outcomes of surrogate spiritual well-being and satisfaction with spiritual care (FACIT-Sp-non-illness version, Satisfaction with Care-Chaplain), and decision making for the patient, including the process of decision making and the medical care received by the patient.
- To study the experience of spiritual care from the perspective of surrogates who are religious and those who are not, those of different faiths, and those who describe themselves as spiritual but not religious.
Because chaplains are common in the ICU this intervention is highly scalable. Results will guide hospital leaders, policy makers and the healthcare team regarding how to deploy chaplains to improve surrogates' psychological and spiritual health and the quality of decisions for critically ill patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (SCAI Framework) | Experimental | Behavioral: Spiritual Care Assessment and Intervention (SCAI) FrameworkParticipants in this arm will receive the chaplain led intervention of the Spiritual Care Assessment and Intervention (SCAI) framework. |
| Control (ICU Guide) | Active comparator | Behavioral: ICU GuideParticipants in this arm will participate in meetings with a member of the research team to review an ICU guide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Spiritual Care Assessment and Intervention (SCAI) FrameworkThe SCAI intervention includes three visits generally scheduled 48-72 hours apart. After three visits, the chaplain will contact the surrogate at least weekly for the remainder of the hospitalization. If the patient dies, the chaplain will conduct a bereavement visit. The SCAI framework addresses four dimensions of spirituality. If all four dimensions are not addressed, they may be assessed during follow-up visits. If all four dimensions are addressed during the initial visit, other visits include at least one question from any dimension. The SCAI framework includes a list of common spiritual care interventions developed based on clinical experience and literature review.. Based on our conceptual framework, interventions are either are emotionally supportive, address spiritual or religious dimensions of care, or address information support such as exploring the meaning of medical events. Consistent with chaplain standards, the chaplain selects and tailors these interventions. | Behavioural | Intervention (SCAI Framework) |
| ICU GuideThe ICU Guide intervention will include three visits with the site RA that are similar in duration to the chaplain visits (based on the single center study, first visit median of 23 minutes, follow-up visit median 12 minutes), with review of a brochure introducing the family member to the ICU including staff, policies and procedures that will be helpful to the family member. | Behavioural | Control (ICU Guide) |
Primary outcome
Effect of the intervention on surrogate anxiety (GAD-7)
Time frame: Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital
Generalized Anxiety Disorder- 7 (GAD-7) (7 item inventory of anxiety)- assesses subject's self-reported anxiety for the last two weeks. Scores range from 0-21 0= 'Not at all'; 1= 'Several Days'; 2= 'More than half the days'; 3= 'Nearly every day' Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD.
3 secondary outcomes
Effect of the intervention on surrogate spiritual well-being (FACIT-Sp)
Time frame: Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital
Decision making quality (FS-ICU)
Time frame: Assessed 6-8 weeks after the patient has discharged from the hospital
Satisfaction with Spiritual Care (PSI-C)
Time frame: Assessed 6-8 weeks after the patient has discharged from the hospital
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 27 Aug 2026.
- 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.
Alexia M Torke, MD, MS contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiritual Care Assessment and Intervention (SCAI) Framework and ICU Guide in people with Anxiety and Well-Being, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
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 Emily S Burke, BA (317-274-9047, burkee@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the intervention on surrogate anxiety (GAD-7) (time frame: Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital). 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 27 Aug 2026.