AnxietyCFP-RCTNCT03702634
Chaplain Family Project Trial
A study testing Spiritual Care Assessment and Intervention (SCAI) framework in people with Anxiety and PTSD, run by Indiana University at 2 sites in United States.
Trial summary
Our research team has designed a chaplain delivered intervention focused on surrogate decision makers for hospitalized adults in the ICU. In this study, surrogates will complete an enrollment interview with research staff, including the completion of anxiety screening (GAD-7). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, PTSD, Depression
- What is being tested?
- Spiritual Care Assessment and Intervention (SCAI) framework
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2018to 4 Nov 2021
- 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
- Cognitive Requirements
- Patient is not decisional due to:
- Intubation (other than surgery- see exclusion criteria below)
- Sedation
- Unresponsive
- otherwise unable to communicate (AMS, dementia, delirium, etc.)
- Decision Support Requirements
- Patient has a qualified surrogate decision maker
Who cannot join
- Intubated for surgery and expected to be extubated within 24 hours
- Imminently dying as evidenced by patient notes
- Patient and/or family have a care contract or other restriction due to complicated or volatile situation
- Patient is a prisoner
- Patient is being followed by Adult Protective Services (APS)
- Patient meets cognitive criteria but does not have a qualified surrogate decision maker
Trial locations and contacts
2 sites in 1 country.
United States2 sites
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
IU Health University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Chaplain Family Project Randomized Controlled Trial
Our research team has designed a chaplain delivered intervention focused on surrogate decision makers for hospitalized adults in the ICU. In this study, surrogates will complete an enrollment interview with research staff, including the completion of anxiety screening (GAD-7). Based on their score the surrogate will be put into one of two groups, and then randomized to either the control or intervention group. Control group members will receive usual care, while intervention group members will meet with our study chaplain, who will provide the SCAI (Spiritual Care Assessment and Intervention) framework.
Read the detailed description
Unmet spiritual needs may have at least two negative consequences for surrogates. First, they may have high levels of spiritual distress, an important aspect of the surrogate's well-being. Second, surrogates include their religious and spiritual beliefs when making serious medical decisions . Therefore unmet spiritual needs may have a negative effect on the surrogate's ability to make good decisions for the patient, especially when facing extremely distressful decisions such as whether to continue life sustaining treatment or enroll in hospice.
The specific aims of this proposed study are:
- To determine the effect of the spiritual care intervention on psychological well-being for family surrogates at 3 months post discharge, including anxiety (primary outcome: GAD-7), depression (PHQ-9), Posttraumatic stress (IES-R), and overall distress.
- To determine the effect of the spiritual care intervention on spiritual well-being for family surrogates, (FACIT-SP- non-illness) and on religious coping (Brief RCOPE positive and negative).
- To determine the effects of the spiritual care intervention on other aspects of the surrogates' experience, including satisfaction with spiritual care (Patient Satisfaction Instrument--Chaplaincy) communication (FICS), overall satisfaction with the hospital stay (Picker single item) and decision conflict (DCS).
- To determine the effect of the intervention on treatment at the end of life (life sustaining treatments and hospice utilization) for patients who die in the hospital.
- To determine differences in outcomes between the intervention group, who will receive our intervention, and the control group, who will receive the usual care provided by the hospital chaplaincy service.
- Conditions
- Anxiety, PTSD, Depression, Communication, Satisfaction
- Being tested
- Spiritual Care Assessment and Intervention (SCAI) framework
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Depression, Communication, 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 study chaplain will work with the surrogate, using questions in four domains of spiritual care, to assess them and tailor the visit to their specific needs. The study chaplain will then utilize a pre-determined list of spiritual care interventions, and also document observable outcomes that occur at each visit (which are also listed within the SCAI framework).
| Study group | Role | What they receive |
|---|---|---|
| Control (Usual Care) | No intervention | Surrogate will receive usual care in the hospital, which could include visits from the unit chaplain or other staff from the spiritual care department. |
| Intervention | Experimental | Spiritual Care Assessment and Intervention (SCAI) framework Receives: Behavioral: Spiritual Care Assessment and Intervention (SCAI) framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge
GAD-7 (7 item inventory of anxiety)
Measured: Assessed at enrollment and again 6-8 weeks after hospital discharge
Secondary outcomes (3)
Change in depression from baseline enrollment interview to 6-8 weeks post patient discharge
PHQ-9 (9 item inventory of depression)
Measured: Assessed at enrollment and again 6-8 weeks after hospital discharge
Presence of post traumatic stress at 6-8 weeks post patient discharge
IES-R (Impact of Events scale- inventory for PTSD)
Measured: Assessed 6-8 weeks after hospital discharge
Change in overall distress from baseline enrollment interview to 6-8 weeks post patient discharge
Distress thermometer (a 1-10 scale developed by our team to assess distress)
Measured: Assessed at enrollment and again 6-8 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start28 Aug 2018
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
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 AnxietyStudies of the same condition, open and under way.
- 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
- Model description
- Arm 1- Control group Arm 2- Intervention group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Regenstrief Institute, Inc., Indiana University Health
- Responsible party
- Principal investigator, Alexia M. Torke, Indiana University
- Investigators
- Alexia M Torke, MD, MS, Principal investigator, Indiana University, IU Health, Regenstrief Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702634
- Sponsor's protocol ID
- 1806775750
- Acronym
- CFP-RCT
- Status last verified
- Mar 2022
- First submitted
- 4 Oct 2018
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torke AM, Varner-Perez SE, Burke ES, Taylor TA, Slaven JE, Kozinski KL, Maiko SM, Pfeffer BJ, Banks SK. Effects of Spiritual Care on Well-Being of Intensive Care Family Surrogates: A Clinical Trial. J Pain Symptom Manage. 2023 Apr;65(4):296-307. doi: 10.1016/j.jpainsymman.2022.12.007. Epub 2022 Dec 14.
PubMed 36526251
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chaplain Family Project Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03702634
- Acronym / sponsor ID
- CFP-RCT / 1806775750
- Conditions
- Anxiety, PTSD, Depression, Communication, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Regenstrief Institute, Inc., Indiana University Health
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 11 Oct 2018 (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.
Our research team has designed a chaplain delivered intervention focused on surrogate decision makers for hospitalized adults in the ICU. In this study, surrogates will complete an enrollment interview with research staff, including the completion of anxiety screening (GAD-7). Based on their score the surrogate will be put into one of two groups, and then randomized to either the control or intervention group. Control group members will receive usual care, while intervention group members will meet with our study chaplain, who will provide the SCAI (Spiritual Care Assessment and Intervention) framework.
Detailed description
Unmet spiritual needs may have at least two negative consequences for surrogates. First, they may have high levels of spiritual distress, an important aspect of the surrogate's well-being. Second, surrogates include their religious and spiritual beliefs when making serious medical decisions . Therefore unmet spiritual needs may have a negative effect on the surrogate's ability to make good decisions for the patient, especially when facing extremely distressful decisions such as whether to continue life sustaining treatment or enroll in hospice.
The specific aims of this proposed study are:
- To determine the effect of the spiritual care intervention on psychological well-being for family surrogates at 3 months post discharge, including anxiety (primary outcome: GAD-7), depression (PHQ-9), Posttraumatic stress (IES-R), and overall distress.
- To determine the effect of the spiritual care intervention on spiritual well-being for family surrogates, (FACIT-SP- non-illness) and on religious coping (Brief RCOPE positive and negative).
- To determine the effects of the spiritual care intervention on other aspects of the surrogates' experience, including satisfaction with spiritual care (Patient Satisfaction Instrument--Chaplaincy) communication (FICS), overall satisfaction with the hospital stay (Picker single item) and decision conflict (DCS).
- To determine the effect of the intervention on treatment at the end of life (life sustaining treatments and hospice utilization) for patients who die in the hospital.
- To determine differences in outcomes between the intervention group, who will receive our intervention, and the control group, who will receive the usual care provided by the hospital chaplaincy service.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1- Control group Arm 2- Intervention group
| Arm | Type | Receives |
|---|---|---|
| Control (Usual Care) | No intervention | –Surrogate will receive usual care in the hospital, which could include visits from the unit chaplain or other staff from the spiritual care department. |
| Intervention | Experimental | Behavioral: Spiritual Care Assessment and Intervention (SCAI) frameworkSpiritual Care Assessment and Intervention (SCAI) framework |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cognitive Requirements
- Patient is not decisional due to:
- Decision Support Requirements
- Patient has a qualified surrogate decision maker
Key exclusion criteria (6 listed)
- Intubated for surgery and expected to be extubated within 24 hours
- Imminently dying as evidenced by patient notes
- Patient and/or family have a care contract or other restriction due to complicated or volatile situation
- Patient is a prisoner
- Patient is being followed by Adult Protective Services (APS)
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 study chaplain will work with the surrogate, using questions in four domains of spiritual care, to assess them and tailor the visit to their specific needs. The study chaplain will then utilize a pre-determined list of spiritual care interventions, and also document observable outcomes that occur at each visit (which are also listed within the SCAI framework). | Behavioural | Intervention |
Primary outcome
Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge
Time frame: Assessed at enrollment and again 6-8 weeks after hospital discharge
GAD-7 (7 item inventory of anxiety)
3 secondary outcomes
Change in depression from baseline enrollment interview to 6-8 weeks post patient discharge
Time frame: Assessed at enrollment and again 6-8 weeks after hospital discharge
Presence of post traumatic stress at 6-8 weeks post patient discharge
Time frame: Assessed 6-8 weeks after hospital discharge
Change in overall distress from baseline enrollment interview to 6-8 weeks post patient discharge
Time frame: Assessed at enrollment and again 6-8 weeks after hospital discharge
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 28 Mar 2022.
- Derived from this study: PubMed 36526251Torke AM, Varner-Perez SE, Burke ES, Taylor TA, Slaven JE, Kozinski KL, Maiko SM, Pfeffer BJ, Banks SK. Effects of Spiritual Care on Well-Being of Intensive Care Family Surrogates: A Clinical Trial. J Pain Symptom Manage. 2023 Apr;65(4):296-307. doi: 10.1016/j.jpainsymman.2022.12.007. Epub 2022 Dec 14.
- 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.
Alexia M Torke, MD, MS principal investigator
Indiana University, IU Health, Regenstrief Institute
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 in people with Anxiety and PTSD, 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?
The sponsor lists 8 inclusion and 6 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 28 Mar 2022. 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?
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 from baseline enrollment interview to 6-8 weeks post patient discharge (time frame: Assessed at enrollment and again 6-8 weeks after hospital discharge). 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 NCT03702634, 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 28 Mar 2022.