Health BehaviorNCT03529812
CBCT for Spiritual Health Clinicians
A study testing CBCT-informed training in people with Health Behavior, run by Emory University at 7 sites in United States.
Trial summary
The Emory University Spiritual Health department will incorporate Cognitively-Based Compassion Training (CBCT) into their training curriculum beginning in Fall 2017, which provides the opportunity to compare students receiving the CBCT addendum with those receiving traditional chaplaincy training. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Behavior
- What is being tested?
- CBCT-informed training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Jul 2018to 7 May 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chaplain residents with Spiritual Health at Emory Healthcare
- Patient of Emory Healthcare
- Requested a spiritual health consultation with a hospital chaplain
Who cannot join
- None
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory Clinic
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Wesley Woods Center
Atlanta, Georgia, 30329
St. Joseph's Hospital
Atlanta, Georgia, 30342
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
About this study
Official title: Exploring the Effect of Cognitively-Based Compassion Training (CBCT) on the Empathic Accuracy and Resilience of Spiritual Health Clinicians
The Emory University Spiritual Health department will incorporate Cognitively-Based Compassion Training (CBCT) into their training curriculum beginning in Fall 2017, which provides the opportunity to compare students receiving the CBCT addendum with those receiving traditional chaplaincy training. This is a naturalistic study that examines the impact of incorporating CBCT into Emory's spiritual caregiver training program. The researchers will examine the effect of CBCT on empathic accuracy and resilience by comparing the first group of students who receive CBCT-informed training with chaplains who receive standard training in spiritual caregiving and receive CBCT later in the residency year. Comprehensive assessments will be conducted in order to examine whether outcomes for patients are improved for those receiving chaplain spiritual care augmented by CBCT compared to those receiving spiritual care from chaplains who receive CBCT later in their residency.
Read the detailed description
Based on a wealth of research demonstrating the associations between physical health and psychosocial well-being, modern health care in the United States is characterized by an increasingly patient-centered model of care that places a premium on the holistic treatment of the patient as a physical, psychosocial, and spiritual whole. Hospital chaplains play a vital role in delivering emotional and spiritual care to a broad range of both religious and non-religious patients for a wide variety of stressors, and extensive research indicates that spiritual consults impact patient outcomes and satisfaction. However, there is remarkably little research on the "active ingredients" of chaplaincy spiritual care, and a subsequent lack of standardization and best-practice guidelines informing chaplain training and chaplain spiritual consulting. CBCT ® (Cognitively-Based Compassion Training) is a secularized compassion meditation program adapted from the Tibetan Buddhist mind training (lojong) tradition, and it may be an ideal addendum to both chaplain training programs and to the spiritual care consults provided by Emory University hospital chaplains to approximately 100,000 patients each year. This is a pilot study to explore the feasibility and impact of incorporating CBCT into the educational curriculum for chaplain residents. To this end, the researchers will (1) examine the impact of CBCT on burnout, compassion, and empathic accuracy among chaplains in training, (2) explore whether the impact persists through the end of the resident training, (3) evaluate the timing of the training within the existing curriculum to maximize its impact, (4) evaluate whether CBCT-informed interventions improve patient outcomes, and (5) explore chaplain and patient mediators of the impact of spiritual care consults on patient outcomes. Data acquired in this pilot study will be used to estimate efficacy and to inform a randomized controlled trial.
- Conditions
- Health Behavior
- Being tested
- CBCT-informed training
- Keywords
- Behavioral intervention, Social intervention
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT-informed trainingBehavioural
Cognitively-Based Compassion Training (CBCT) is a secularized compassion meditation program adapted from the Tibetan Buddhist mind training (lojong) tradition. Lojong practices utilize a cognitive, analytic approach to challenge one's unexamined thoughts and emotions toward other people, with the long-term goal of developing altruistic emotions and behavior towards all people.
| Study group | Role | What they receive |
|---|---|---|
| Early-start group for CBCT-informed training | Experimental | Hospital chaplain residents receiving the Cognitively-Based Compassion Training (CBCT) education during the first unit of their year-long residency. Receives: Behavioral: CBCT-informed training |
| Delayed-start group for CBCT-informed training | Active comparator | Hospital chaplain residents receiving the Cognitively-Based Compassion Training (CBCT) education midway through their year-long residency. Receives: Behavioral: CBCT-informed training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Anxiety and Stress Scale (DASS) Score
The Depression Anxiety and Stress Scale (DASS) is a 42-item likert-scale measure that assesses the frequency of symptoms of depression, anxiety and stress during the past week. Respondents indicate the degree to which they agree with each statement on a scale of 0 to 3 where 0 = does not apply to me at all and 3 = applied to me very much, or most of the time. Total scores range from 0 to 126 and higher scores indicate increased feelings of depression, anxiety and stress.
Measured: Baseline, Week 5, Week 24, Week 29
Change in Mental Health Continuum Short Form (MHC-SF) Score
The Mental Health Continuum Short Form (MHC-SF) is a 14-item inventory assessing emotional well-being. Participants indicate how frequently they have experienced different feelings (such as feeling happy) in the past month. Responses are are a 6-point scale where 0 = never and 5 = every day. Total scores range from 0 to 70 and higher scores indicate greater well being.
Measured: Baseline, Week 5, Week 24, Week 29
Change in Professional Quality of Life Scale (ProQOL) Score
The Professional Quality of Life Scale (ProQOL) is a 30-item inventory, the ProQOL is the most commonly used measure of the negative and positive effects of helping others who experience suffering. It has sub-scales for compassion satisfaction, burnout, and compassion fatigue. The sub-scales are summed and converted to t-scores with a mean of 50 and standard deviation of 10. Scores higher than 57 indicate professional satisfaction while scores below 40 indicate possible problems with feeling satisfied professionally.
Measured: Baseline, Week 5, Week 24, Week 29
Change in School-Burnout Inventory (SBI) Score
The School-Burnout Inventory is a 9-item survey asking students about how much burnout, in the context of an academic environment, they have felt in the past month (for example, "I feel overwhelmed by my schoolwork"). Respondents indicate the degree to which they agree with each statement on a scale of 1 to 6 where 1 = completely disagree and 6 = completely agree. Total scores can range from 9 to 54, with higher scores indicating more burnout.
Measured: Baseline, Week 5, Week 24, Week 29
Change in Revised University of California, Los Angeles (UCLA) Loneliness Scale (R-UCLA) Score
The Revised UCLA Loneliness Scale (R-UCLA) is a 20-item questionnaire measuring general feelings of social isolation and dissatisfaction with one's social interactions. Participants rate each item on a scale from 1 (never) to 4 (often). When scoring the scale, certain items are reversed so that low scores correspond with low loneliness. Total scores range from 20 to 80, where high scores indicate high feelings of loneliness.
Measured: Baseline, Week 5, Week 24, Week 29
Change in Empathic Accuracy (EA) Task Score
The Empathic Accuracy (EA) Task is a dynamic video assessment that asks subjects to continuously rate the emotions of others as they tell emotional autobiographical stories. Empathic accuracy is the correlation between feelings of the story-tellers in the video and what the participants perceive the story-tellers feelings to be.
Measured: Baseline, Week 5, Week 24, Week 29
Change in Spiritual Meaning Scale (SMS) Score
The Spiritual Meaning Scale (SMS) is a 15-item, likert-scale inventory that assesses the extent to which someone endorses a belief in something larger than themselves. Participants respond to statements like "life is inherently meaningful" on a scale of 1 to 5 where 1 = I totally disagree, 3 = I'm in between, and 5 = I totally agree. Certain items are scored in reverse. The total score ranges from 15 to 75 and higher scores indicate stronger belief.
Measured: Baseline, Week 5, Week 24, Week 29
Change in Jefferson Scale of Empathy Score
The Jefferson Scale of Empathy is a 20-item scale designed to measure empathy in practicing health care professionals and health care professional students. Participants answer on a 7-point scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 20 to 140 where higher scores indicate increased empathy.
Measured: Baseline, Week 5, Week 24, Week 29
Secondary outcomes (8)
National Comprehensive Cancer Network (NCCN) Distress Thermometer
Patients will use the NCCN Distress Thermometer to rate levels of distress over the past week including the current day. The NCCN Distress Thermometer is a single-item screener of distress, with a scale from 0 (no distress) to 10 (extreme distress) represented through a visual graphic of a thermometer. Patients will complete the screening prior to having a Spiritual Health consult with the chaplain.
Measured: Day 1 (before Spiritual Health consult)
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Emotions
The PROMIS Self-Efficacy for Managing Emotions is a 15-item Likert scale self-report measure ("not at all confident"; "a little confident"; "somewhat confident"; "quite confident" and "very confident") completed by patients, which asks them to reflect on their own confidence levels in managing and controlling symptoms of anxiety, depression, helplessness, discouragement, frustration, disappointment, and anger. Raw scores range from 15 to 75 with higher scores indicating increased self efficacy. Patients will complete the questionnaire after having a Spiritual Health consult with the chaplain.
Measured: Day 1 (after Spiritual Health consult)
PROMIS Positive Affect
The PROMIS Positive Affect questionnaire is a 15-item Likert-scale self-report measure completed by patients, which assesses momentary positive or rewarding affective experiences such as feelings and moods associated with pleasure, joy, elation, contentment, pride, affection, happiness, engagement, and excitement. Raw scores range from 15 to 75 with higher scores indicating increased positive feelings. Patients will complete the questionnaire after having a Spiritual Health consult with the chaplain.
Measured: Day 1 (after Spiritual Health consult)
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire used to screen for the presence of depression and anxiety in physically ill patients. It is divided into two subscales: Anxiety (HADS-A) and Depression (HADS-D). Patients rate each item on a 4-point scale from 0 (absence) to 3 (extreme presence), with five of the 14 items reverse coded. Total scores range from 0 to 42, with higher scores indicating greater levels of anxiety and depression. Patients will complete the questionnaire after having a Spiritual Health consult with the chaplain.
Measured: Day 1 (after Spiritual Health consult)
PROMIS Emotional Support
The PROMIS Emotional Support is a 4-item Likert-scale that assesses perceived feelings of being cared for and valued as a person. Each of the 4 questions has five response options ranging in value from one to five, with total scores ranging from 4 to 20. Higher scores indicate increased feelings of being supported emotionally. Patients will complete the questionnaire after having a Spiritual Health consult with the chaplain.
Measured: Day 1 (after Spiritual Health consult)
PROMIS Informational Support
The PROMIS Informational Support is a 4-item Likert-scale that assesses perceived availability of helpful information or advice. Each of the 4 questions has five response options ranging in value from one to five, with total scores ranging from 4 to 20. Higher scores indicate increased perception of available information. Patients will complete the questionnaire after having a Spiritual Health consult with the chaplain.
Measured: Day 1 (after Spiritual Health consult)
PROMIS Social Isolation
The PROMIS Social Isolation is a 4-item Likert-scale that assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Each of the 4 questions has five response options ranging in value from one to five, with total scores ranging from 4 to 20. Higher scores indicate increased social isolation. Patients will complete the questionnaire after having a Spiritual Health consult with the chaplain.
Measured: Day 1 (after Spiritual Health consult)
Scottish Patient Reported Outcome Measure (PROM)
The Scottish Patient Reported Outcome Measure (PROM) is an 18-item self-report Likert-scale that assesses how a hospitalized patient perceived the Spiritual Care visit both during and after the consult. It also assesses the patient's present state regarding their situation and whether they view themselves as a spiritual or religious person. Responses range in value from 1 (not at all) to 5 (all of the time). Total scores range from 18 to 90 with higher scores suggesting increased positive feelings about the spiritual care received. Patients will complete the questionnaire after having a Spiritual Health consult with the chaplain.
Measured: Day 1 (after Spiritual Health consult)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start5 Jul 2018
- Primary completion7 May 2020
- Study completion7 May 2020
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 Health BehaviorStudies of the same condition, open and under way.
- More trials run by Emory 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study aims to enroll 30 hospital chaplain residents, 15 will have the CBCT intervention early and the other 15 will learn about CBCT later. Additionally, 500 patients who have spiritual services provided by the chaplains participating in the study will be enrolled in order to examine patient outcomes.
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Mascaro, Emory University
- Investigators
- Jennifer Mascaro, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529812
- Sponsor's protocol ID
- IRB00098222
- Status last verified
- May 2020
- First submitted
- 8 May 2018
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mascaro JS, Palmer PK, Ash MJ, Florian MP, Kaplan DM, Palitsky R, Cole SP, Shelton M, Raison CL, Grant GH. A randomized controlled trial of a compassion-centered spiritual health intervention to improve hospital inpatient outcomes. PLoS One. 2025 Mar 3;20(3):e0313602. doi: 10.1371/journal.pone.0313602. eCollection 2025.
PubMed 40029890
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Cognitively-Based Compassion Training (CBCT) on the Empathic Accuracy and Resilience of Spiritual Health Clinicians
- ClinicalTrials.gov ID
- NCT03529812
- Acronym / sponsor ID
- IRB00098222
- Conditions
- Health Behavior
- Keywords
- Behavioral intervention, Social intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 18 May 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.
The Emory University Spiritual Health department will incorporate Cognitively-Based Compassion Training (CBCT) into their training curriculum beginning in Fall 2017, which provides the opportunity to compare students receiving the CBCT addendum with those receiving traditional chaplaincy training. This is a naturalistic study that examines the impact of incorporating CBCT into Emory's spiritual caregiver training program. The researchers will examine the effect of CBCT on empathic accuracy and resilience by comparing the first group of students who receive CBCT-informed training with chaplains who receive standard training in spiritual caregiving and receive CBCT later in the residency year. Comprehensive assessments will be conducted in order to examine whether outcomes for patients are improved for those receiving chaplain spiritual care augmented by CBCT compared to those receiving spiritual care from chaplains who receive CBCT later in their residency.
Detailed description
Based on a wealth of research demonstrating the associations between physical health and psychosocial well-being, modern health care in the United States is characterized by an increasingly patient-centered model of care that places a premium on the holistic treatment of the patient as a physical, psychosocial, and spiritual whole. Hospital chaplains play a vital role in delivering emotional and spiritual care to a broad range of both religious and non-religious patients for a wide variety of stressors, and extensive research indicates that spiritual consults impact patient outcomes and satisfaction. However, there is remarkably little research on the "active ingredients" of chaplaincy spiritual care, and a subsequent lack of standardization and best-practice guidelines informing chaplain training and chaplain spiritual consulting. CBCT ® (Cognitively-Based Compassion Training) is a secularized compassion meditation program adapted from the Tibetan Buddhist mind training (lojong) tradition, and it may be an ideal addendum to both chaplain training programs and to the spiritual care consults provided by Emory University hospital chaplains to approximately 100,000 patients each year. This is a pilot study to explore the feasibility and impact of incorporating CBCT into the educational curriculum for chaplain residents. To this end, the researchers will (1) examine the impact of CBCT on burnout, compassion, and empathic accuracy among chaplains in training, (2) explore whether the impact persists through the end of the resident training, (3) evaluate the timing of the training within the existing curriculum to maximize its impact, (4) evaluate whether CBCT-informed interventions improve patient outcomes, and (5) explore chaplain and patient mediators of the impact of spiritual care consults on patient outcomes. Data acquired in this pilot study will be used to estimate efficacy and to inform a randomized controlled trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study aims to enroll 30 hospital chaplain residents, 15 will have the CBCT intervention early and the other 15 will learn about CBCT later. Additionally, 500 patients who have spiritual services provided by the chaplains participating in the study will be enrolled in order to examine patient outcomes.
| Arm | Type | Receives |
|---|---|---|
| Early-start group for CBCT-informed training | Experimental | Behavioral: CBCT-informed trainingHospital chaplain residents receiving the Cognitively-Based Compassion Training (CBCT) education during the first unit of their year-long residency. |
| Delayed-start group for CBCT-informed training | Active comparator | Behavioral: CBCT-informed trainingHospital chaplain residents receiving the Cognitively-Based Compassion Training (CBCT) education midway through their year-long residency. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Chaplain residents with Spiritual Health at Emory Healthcare
- Patient of Emory Healthcare
- Requested a spiritual health consultation with a hospital chaplain
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CBCT-informed trainingCognitively-Based Compassion Training (CBCT) is a secularized compassion meditation program adapted from the Tibetan Buddhist mind training (lojong) tradition. Lojong practices utilize a cognitive, analytic approach to challenge one's unexamined thoughts and emotions toward other people, with the long-term goal of developing altruistic emotions and behavior towards all people. | Behavioural | Delayed-start group for CBCT-informed training, Early-start group for CBCT-informed training |
Primary outcome
Change in Depression Anxiety and Stress Scale (DASS) Score
Time frame: Baseline, Week 5, Week 24, Week 29
The Depression Anxiety and Stress Scale (DASS) is a 42-item likert-scale measure that assesses the frequency of symptoms of depression, anxiety and stress during the past week. Respondents indicate the degree to which they agree with each statement on a scale of 0 to 3 where 0 = does not apply to me at all and 3 = applied to me very much, or most of the time. Total scores range from 0 to 126 and higher scores indicate increased feelings of depression, anxiety and stress.
Change in Mental Health Continuum Short Form (MHC-SF) Score
Time frame: Baseline, Week 5, Week 24, Week 29
The Mental Health Continuum Short Form (MHC-SF) is a 14-item inventory assessing emotional well-being. Participants indicate how frequently they have experienced different feelings (such as feeling happy) in the past month. Responses are are a 6-point scale where 0 = never and 5 = every day. Total scores range from 0 to 70 and higher scores indicate greater well being.
Change in Professional Quality of Life Scale (ProQOL) Score
Time frame: Baseline, Week 5, Week 24, Week 29
The Professional Quality of Life Scale (ProQOL) is a 30-item inventory, the ProQOL is the most commonly used measure of the negative and positive effects of helping others who experience suffering. It has sub-scales for compassion satisfaction, burnout, and compassion fatigue. The sub-scales are summed and converted to t-scores with a mean of 50 and standard deviation of 10. Scores higher than 57 indicate professional satisfaction while scores below 40 indicate possible problems with feeling satisfied professionally.
Change in School-Burnout Inventory (SBI) Score
Time frame: Baseline, Week 5, Week 24, Week 29
The School-Burnout Inventory is a 9-item survey asking students about how much burnout, in the context of an academic environment, they have felt in the past month (for example, "I feel overwhelmed by my schoolwork"). Respondents indicate the degree to which they agree with each statement on a scale of 1 to 6 where 1 = completely disagree and 6 = completely agree. Total scores can range from 9 to 54, with higher scores indicating more burnout.
Change in Revised University of California, Los Angeles (UCLA) Loneliness Scale (R-UCLA) Score
Time frame: Baseline, Week 5, Week 24, Week 29
The Revised UCLA Loneliness Scale (R-UCLA) is a 20-item questionnaire measuring general feelings of social isolation and dissatisfaction with one's social interactions. Participants rate each item on a scale from 1 (never) to 4 (often). When scoring the scale, certain items are reversed so that low scores correspond with low loneliness. Total scores range from 20 to 80, where high scores indicate high feelings of loneliness.
Change in Empathic Accuracy (EA) Task Score
Time frame: Baseline, Week 5, Week 24, Week 29
The Empathic Accuracy (EA) Task is a dynamic video assessment that asks subjects to continuously rate the emotions of others as they tell emotional autobiographical stories. Empathic accuracy is the correlation between feelings of the story-tellers in the video and what the participants perceive the story-tellers feelings to be.
Change in Spiritual Meaning Scale (SMS) Score
Time frame: Baseline, Week 5, Week 24, Week 29
The Spiritual Meaning Scale (SMS) is a 15-item, likert-scale inventory that assesses the extent to which someone endorses a belief in something larger than themselves. Participants respond to statements like "life is inherently meaningful" on a scale of 1 to 5 where 1 = I totally disagree, 3 = I'm in between, and 5 = I totally agree. Certain items are scored in reverse. The total score ranges from 15 to 75 and higher scores indicate stronger belief.
Change in Jefferson Scale of Empathy Score
Time frame: Baseline, Week 5, Week 24, Week 29
The Jefferson Scale of Empathy is a 20-item scale designed to measure empathy in practicing health care professionals and health care professional students. Participants answer on a 7-point scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 20 to 140 where higher scores indicate increased empathy.
8 secondary outcomes
National Comprehensive Cancer Network (NCCN) Distress Thermometer
Time frame: Day 1 (before Spiritual Health consult)
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Emotions
Time frame: Day 1 (after Spiritual Health consult)
PROMIS Positive Affect
Time frame: Day 1 (after Spiritual Health consult)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 1 (after Spiritual Health consult)
PROMIS Emotional Support
Time frame: Day 1 (after Spiritual Health consult)
PROMIS Informational Support
Time frame: Day 1 (after Spiritual Health consult)
PROMIS Social Isolation
Time frame: Day 1 (after Spiritual Health consult)
Scottish Patient Reported Outcome Measure (PROM)
Time frame: Day 1 (after Spiritual Health consult)
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 21 May 2020.
- Derived from this study: PubMed 40029890Mascaro JS, Palmer PK, Ash MJ, Florian MP, Kaplan DM, Palitsky R, Cole SP, Shelton M, Raison CL, Grant GH. A randomized controlled trial of a compassion-centered spiritual health intervention to improve hospital inpatient outcomes. PLoS One. 2025 Mar 3;20(3):e0313602. doi: 10.1371/journal.pone.0313602. eCollection 2025.
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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.
Jennifer Mascaro, PhD principal investigator
Emory University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBCT-informed training in people with Health Behavior, run by Emory University at 7 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 3 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 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Depression Anxiety and Stress Scale (DASS) Score (time frame: Baseline, Week 5, Week 24, Week 29). The study lists 8 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 NCT03529812, 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 21 May 2020.