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CBCT for Spiritual Health Clinicians

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529812
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Jennifer Mascaro, Emory University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: CBCT-informed training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Exploring the Effect of Cognitively-Based Compassion Training (CBCT) on the Empathic Accuracy and Resilience of Spiritual Health Clinicians
Actual Study Start Date : July 5, 2018
Actual Primary Completion Date : May 7, 2020
Actual Study Completion Date : May 7, 2020

Arm Intervention/treatment
Experimental: Early-start group for CBCT-informed training
Hospital chaplain residents receiving the Cognitively-Based Compassion Training (CBCT) education during the first unit of their year-long residency.
Behavioral: CBCT-informed training
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.

Active Comparator: Delayed-start group for CBCT-informed training
Hospital chaplain residents receiving the Cognitively-Based Compassion Training (CBCT) education midway through their year-long residency.
Behavioral: CBCT-informed training
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Secondary Outcome Measures :
  1. National Comprehensive Cancer Network (NCCN) Distress Thermometer [ Time Frame: Day 1 (before Spiritual Health consult) ]
    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.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Emotions [ Time Frame: Day 1 (after Spiritual Health consult) ]
    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.

  3. PROMIS Positive Affect [ Time Frame: Day 1 (after Spiritual Health consult) ]
    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.

  4. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Day 1 (after Spiritual Health consult) ]
    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.

  5. PROMIS Emotional Support [ Time Frame: Day 1 (after Spiritual Health consult) ]
    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.

  6. PROMIS Informational Support [ Time Frame: Day 1 (after Spiritual Health consult) ]
    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.

  7. PROMIS Social Isolation [ Time Frame: Day 1 (after Spiritual Health consult) ]
    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.

  8. Scottish Patient Reported Outcome Measure (PROM) [ Time Frame: Day 1 (after Spiritual Health consult) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Chaplains:

  • Chaplain residents with Spiritual Health at Emory Healthcare

Inclusion Criteria for Chaplains:

  • Patient of Emory Healthcare
  • Requested a spiritual health consultation with a hospital chaplain

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529812


Locations
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United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Wesley Woods Center
Atlanta, Georgia, United States, 30329
St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
Emory Johns Creek Hospital
Johns Creek, Georgia, United States, 30097
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Jennifer Mascaro, PhD Emory University
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Responsible Party: Jennifer Mascaro, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03529812    
Other Study ID Numbers: IRB00098222
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Mascaro, Emory University:
Behavioral intervention
Social intervention