NCT03529812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 5, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2020

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

May 8, 2018

Last Update Submit

May 19, 2020

Conditions

Keywords

Behavioral interventionSocial intervention

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline, Week 5, Week 24, Week 29

Secondary Outcomes (8)

  • National Comprehensive Cancer Network (NCCN) Distress Thermometer

    Day 1 (before Spiritual Health consult)

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Emotions

    Day 1 (after Spiritual Health consult)

  • PROMIS Positive Affect

    Day 1 (after Spiritual Health consult)

  • Hospital Anxiety and Depression Scale (HADS)

    Day 1 (after Spiritual Health consult)

  • PROMIS Emotional Support

    Day 1 (after Spiritual Health consult)

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: CBCT-informed training

Interventions

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.

Delayed-start group for CBCT-informed trainingEarly-start group for CBCT-informed training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chaplain residents with Spiritual Health at Emory Healthcare
  • Patient of Emory Healthcare
  • Requested a spiritual health consultation with a hospital chaplain

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Wesley Woods Center

Atlanta, Georgia, 30329, United States

Location

St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jennifer Mascaro, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 18, 2018

Study Start

July 5, 2018

Primary Completion

May 7, 2020

Study Completion

May 7, 2020

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations