- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04060901
Compassion-Centered Spiritual Health for Faculty and Staff
Compassion-Centered Spiritual Health (CCSH) Interventions for Teams With Faculty and Staff
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Previous research indicates that Cognitively-Based Compassion Training (CBCT) improves empathic accuracy, enhances well-being, and attenuates the pro-inflammatory response to psychosocial stress. CBCT is a secularized compassion meditation program adapted from the Tibetan Buddhist mind training (lojong) tradition, and it may be an ideal addendum to the spiritual caregiving provided by Emory University hospital chaplains and chaplain residents to approximately 100,000 patients, staff, and faculty members each year.
With this in mind, The Emory University Spiritual Health department now incorporates CBCT into their training curriculum using a phased approach that began in Fall 2017. The Spiritual Health department also developed an adapted program based on CBCT principles that chaplains can then deliver to patients and staff, called Compassion-Centered Spiritual Health (CCSH). Spiritual Health proposes to pilot a systematic implementation of CCSH Interventions for Teams (CCSH-TI) to clinical research teams at the Winship Cancer Institute.
This is a randomized trial of CCSH Interventions for Teams versus a wait list control condition. CRC teams will be randomized to receive CCSH-TI during a first cohort or to a wait-list group that will receive CCSH-TI during the second cohort. CRCs (n = 93) will be randomized by team to receive CCSH Interventions for Teams either in the fall or in the spring. Participating CRCs will complete self-report measures at 4 timepoints throughout the year: (1) Prior to randomization, (2) immediately upon completion of CCSH Interventions for Teams for cohort 1 (3) prior to CCSH Interventions for Teams for cohort 2, and (4) immediately upon completion of CCSH Interventions for Teams for cohort 2.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University, Winship Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Emory staff, clinical research coordinators
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: CCSH Interventions for Teams in Cohort 1
Participants in the first cohort will receive the CCSH Interventions for Teams during the fall session (first intervention period).
|
CCSH Interventions for Teams will be a six session intervention. The groups meet once per week for 60 minutes for 4 weeks, coupled with 2 booster sessions over the following 2 months. Participants will receive the CCSH interventional approach, adapted for a group setting, which follows four stages: 1) Preparing the care responder; 2) Attuning to the Relationship; 3) Accessing Compassion, and 4) Entrusting the Careseeker. The CCSH approach will be used to assess group dynamics, individual member sources of distress, as well as existing resources for resilience and compassion. Through the intervention, resources will then be identified and accessed in order to respond to team (and individual) sources of distress with greater resilience and increased compassion toward self and others. CCSH clinicians will utilize group process skills to encourage team communication about work-related challenges, enhance team cohesion, and enable interpersonal support among members of the team. |
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EXPERIMENTAL: CCSH Interventions for Teams in Cohort 2
Participants in the second cohort will receive the CCSH Interventions for Teams during the spring session (second intervention period).
|
CCSH Interventions for Teams will be a six session intervention. The groups meet once per week for 60 minutes for 4 weeks, coupled with 2 booster sessions over the following 2 months. Participants will receive the CCSH interventional approach, adapted for a group setting, which follows four stages: 1) Preparing the care responder; 2) Attuning to the Relationship; 3) Accessing Compassion, and 4) Entrusting the Careseeker. The CCSH approach will be used to assess group dynamics, individual member sources of distress, as well as existing resources for resilience and compassion. Through the intervention, resources will then be identified and accessed in order to respond to team (and individual) sources of distress with greater resilience and increased compassion toward self and others. CCSH clinicians will utilize group process skills to encourage team communication about work-related challenges, enhance team cohesion, and enable interpersonal support among members of the team. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Professional Quality of Life (ProQOL) Score
Time Frame: Baseline, Week 5, Week 24, Week 29
|
The Professional Quality of Life Scale (ProQOL) is a 30-item inventory and 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
|
|
Staff Retention
Time Frame: Up to Week 29
|
Staff retention (number of employees not resigning) will be compared between the teams completing the intervention and those who have not yet participated.
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Up to Week 29
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Staff Absenteeism
Time Frame: Up to Week 29
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Staff absenteeism (number of missed work days) will be compared between the teams completing the intervention and those who have not yet participated.
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Up to Week 29
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Depression Anxiety and Stress Scale (DASS) Short Form Score
Time Frame: Baseline, Week 5, Week 24, Week 29
|
The Depression Anxiety and Stress Scale (DASS) short form is a 21-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 63 and higher scores indicate increased feelings of depression, anxiety and stress.
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Baseline, Week 5, Week 24, Week 29
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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 higher scores indicate increased feelings of loneliness.
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Baseline, Week 5, Week 24, Week 29
|
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form Score
Time Frame: Baseline, Week 5, Week 24, Week 29
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The PROMIS Sleep Disturbance Short Form is an 8-item scale assessing self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep.
This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep.
Responses are given on a 5-point scale where 1 = no problems and 5 = very problematic.
Total raw scores range from 8 to 40 where higher scores indicate greater sleep disturbances.
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Baseline, Week 5, Week 24, Week 29
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Change in Connor-Davidson Resilience Scale 25 (CD-RISC-25) Score
Time Frame: Baseline, Week 5, Week 24, Week 29
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The CD-RISC-25 is a 25-item inventory measuring resilience.
Responses are on a 5-point scale where 0 = rarely true and 4 = true nearly all of the time.
Total scores range from 0 to 100 and higher scores indicate greater resilience.
|
Baseline, Week 5, Week 24, Week 29
|
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Change in Nursing Incivility Scale (General, Nurse, and Patient subscales)
Time Frame: Baseline, Week 5, Week 24, Week 29
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The Workplace Incivility Scale is a 43-item instrument assessing perceived disrespect, condescension, or degradation in the healthcare environment.
Responses are on a 5-point scale where 1 = strongly disagree and 5 = strongly agree.
Total scores for the 3 subscales used here range from 0 to 116 and higher scores indicate greater perceived incivility in the workplace.
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Baseline, Week 5, Week 24, Week 29
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Interest in the CCSH Intervention Scale
Time Frame: Baseline or Week 24
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Prior to beginning the CCSH intervention, participants will complete a 6-item questionnaire assessing their interest in learning CBCT.
Responses are given on a 7-point scale where 7-point scale where 0 = strongly disagree and 6 = strongly agree.
Total scores range from 0 to 36 with higher scores indicating greater interest in the intervention.
Participants in Cohort 1 will complete the questionnaire at the Baseline visit and participants in Cohort 2 will complete this questionnaire at the Week 24 visit (prior to beginning the second session of the intervention).
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Baseline or Week 24
|
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Experiences with the CCSH Intervention Scale
Time Frame: Week 5 or Week 29
|
Upon completion of the CCSH intervention the participant's experiences with the intervention will be assessed with a 7-item scale asking questions about how beneficial the intervention was.
Responses are given on a 7-point scale where 0 = strongly disagree and 6 = strongly agree.
Total scores range from 0 to 42 with higher scores indicating greater satisfaction with the intervention.
Participants in Cohort 1 will complete the questionnaire at the Week 5 visit and participants in Cohort 2 will complete this questionnaire at the Week 29 visit.
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Week 5 or Week 29
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00112957
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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