Health BehaviorNCT04060901
Compassion-Centered Spiritual Health for Faculty and Staff
A study testing CCSH Intervention for Teams in people with Health Behavior, run by Emory University at 1 site in United States.
Trial summary
Compassion-Centered Spiritual Health (CCSH) at Emory University was launched as a joint creation by Spiritual Health and the Center for Contemplative Science and Compassion-Based Ethics in 2018. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Behavior
- What is being tested?
- CCSH Intervention for Teams
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2019to 7 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emory staff, clinical research coordinators
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University, Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Compassion-Centered Spiritual Health (CCSH) Interventions for Teams With Faculty and Staff
Compassion-Centered Spiritual Health (CCSH) at Emory University was launched as a joint creation by Spiritual Health and the Center for Contemplative Science and Compassion-Based Ethics in 2018. The program enhances the practice of spiritual health through CCSH Interventions, which are a Cognitively-Based Compassion Training (CBCT)-based approach to support the practices of spiritual health clinicians. CBCT is a research-based contemplative program developed at Emory University in 2004. CCSH Interventions are provided by spiritual health clinicians across Emory's inpatient and outpatient facilities and beyond, and offer a method to alleviate distress in patients and families and to mitigate burnout in healthcare professionals. While the intervention will be required for some staff and provider populations, Spiritual Health proposes to pilot a voluntary systematic implementation of CCSH Interventions for Teams (CCSH-TI) to clinical research teams at Winship Cancer Institute. Clinical Research Coordinators (CRCs) experience significant emotional and spiritual burden through exposure to patients living with cancer and undergoing clinical trials for cancer treatment. As individuals and teams, CRCs face multiple work-related challenges known to cause distress, including experiences of secondary trauma, exposure to emotional and spiritual suffering of patients and families, and experiences of loss of patients. The researchers of this study hope that offering CCSH Interventions for Teams to CRCs will increase their resilience, wellbeing and compassion toward self and others, with a secondary benefit that burnout will be reduced. By conducting this pilot project, the researchers hope to gain a better understanding of how to optimally implement CCSH for CRC teams at the Winship Cancer Institute.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- CCSH Intervention for Teams
- Keywords
- Spiritual health clinician
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCSH Intervention for TeamsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CCSH Interventions for Teams in Cohort 1 | Experimental | Participants in the first cohort will receive the CCSH Interventions for Teams during the fall session (first intervention period). Receives: Behavioral: CCSH Intervention for Teams |
| CCSH Interventions for Teams in Cohort 2 | Experimental | Participants in the second cohort will receive the CCSH Interventions for Teams during the spring session (second intervention period). Receives: Behavioral: CCSH Intervention for Teams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Professional Quality of Life (ProQOL) Score
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.
Measured: Baseline, Week 5, Week 24, Week 29
Staff Retention
Staff retention (number of employees not resigning) will be compared between the teams completing the intervention and those who have not yet participated.
Measured: Up to Week 29
Staff Absenteeism
Staff absenteeism (number of missed work days) will be compared between the teams completing the intervention and those who have not yet participated.
Measured: Up to Week 29
Secondary outcomes (7)
Change in Depression Anxiety and Stress Scale (DASS) Short Form Score
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.
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 higher scores indicate increased feelings of loneliness.
Measured: Baseline, Week 5, Week 24, Week 29
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form Score
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.
Measured: Baseline, Week 5, Week 24, Week 29
Change in Connor-Davidson Resilience Scale 25 (CD-RISC-25) Score
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.
Measured: Baseline, Week 5, Week 24, Week 29
Change in Nursing Incivility Scale (General, Nurse, and Patient subscales)
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.
Measured: Baseline, Week 5, Week 24, Week 29
Interest in the CCSH Intervention Scale
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).
Measured: Baseline or Week 24
Experiences with the CCSH Intervention Scale
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.
Measured: Week 5 or Week 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start23 Aug 2019
- Primary completion7 Feb 2020
- Study completion7 Feb 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CRC teams will be randomized to one of two cohorts; the first cohort will receive the intervention during the first period while the second cohort waits to receive the intervention during the second period.
- Masking
- None (open label)
- Enrolment
- 58 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
- NCT04060901
- Sponsor's protocol ID
- IRB00112957
- Status last verified
- May 2020
- First submitted
- 16 Aug 2019
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mascaro JS, Palmer PK, Ash MJ, Peacock C, Sharma A, Escoffery C, Raison C. Feasibility, Acceptability, and Preliminary Effectiveness of a Compassion-Centered Team Intervention to Improve Clinical Research Coordinator Resilience and Well-Being. JCO Oncol Pract. 2021 Jul;17(7):e936-e946. doi: 10.1200/OP.21.00120. Epub 2021 Jun 21.
PubMed 34152835
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassion-Centered Spiritual Health (CCSH) Interventions for Teams With Faculty and Staff
- ClinicalTrials.gov ID
- NCT04060901
- Acronym / sponsor ID
- IRB00112957
- Conditions
- Health Behavior
- Keywords
- Spiritual health clinician
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 19 Aug 2019 (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.
Compassion-Centered Spiritual Health (CCSH) at Emory University was launched as a joint creation by Spiritual Health and the Center for Contemplative Science and Compassion-Based Ethics in 2018. The program enhances the practice of spiritual health through CCSH Interventions, which are a Cognitively-Based Compassion Training (CBCT)-based approach to support the practices of spiritual health clinicians. CBCT is a research-based contemplative program developed at Emory University in 2004. CCSH Interventions are provided by spiritual health clinicians across Emory's inpatient and outpatient facilities and beyond, and offer a method to alleviate distress in patients and families and to mitigate burnout in healthcare professionals. While the intervention will be required for some staff and provider populations, Spiritual Health proposes to pilot a voluntary systematic implementation of CCSH Interventions for Teams (CCSH-TI) to clinical research teams at Winship Cancer Institute. Clinical Research Coordinators (CRCs) experience significant emotional and spiritual burden through exposure to patients living with cancer and undergoing clinical trials for cancer treatment. As individuals and teams, CRCs face multiple work-related challenges known to cause distress, including experiences of secondary trauma, exposure to emotional and spiritual suffering of patients and families, and experiences of loss of patients. The researchers of this study hope that offering CCSH Interventions for Teams to CRCs will increase their resilience, wellbeing and compassion toward self and others, with a secondary benefit that burnout will be reduced. By conducting this pilot project, the researchers hope to gain a better understanding of how to optimally implement CCSH for CRC teams at the Winship Cancer Institute.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- CRC teams will be randomized to one of two cohorts; the first cohort will receive the intervention during the first period while the second cohort waits to receive the intervention during the second period.
| Arm | Type | Receives |
|---|---|---|
| CCSH Interventions for Teams in Cohort 1 | Experimental | Behavioral: CCSH Intervention for TeamsParticipants in the first cohort will receive the CCSH Interventions for Teams during the fall session (first intervention period). |
| CCSH Interventions for Teams in Cohort 2 | Experimental | Behavioral: CCSH Intervention for TeamsParticipants in the second cohort will receive the CCSH Interventions for Teams during the spring session (second intervention period). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Emory staff, clinical research coordinators
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 |
|---|---|---|
| CCSH Intervention for TeamsCCSH 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. | Behavioural | CCSH Interventions for Teams in Cohort 1, CCSH Interventions for Teams in Cohort 2 |
Primary outcome
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.
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.
Staff Absenteeism
Time frame: Up to Week 29
Staff absenteeism (number of missed work days) will be compared between the teams completing the intervention and those who have not yet participated.
7 secondary outcomes
Change in Depression Anxiety and Stress Scale (DASS) Short Form Score
Time frame: Baseline, Week 5, Week 24, Week 29
Change in Revised University of California, Los Angeles (UCLA) Loneliness Scale (R-UCLA) Score
Time frame: Baseline, Week 5, Week 24, Week 29
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form Score
Time frame: Baseline, Week 5, Week 24, Week 29
Change in Connor-Davidson Resilience Scale 25 (CD-RISC-25) Score
Time frame: Baseline, Week 5, Week 24, Week 29
Change in Nursing Incivility Scale (General, Nurse, and Patient subscales)
Time frame: Baseline, Week 5, Week 24, Week 29
Interest in the CCSH Intervention Scale
Time frame: Baseline or Week 24
Experiences with the CCSH Intervention Scale
Time frame: Week 5 or Week 29
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 14 May 2020.
- Derived from this study: PubMed 34152835Mascaro JS, Palmer PK, Ash MJ, Peacock C, Sharma A, Escoffery C, Raison C. Feasibility, Acceptability, and Preliminary Effectiveness of a Compassion-Centered Team Intervention to Improve Clinical Research Coordinator Resilience and Well-Being. JCO Oncol Pract. 2021 Jul;17(7):e936-e946. doi: 10.1200/OP.21.00120. Epub 2021 Jun 21.
- 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.
Jennifer Mascaro, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCSH Intervention for Teams in people with Health Behavior, run by Emory University at 1 site 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 1 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 14 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 1 site 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 Professional Quality of Life (ProQOL) Score (time frame: Baseline, Week 5, Week 24, Week 29). The study lists 3 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 NCT04060901, 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 14 May 2020.