CCSH (Compassion-Centered Spiritual Health) for Teams

NCT06722027 | Recruiting

• 2 other identifiers: STUDY000061091R34AT012509-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Emory Spiritual Health has developed a Compassion-Centered Spiritual Health group-based intervention, called CCSH Interventions for Teams, and are enrolling staff and providers into the groups in this randomized study design. The groups will meet once every other week for 60 minutes for 8 weeks (4 sessions total). The investigators will evaluate the feasibility and acceptability of this novel team-based intervention that includes mindfulness and compassion-based approaches with mixed-role oncology teams. Employees (n = 80; nurses, advanced practice providers (APPs), physicians, staff) working at an NCI- designated Comprehensive Cancer Center will be randomized by team (8-12 employees/group) to Compassion Centered Spiritual Health Team Intervention (CCSH-TI) or TAU (Treatment as Usual) group. The research objective is to evaluate the feasibility and acceptability of CCSH-TI, and to develop and validate a novel, low-burden ambulatory assessment "toolkit" to improve the measurement of psychological safety and burnout.

Conditions

Health Behavior

Keywords

Behavioral Intervention; Healthcare provider burnout

Outcome Measures

Primary Outcomes (9)

• Proportion of eligible employees who enroll and are willing to be randomized

  Proportion of eligible employees (all, and according to license, sex/gender, race/ethnicity) who enroll and are willing to be randomized.

  BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)

• Number of participants that attended and completed the three assessment timepoints

  Number of participants that attended and completed the three assessment timepoints

  BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)

• Retention rates at three assessment timepoints

  Retention rates will be assessed at three assessment timepoints

  BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)

• Satisfaction score

  The investigators will administer a satisfaction questionnaire that includes 5 questions. Total possible score ranges from 5-25. With higher score correlating with better study outcome.

  Immediately post-intervention (T2), and 12-weeks post-intervention (LT)

• Perceived credibility score

  The investigators will assess perceived credibility with a questionnaire that includes 5 questions. Each question is scores from 1 to 8 with a total possible score range of 5-40. Higher score correlates with better study outcome.

  Immediately post-intervention (T2), and 12-weeks post-intervention (LT)

• Perceived intervention benefit

  The investigators will assess perceived benefit with a questionnaire that includes 18 questions, to be answered with a 7-point scale. Total possible score ranges from 18 to 126. Higher score correlates with better study outcome.

  Immediately post-intervention (T2), and 12-weeks post-intervention (LT)

• Acceptability of wearing the Electronically Activated Recorder (EAR)

  After the T1, T2, and LT assessments, participants will complete the EAR Experiential Questionnaire, a self-report measure that assesses the acceptability of wearing the EAR. Questions focus on participants' comfort with wearing the EAR, whether the EAR impeded daily activities, whether the EAR changed their behaviors or others' behaviors, and how typical were the days that the EAR was worn. Each question is rated on a Likert scale (1 "not at all" - 5 "a great deal"). Higher score correlates with better outcome.

  BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)

• Number of EMA dropouts

  Number of EMA dropouts will be collected

  BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)

• Percentage (%) of items completed using EMA

  Percentage of items completed using EMA will be assessed.

  BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)

Secondary Outcomes (4)

• Change in Agency for Healthcare Research and Quality's TeamSTEPPS ® Teamwork Perceptions Questionnaire (T-TPQ) score

  BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)

• Change in Psychological safety scale score

  BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)

• Change in Professional Fulfillment Index Score

  BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)

• EMA (ecological momentary assessment) questionnaire score

  BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)

Study Arms (2)

CCSH-TI Group

EXPERIMENTAL

4-session intervention of 60- minutes each delivered every other week by healthcare chaplains to mixed-role inter-professional teams that includes mindfulness and compassion-based approaches to bolster resilience, compassion for self and others, and psychological safety.

Behavioral: Compassion Centered Spiritual Health Team Intervention (CCSH-TI)

TAU (treatment as usual) group

ACTIVE COMPARATOR

Participants in this group will have access to all well-being resources and activities available to them as employees.

Behavioral: Treatment as Usual

Interventions

Compassion Centered Spiritual Health Team Intervention (CCSH-TI) BEHAVIORAL

Delivered to healthcare teams by spiritual health clinicians proficient in group facilitation. It is composed of 4 sessions delivered every other week and lasting 60 minutes each. CCSH-TI sessions teach participants to attune to their interpersonal relationships; acknowledge and allow difficult emotions; and access compassion. It also provides psychoeducation about skillful coping strategies. Each session consists of didactic material about team norms and safety, a feeling check-in, facilitated group discussions about social connection and professional team building, and meditations to promote mindfulness, to cultivate a feeling of being nurtured, and to access compassion for self and others. CCSH-TI is delivered to healthcare teams by spiritual health clinicians proficient in group facilitation.

Also known as: CCSH-TI

CCSH-TI Group

Treatment as Usual BEHAVIORAL

TAU refers to the current buffet of wellness and professional development activities that are available to employees at the Winship Cancer Institute.

Also known as: TAU, Standard of Care

TAU (treatment as usual) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Full-time employees working in oncology teams at Winship Cancer Institute;
• Employees working in intensive care at Emory University St. Joseph hospital.

You may not qualify if:

• Less than 18 years old

Sponsors & Collaborators

• Emory University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University St. Joseph hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Related Publications (1)

• Giordano NA, Kaplan DM, Peacock C, Vyas I, Pozzo N, Shelton M, Escoffery C, Rana S, Raison CL, Grant GH, Mascaro JS. Protocol to examine the feasibility and acceptability of a randomized controlled trial of a chaplain-delivered compassion intervention to improve psychological safety among interprofessional healthcare teams. Pilot Feasibility Stud. 2025 Nov 13;11(1):141. doi: 10.1186/s40814-025-01712-7.

  PMID: 41258216 DERIVED

MeSH Terms

Conditions

Health Behavior

Interventions

Therapeutics; Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jennifer Mascaro, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Mascaro, PhD

CONTACT

404-558-4461; jmascar@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a longitudinal, randomized pilot study of 80 employees working in inter-professional oncologic teams. Employees will be randomized by team (using a random number generator in Microsoft Excel) to receive CCSH-TI or to a TAU "treatment as usual" (TAU) group.

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: September 24, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: The scientific dataset will be shared at the time of associated publications and will be made available for as long as it is useful to the larger research community (i.e., in perpetuity).
• Access Criteria: All individual-level data sets will be shared in openICPSR.

Locations

US (2)