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Health BehaviorNCT06722027

CCSH (Compassion-Centered Spiritual Health) for Teams

A study testing Compassion Centered Spiritual Health Team Intervention (CCSH-TI) and Treatment as Usual in people with Health Behavior, run by Emory University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). 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?
Compassion Centered Spiritual Health Team Intervention (CCSH-TI) and Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesUnited States
Study dates
24 Sep 2025to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

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

Who cannot join

  • Less than 18 years old

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Mascaro, PhD contact

404-558-4461

jmascar@emory.edu

United States2 sites, 2 recruiting
  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

    Recruiting
  • Emory University St. Joseph hospital

    Atlanta, Georgia, 30342

    Recruiting

Other trials in United States

About this study

Official title: Compassion-Centered Spiritual Health Interventions for Teams (CCSH-TI) With Faculty and Staff

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.

Read the detailed description

Current interventions to reduce provider burnout are only minimally effective. To overcome the barriers to achieving success in burnout prevention interventions, the investigators propose Compassion Centered Spiritual Health Team Intervention (CCSH-TI), a 4-session intervention delivered by healthcare chaplains to mixed-role interprofessional teams that includes mindfulness and compassion-based approaches to bolster resilience, compassion for self and others, and psychological safety. The research team will conduct a mixed-method feasibility and acceptability study of CCSH-TI 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 CCSH-TI or to TAU (Treatment as Usual) group, who has access to all well-being resources and activities available to them as employees. Self-report surveys and focus group discussions will be used to evaluate the feasibility and acceptability of CCSH-TI. The investigators will also collect self-report surveys, ecological momentary assessments (EMA), and the electronically activated recorder (EAR) data at 3 timepoints (before CCSH-TI (T1), immediately after completion of CCSH-TI (T2), and 12-weeks after completion (LT), and characterize data completion to evaluate the feasibility of data collection methods for a future randomized control trial. Informed consent will be obtained from study participants in-person. The duration of the study will be 22-23 weeks (from consent to completion of data collection).

Conditions
Health Behavior
Being tested
Compassion Centered Spiritual Health Team Intervention (CCSH-TI), Treatment as Usual
Keywords
Behavioral Intervention, Healthcare provider burnout
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compassion Centered Spiritual Health Team Intervention (CCSH-TI)Behavioural

    Also called CCSH-TI

    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.

  • Treatment as UsualBehavioural

    Also called TAU, Standard of Care

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

Study groups in NCT06722027
Study groupRoleWhat they receive
CCSH-TI GroupExperimental4-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.
Receives: Behavioral: Compassion Centered Spiritual Health Team Intervention (CCSH-TI)
TAU (treatment as usual) groupActive comparatorParticipants in this group will have access to all well-being resources and activities available to them as employees.
Receives: Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Number of participants that attended and completed the three assessment timepoints

    Number of participants that attended and completed the three assessment timepoints

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

  3. Retention rates at three assessment timepoints

    Retention rates will be assessed at three assessment timepoints

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. Number of EMA dropouts

    Number of EMA dropouts will be collected

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

  9. Percentage (%) of items completed using EMA

    Percentage of items completed using EMA will be assessed.

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

Secondary outcomes (4)
  1. Change in Agency for Healthcare Research and Quality's TeamSTEPPS ® Teamwork Perceptions Questionnaire (T-TPQ) score

    Measures perceptions of team function with the administration of the Team Structure and Mutual Support subscales (14 items total). Total possible score ranges from 1-14 with higher scores indicating better outcome.

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

  2. Change in Psychological safety scale score

    Includes subscales measuring psychological safety with leaders, peers, and within the team (19 items). Total possible score ranges from 1-19 with higher scores indicating better outcome.

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

  3. Change in Professional Fulfillment Index Score

    Measures Professional fulfillment and burnout, and has demonstrated sensitivity to change in intervention studies (16 items). Total possible score ranges from 1-16 with higher scores indicating better outcome.

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

  4. EMA (ecological momentary assessment) questionnaire score

    The 3-day ambulatory questionnaire asks participants whether the ecological momentary assessment (EMA) impeded daily activities or changed their behaviors, rated on a Likert scale (1 "not at all" - 5 "a great deal"). Higher score correlates with better outcome.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2024
  2. Study start24 Sep 2025
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06722027
Sponsor's protocol ID
STUDY00006109
Other IDs
1R34AT012509-01A1
Status last verified
Apr 2026
First submitted
3 Dec 2024
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The research team will share the molar and behavioral codebooks by uploading them to the Open Science Framework (OSF) EAR Repository, a publicly asses-sable collaborative repository of EAR, a resource co-maintained by a member of the research team (Kaplan). The investigator will share summarized rates of accrual, retention, intervention attendance, and self-reported data (mean, standard deviation, and range) at all 3 time-points. Access will not be controlled or monitored; it will be made available by the data repository based on approval guidelines maintained by the repository itself. Privacy and confidentiality will be protected using de-identification of all individual-level data. Audio recordings and transcripts will not be shared so as to maintain participant privacy.

Publications

  • 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.

    PubMed 41258216

Questions about this trial

What is this clinical trial studying?

A study testing Compassion Centered Spiritual Health Team Intervention (CCSH-TI) and Treatment as Usual in people with Health Behavior, run by Emory University at 2 sites 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 2 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Mascaro, PhD (404-558-4461, jmascar@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of eligible employees who enroll and are willing to be randomized (time frame: BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)). The study lists 9 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 NCT06722027, 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 5 May 2026.

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