NCT03720652

Brief Summary

Certified nursing assistants (CNAs), who provide the majority of care to persons with chronic disease and/or cognitive impairment from Alzheimer's disease and related dementias, face tremendous job and home stress, and as a result absenteeism and job turnover are high. This is a preliminary study that will tailor Mindful Self-Compassion (MSC) - a promising new program designed to cultivate greater self-care, and strengthen resilience and coping skills - for the CNA population and study its effectiveness. If results are favorable, MSC could be incorporated into CNA training programs, thereby helping contribute to a more effective and stable long-term care workforce.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 27, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2020

Completed
10 months until next milestone

Results Posted

Study results publicly available

April 29, 2021

Completed
Last Updated

April 29, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

October 24, 2018

Results QC Date

March 29, 2021

Last Update Submit

April 28, 2021

Conditions

Keywords

MindfulnessCertified Nursing AssistantsLong-Term CareStaff TurnoverMindful Self-Compassion

Outcome Measures

Primary Outcomes (1)

  • Study Participant's Self-Rating of Likelihood to Leave Job in the Coming Year Over Time

    The researchers will assess intent to leave job by asking "How likely is it that you will leave this job in the next year? "Would you say... 1 is Not at All Likely, 2 is Somewhat Likely, 3 is Very Likely." Minimum = 1 (best value), maximum = 3 (worst value). For the primary outcome analysis, intent will be evaluated by totaling the count of participants who responded "Somewhat Likely", "Very likely", or "Not at all likely." This was collected over the course of four time frames: Baseline, End-of Intervention interview, 3-Month Follow Up Interview, and 6-Month Follow Up Interview.

    Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months

Secondary Outcomes (20)

  • Change in Mean Score Over Time on Job Satisfaction Scale (JSS)

    Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months

  • Change in Mean Score Over Time on Approach to Dementia Questionnaire (ADQ) - Recognition of Personhood Subscale

    Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months

  • Change in Mean Score Over Time on Perceived Stress Scale (PSS)

    Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months

  • Change in Mean Score Over Time on PROMIS Depression Scale

    Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months

  • Change in Mean Score Over Time on Maslach Burnout Inventory (MBI) - Depersonalization Subscale

    Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months

  • +15 more secondary outcomes

Study Arms (2)

8-Week Mindful Self-Compassion (MSC)

EXPERIMENTAL

CNAs in Aim 1 will participate in the standardized, 8-week Mindful Self-Compassion course. Each 8-week session will last for 2.5 hours. Also included is a half day retreat, that CNAs may attend if they are able.

Behavioral: 8-Week Mindful Self-Compassion (MSC)

6-Week Mindful Self Compassion (MSC)

EXPERIMENTAL

CNAs from both nursing homes in Aim 2 will participate in the 6-week Mindful Self-Compassion course, that was shortened and customized to fit the needs of health care staff. Each 6-week session will last for 1 hour.

Behavioral: 6-Week Mindful Self-Compassion (MSC)

Interventions

The 8-week MSC is a course of eight 2.5 hour weekly sessions that is based off self-compassion, a construct closely related to mindfulness. Self-compassion (SC) has three main interrelated components: self-kindness, common humanity, and mindfulness. MSC is an 8-session program that integrates SC and mindfulness. It includes the following components: * Discovering Mindful Self-Compassion * Practicing Mindfulness * Practicing Lovingkindness * Discovering your Compassionate Voice * Living Deeply * Meeting Difficult Emotions * Exploring Challenging Relationships * Embracing Your Life

8-Week Mindful Self-Compassion (MSC)

The 6-week MSC is a course of six 1 hour weekly sessions that is based off self-compassion, a construct closely related to mindfulness. Self-compassion (SC) has three main interrelated components: self-kindness, common humanity, and mindfulness. MSC is an 6-session program that integrates SC and mindfulness. It includes the following components: * What is Self-Compassion * Practicing Self-Compassion * Discovering your Compassionate Voice * Self-Compassion and Resilience * Self-Compassion and Burnout * Going Forward This program is a shortened version of the 8-week program, specifically created for the needs of health care staff.

6-Week Mindful Self Compassion (MSC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Certified Nursing Assistant employed by one of 3 study Nursing Homes
  • Aged 18 and over
  • Speak English
  • Work at least 20 hours as a CNA at one of our proposed Nursing Homes
  • Expect to attend at least 75% of the intervention classes
  • Expect to stay at least the course of the intervention on the job
  • Score in the top 50% on the PSS-10 (Perceived Stress Scale) (if more than 20 participants interested)

You may not qualify if:

  • Younger than 18
  • Working fewer than 20 hours a week
  • Unable to attend at least 75% of the intervention classes
  • Expect to leave their position during the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (73)

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Related Links

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Results Point of Contact

Title
Philip D. Sloane, MD, MPH
Organization
University of North Carolina at Chapel Hill

Study Officials

  • Philip D Sloane, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: In Aim 1, the 8-week MSC program was conducted with nursing assistants from 1 nursing home to test for feasibility and practicality. After receiving feedback from participants of Aim 1, in Aim 2, the MSC program will be conducted in 2 nursing homes. Both nursing homes in Aim 2 will receive a shortened 6-week, 1 hour version specific to health care staff, in order to test the feasibility and practicality.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 25, 2018

Study Start

March 27, 2019

Primary Completion

June 2, 2020

Study Completion

June 23, 2020

Last Updated

April 29, 2021

Results First Posted

April 29, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be shared beginning 9 to 36 months following publication, and will be available for up to 7 years post publication.
Access Criteria
To access, interested parties will have to email Drs. Christine Lathren, lathren@email.unc.edu, and Philip D. Sloane, philip\ sloane@med.unc.edu, or contact the study team through the Cecil G. Sheps Center for Health Services Research at (919) 966-5011.

Locations