Certified Nursing Assistants' Wellbeing (CNA)

Mindful Self-Compassion Training to Improve Retention, Job Satisfaction, and Attitudes Toward Dementia Among Long-Term Care Nursing Assistants

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.

Study Overview

Detailed Description

U.S. nursing homes (NHs) serve 1.6 million older persons, all of whom have significant physical and/or cognitive impairment, and the majority of whom have Alzheimer's disease or a related cognitive disorder. In these settings the vast majority of hands-on care is provided by an estimated 634,000 certified nursing assistants (CNAs) - paraprofessional caregivers who are racially diverse, largely female, and an annual income equivalent to the poverty threshold for a family of four. Despite the crucial role of CNAs in providing care for the long-term care population and efforts to recruit and retain a stable workforce, absenteeism rates are high and annual turnover averages 65%, with adverse impact on the quality of care provided to NH residents, making CNA retention a policy priority.

CNAs have significant life stressors that affect their ability to work, such as single parenthood, poor physical health, difficulty finding childcare, and transportation problems. They also face emotionally and physically demanding job tasks, particularly when working with persons with Alzheimer's disease and related dementias, and many lack helpful strategies for dealing with stress, negative feelings, and burden.

A newly developed, standardized Mindful Self-Compassion (MSC) intervention may have particularly high impact and relevance for the high-stress lives of NH CNAs. MSC training has been shown to increase wellbeing, compassion for others, and stress-coping skills. However, little is known about the impact, feasibility and acceptability of MSC training in low-educated, stress-burdened paraprofessional populations such as CNAs, or whether it can impact outcomes such as burnout, absenteeism, and turnover.

This preliminary study will modify, refine, and test a MSC training intervention for CNAs, to be known as the CNA Wellbeing Program, who care for nursing home residents. The researcher teams' goal is to increase CNA coping skills and well-being, thereby reducing intent to leave the job, reducing burnout, and improving job satisfaction and attitudes toward people with dementia. The proposed research will be conducted in 3 similarly rated and structured community NHs. In Aim 1 the investigators will assess intervention feasibility and acceptability in one NH, using the knowledge they gain to tailor an evidence-based MSC program specifically for CNAs. In Aim 2 the investigators will pilot test the MSC training program with 30 CNAs who work in 2 similarly rated and structured NHs, evaluating the fidelity of the revised training and exploring trends in immediate, 3-month, and 6-month outcome measures in order to inform power calculations for future trials.

The specific aims are:

Aim 1. Determine the feasibility, acceptability, and necessary adaptations of MSC training needed to meet the diverse cultural background, limited literacy, and job and family challenges of the nursing home CNA workforce, including the unique challenges of caring for persons with dementia, and of the data collection methods.

  1. Conduct a field trial of the standardized 8-week MSC training program with 15 CNAs within a single community NH. Evaluation will focus on: (a) participation (including home practice adherence); (b) attendee evaluation of the training; (c) barriers to and facilitators of participation; (d) use and retention of class material by participants; and (e) recommendations for improvement of training.
  2. Field test the feasibility and acceptability of our study recruitment and evaluation strategy.
  3. Use data collected from the field test to modify recruitment strategies, protocols, and course structure, content and materials so as to be maximally feasible, acceptable and effective in a CNA population.

Aim 2. Conduct a pilot test of the adapted protocols and intervention in a sample of 30 CNAs from 2 similarly rated and structured community NHs to reexamine feasibility and acceptability, identify trends in key intermediate and long-term outcomes, and estimate effect size in preparation for a future randomized trial.

  1. Evaluate the fidelity and immediate impact of the modified training by measuring (a) training attendance; (b) satisfaction with the training; and (c) pre-and post-training measures of self-compassion, perceived stress, job satisfaction, job burnout symptoms, and attitudes towards persons with dementia.
  2. Evaluate the sustained impact of the training by comparing baseline, 3-and 6-month post-training measurements of: intent to leave job, self-compassion, perceived stress, job satisfaction, job burnout symptoms, and attitudes towards persons with dementia.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University Of North Carolina At Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 8-Week Mindful Self-Compassion (MSC)
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.

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
Experimental: 6-Week Mindful Self Compassion (MSC)
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Participant's Self-Rating of Likelihood to Leave Job in the Coming Year Over Time
Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Score Over Time on Job Satisfaction Scale (JSS)
Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Job satisfaction will be assessed using the 3-item Job Satisfaction scale (JSS). Responses are provided using a 7-point Likert scale measuring how satisfied respondents are with their job. Minimum score = 0 (worst value). Maximum score = 6 (best value). Range of scores from 0 to 18, with higher values indicating better outcomes. Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 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
Change in Mean Score Over Time on Approach to Dementia Questionnaire (ADQ) - Recognition of Personhood Subscale
Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Approach to Dementia Questionnaire (ADQ) - Recognition of Personhood Subscale is an 11-item instrument. Responses are indicated using a 5-point Likert scale. Minimum score (worst value) = 1. Maximum score (best value) = 5. Higher values represent a better outcome (range 11-55). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 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
Change in Mean Score Over Time on Perceived Stress Scale (PSS)
Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Perceived Stress Scale (PSS) 10-item version. Perceived stress is defined as the degree to which individuals find their lives "unpredictable, uncontrollable, and overloading". Responses are indicated using a 5-point Likert scale. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome (range 0 - 40). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 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
Change in Mean Score Over Time on PROMIS Depression Scale
Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
PROMIS Emotional Distress Depression - Short Form (PROMIS) is an 8-item instrument. Responses are indicated using a 5-point Likert scale. Minimum score (best value) = 1/Never. Maximum score (worst value) = 5/Always. Lower values represent a better outcome (range 8-40). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
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
Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Burnout will be assessed via a modified Maslach Burnout Inventory (MBI) - Depersonalization Subscale (one of three subscales within the MBI), a 5-item scale. Items are measured on a 7-point Likert scale that asks how often respondents are feeling certain feelings. Minimum score (best value, never) = 0. Maximum score (worst value, every day) = 6. Analysis reports mean score rather than total score; range of the mean score is 0 to 6, with lower values representing better outcomes. Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
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) - Emotional Exhaustion Subscale
Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Burnout will be assessed via a modified Maslach Burnout Inventory (MBI) - Emotional Exhaustion Subscale (one of three subscales within the MBI), a 8-item scale. Items are measured on a 7-point Likert scale that asks how often respondents are feeling certain feelings. Minimum score (best value, never) = 0. Maximum score (worst value, every day) = 6. Analysis reports mean score rather than total score; range of the mean score is 0 to 6, with lower values representing better outcomes. Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 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
Change in Mean Score Over Time on Maslach Burnout Inventory (MBI) - Personal Accomplishment Subscale
Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Burnout will be assessed via a modified Maslach Burnout Inventory (MBI) - Personal Accomplishment Subscale (one of three subscales within the MBI), a 7-item scale. Items are measured on a 7-point Likert scale that asks how often respondents are feeling certain feelings. Minimum score (worst value, never) = 0. Maximum score (best value, every day) = 6. Analysis reports mean score rather than total score; range of the mean score is 0 to 6, with higher values representing better outcomes. Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
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 Self-compassion Scale-Short Form (SCS-SF)
Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF), a 12-item scale that includes the three components of self-compassion: self-kindness, common humanity, and mindfulness. This is done using a 5-point Likert scale. Minimum score = 1 (worst value). Maximum score = 5 (best value). Analysis reports mean score rather than total score (total range is 0.0 to 5.0), with higher values indicating better outcomes. Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 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
Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) - Self-kindness Subscale
Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Self-kindness Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (worst value). Maximum score = 5 (best value), higher scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
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 Self-compassion Scale-Short Form (SCS-SF) - Self-judgment Subscale
Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Self-judgment Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (best value). Maximum score = 5 (worst value), with lower scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
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 Self-compassion Scale-Short Form (SCS-SF) - Common Humanity Subscale
Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Common humanity Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (worst value). Maximum score = 5 (best value), with higher scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
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 Self-compassion Scale-Short Form (SCS-SF) - Isolation Subscale
Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Isolation Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (best value). Maximum score = 5 (worst value), with lower scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
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 Self-compassion Scale-Short Form (SCS-SF) - Mindfulness Subscale
Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Mindfulness Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (worst value). Maximum score = 5 (best value), with higher scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
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 Self-compassion Scale-Short Form (SCS-SF) - Over-identification Subscale
Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Over-identification Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (best value). Maximum score = 5 (worst value), with lower scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Percent of Classes Attended by Participating CNAs
Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6-8 weeks
This will be reported as percent of classes attended by CNAs.
Participants will be followed for the duration of the intervention, an expected average of 6-8 weeks
Percent of Participants Attending All Intervention Sessions
Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6-8 weeks
This will be reported by percent of participants who attended every assigned intervention session (6 or 8 depending on intervention arm).
Participants will be followed for the duration of the intervention, an expected average of 6-8 weeks
Percent Intervention Minutes Attended by Participants
Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6-8 weeks
This will be collected by recording the number of minutes each participant spent per class in order to account for intervention missed due to participants' leaving early or coming late, and reporting percent of minutes attended by participants.
Participants will be followed for the duration of the intervention, an expected average of 6-8 weeks
Mean Number of Days Per Week Spent in Out-of-Class Informal Exercise
Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6/8 weeks
Based on participant completion of weekly surveys, the researchers will measure the number of days each week that class participants were able to practice learned informal techniques and exercises outside of class hours.
Participants will be followed for the duration of the intervention, an expected average of 6/8 weeks
Mean Number of Days Per Week Spent in Out-of-Class Formal Exercise
Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6/8 weeks
Based on participant completion of weekly surveys, the researchers will measure the number of days each week that class participants were able to practice learned formal techniques and exercises outside of class hours.
Participants will be followed for the duration of the intervention, an expected average of 6/8 weeks
Study Participant's Self-Rating of Satisfaction With the MSC Course
Time Frame: At the conclusion of the week 6/8 class, during the End-of-Intervention Interview, participants were asked their satisfaction with the course
The researchers assess satisfaction of the MSC training using an 8-item, 5-point Likert Scale (0 = Strongly Disagree, 1 = Disagree, 2 = Neither Agree nor Disagree, 3 = Agree, 4 = Strongly Agree). Minimum = 0 (worst value), maximum = 4 (best value). Measure was assessed during the End-of-Intervention Interview.
At the conclusion of the week 6/8 class, during the End-of-Intervention Interview, participants were asked their satisfaction with the course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Philip D Sloane, MD, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2019

Primary Completion (Actual)

June 2, 2020

Study Completion (Actual)

June 23, 2020

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 18-2012
  • 1R21AG058133-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Stress and Burnout

Clinical Trials on 8-Week Mindful Self-Compassion (MSC)

3
Subscribe