Stress and BurnoutCNANCT03720652
Certified Nursing Assistants' Wellbeing
A study testing 8-Week Mindful Self-Compassion (MSC) and 6-Week Mindful Self-Compassion (MSC) in people with Stress and Burnout, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress and Burnout
- What is being tested?
- 8-Week Mindful Self-Compassion (MSC) and 6-Week Mindful Self-Compassion (MSC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2019to 23 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
Read the 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.
- 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.
- Field test the feasibility and acceptability of our study recruitment and evaluation strategy.
- 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.
- 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.
- 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.
- Conditions
- Stress and Burnout
- Being tested
- 8-Week Mindful Self-Compassion (MSC), 6-Week Mindful Self-Compassion (MSC)
- Keywords
- Mindfulness, Certified Nursing Assistants, Long-Term Care, Staff Turnover, Mindful Self-Compassion
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-Week Mindful Self-Compassion (MSC)Behavioural
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
6-Week Mindful Self-Compassion (MSC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: 6-Week Mindful Self-Compassion (MSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
This will be reported as percent of classes attended by CNAs.
Measured: Participants will be followed for the duration of the intervention, an expected average of 6-8 weeks
Percent of Participants Attending All Intervention Sessions
This will be reported by percent of participants who attended every assigned intervention session (6 or 8 depending on intervention arm).
Measured: Participants will be followed for the duration of the intervention, an expected average of 6-8 weeks
Percent Intervention Minutes Attended by Participants
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At the conclusion of the week 6/8 class, during the End-of-Intervention Interview, participants were asked their satisfaction with the course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start27 Mar 2019
- Primary completion2 Jun 2020
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (73)Papers the sponsor has linked to this study.
- Other trials for Stress and BurnoutStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Philip D Sloane, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720652
- Sponsor's protocol ID
- 18-2012
- Other IDs
- 1R21AG058133-01A1
- Acronym
- CNA
- Status last verified
- Mar 2021
- First submitted
- 24 Oct 2018
- Last updated
- 29 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Jones AL, Dwyer LL, Bercovitz AR, Strahan GW. The National Nursing Home Survey: 2004 overview. Vital Health Stat 13. 2009 Jun;(167):1-155.
PubMed 19655659Barbarotta L. Direct Care Worker Retention: Strategies for Success.; 2010.
Castle NG, Ferguson-Rome JC. Influence of Nurse Aide Absenteeism on Nursing Home Quality. Gerontologist. 2015 Aug;55(4):605-15. doi: 10.1093/geront/gnt167. Epub 2014 Jan 7.
PubMed 24398653Castle NG, Engberg J, Men A. Nursing home staff turnover: impact on nursing home compare quality measures. Gerontologist. 2007 Oct;47(5):650-61. doi: 10.1093/geront/47.5.650.
PubMed 17989407Lerner NB, Johantgen M, Trinkoff AM, Storr CL, Han K. Are nursing home survey deficiencies higher in facilities with greater staff turnover. J Am Med Dir Assoc. 2014 Feb;15(2):102-7. doi: 10.1016/j.jamda.2013.09.003. Epub 2013 Oct 15.
PubMed 24139163Trinkoff AM, Han K, Storr CL, Lerner N, Johantgen M, Gartrell K. Turnover, staffing, skill mix, and resident outcomes in a national sample of US nursing homes. J Nurs Adm. 2013 Dec;43(12):630-6. doi: 10.1097/NNA.0000000000000004.
PubMed 24232236Cook G, Brown-Wilson C. Care home residents' experiences of social relationships with staff. Nurs Older People. 2010 Feb;22(1):24-9. doi: 10.7748/nop2010.02.22.1.24.c7492.
PubMed 20225727Squillace MR, Remsburg RE, Harris-Kojetin LD, Bercovitz A, Rosenoff E, Han B. The National Nursing Assistant Survey: improving the evidence base for policy initiatives to strengthen the certified nursing assistant workforce. Gerontologist. 2009 Apr;49(2):185-97. doi: 10.1093/geront/gnp024. Epub 2009 Apr 1.
PubMed 19363014Dill JS, Morgan JC, Marshall VW, Pruchno R. Contingency, employment intentions, and retention of vulnerable low-wage workers: an examination of nursing assistants in nursing homes. Gerontologist. 2013 Apr;53(2):222-34. doi: 10.1093/geront/gns085. Epub 2012 Aug 8.
PubMed 22875015Lachs MS, Rosen T, Teresi JA, Eimicke JP, Ramirez M, Silver S, Pillemer K. Verbal and physical aggression directed at nursing home staff by residents. J Gen Intern Med. 2013 May;28(5):660-7. doi: 10.1007/s11606-012-2284-1. Epub 2012 Dec 8.
PubMed 23225256Chappell NL, Novak M. Caring for institutionalized elders: Stress among nursing assistants. J Appl Gerontol. 1994;13(3):299-315.
Morgan DG, Stewart NJ, D'Arcy C, Forbes D, Lawson J. Work stress and physical assault of nursing aides in rural nursing homes with and without dementia special care units. J Psychiatr Ment Health Nurs. 2005 Jun;12(3):347-58. doi: 10.1111/j.1365-2850.2005.00846.x.
PubMed 15876243Schaefer JA, Moos RH. Effects of work stressors and work climate on long-term care staff's job morale and functioning. Res Nurs Health. 1996 Feb;19(1):63-73. doi: 10.1002/(SICI)1098-240X(199602)19:13.0.CO;2-J.
PubMed 8552804Cooper SL, Carleton HL, Chamberlain SA, Cummings GG, Bambrick W, Estabrooks CA. Burnout in the nursing home health care aide: A systematic review. Burn Res. 2016;3:76-87.
Astrom S, Nilsson M, Norberg A, Sandman PO, Winblad B. Staff burnout in dementia care--relations to empathy and attitudes. Int J Nurs Stud. 1991;28(1):65-75. doi: 10.1016/0020-7489(91)90051-4.
PubMed 1856035
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Self-Compassion Training to Improve Retention, Job Satisfaction, and Attitudes Toward Dementia Among Long-Term Care Nursing Assistants
- ClinicalTrials.gov ID
- NCT03720652
- Acronym / sponsor ID
- CNA / 18-2012
- Conditions
- Stress and Burnout
- Keywords
- Mindfulness, Certified Nursing Assistants, Long-Term Care, Staff Turnover, Mindful Self-Compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- Field test the feasibility and acceptability of our study recruitment and evaluation strategy.
- 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.
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 8-Week Mindful Self-Compassion (MSC) | Experimental | Behavioral: 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. |
| 6-Week Mindful Self Compassion (MSC) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| 8-Week Mindful Self-Compassion (MSC)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 | Behavioural | 8-Week Mindful Self-Compassion (MSC) |
| 6-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. | Behavioural | 6-Week Mindful Self Compassion (MSC) |
Primary outcome
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.
20 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19655659Jones AL, Dwyer LL, Bercovitz AR, Strahan GW. The National Nursing Home Survey: 2004 overview. Vital Health Stat 13. 2009 Jun;(167):1-155.
- BackgroundBarbarotta L. Direct Care Worker Retention: Strategies for Success.; 2010.
- Background: PubMed 24398653Castle NG, Ferguson-Rome JC. Influence of Nurse Aide Absenteeism on Nursing Home Quality. Gerontologist. 2015 Aug;55(4):605-15. doi: 10.1093/geront/gnt167. Epub 2014 Jan 7.
- Background: PubMed 17989407Castle NG, Engberg J, Men A. Nursing home staff turnover: impact on nursing home compare quality measures. Gerontologist. 2007 Oct;47(5):650-61. doi: 10.1093/geront/47.5.650.
- Background: PubMed 24139163Lerner NB, Johantgen M, Trinkoff AM, Storr CL, Han K. Are nursing home survey deficiencies higher in facilities with greater staff turnover. J Am Med Dir Assoc. 2014 Feb;15(2):102-7. doi: 10.1016/j.jamda.2013.09.003. Epub 2013 Oct 15.
- Background: PubMed 24232236Trinkoff AM, Han K, Storr CL, Lerner N, Johantgen M, Gartrell K. Turnover, staffing, skill mix, and resident outcomes in a national sample of US nursing homes. J Nurs Adm. 2013 Dec;43(12):630-6. doi: 10.1097/NNA.0000000000000004.
- Background: PubMed 20225727Cook G, Brown-Wilson C. Care home residents' experiences of social relationships with staff. Nurs Older People. 2010 Feb;22(1):24-9. doi: 10.7748/nop2010.02.22.1.24.c7492.
- Background: PubMed 19363014Squillace MR, Remsburg RE, Harris-Kojetin LD, Bercovitz A, Rosenoff E, Han B. The National Nursing Assistant Survey: improving the evidence base for policy initiatives to strengthen the certified nursing assistant workforce. Gerontologist. 2009 Apr;49(2):185-97. doi: 10.1093/geront/gnp024. Epub 2009 Apr 1.
- Background: PubMed 22875015Dill JS, Morgan JC, Marshall VW, Pruchno R. Contingency, employment intentions, and retention of vulnerable low-wage workers: an examination of nursing assistants in nursing homes. Gerontologist. 2013 Apr;53(2):222-34. doi: 10.1093/geront/gns085. Epub 2012 Aug 8.
- Background: PubMed 23225256Lachs MS, Rosen T, Teresi JA, Eimicke JP, Ramirez M, Silver S, Pillemer K. Verbal and physical aggression directed at nursing home staff by residents. J Gen Intern Med. 2013 May;28(5):660-7. doi: 10.1007/s11606-012-2284-1. Epub 2012 Dec 8.
- BackgroundChappell NL, Novak M. Caring for institutionalized elders: Stress among nursing assistants. J Appl Gerontol. 1994;13(3):299-315.
- Background: PubMed 15876243Morgan DG, Stewart NJ, D'Arcy C, Forbes D, Lawson J. Work stress and physical assault of nursing aides in rural nursing homes with and without dementia special care units. J Psychiatr Ment Health Nurs. 2005 Jun;12(3):347-58. doi: 10.1111/j.1365-2850.2005.00846.x.
- Nursing Home CompareLink provided by the sponsor.
- Unscheduled Absence Survey: CCH Survey Finds Unscheduled Absenteeism Up in U.S. Workplaces.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
Philip D Sloane, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-Week Mindful Self-Compassion (MSC) and 6-Week Mindful Self-Compassion (MSC) in people with Stress and Burnout, run by University of North Carolina, Chapel Hill 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 7 inclusion and 4 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 29 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). 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 NCT03720652, which also lists 73 linked publications.
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 29 Apr 2021.