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Certified Nursing Assistants' Wellbeing (CNA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03720652
Recruitment Status : Completed
First Posted : October 25, 2018
Results First Posted : April 29, 2021
Last Update Posted : April 29, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Stress and Burnout Behavioral: 8-Week Mindful Self-Compassion (MSC) Behavioral: 6-Week Mindful Self-Compassion (MSC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Mindful Self-Compassion Training to Improve Retention, Job Satisfaction, and Attitudes Toward Dementia Among Long-Term Care Nursing Assistants
Actual Study Start Date : March 27, 2019
Actual Primary Completion Date : June 2, 2020
Actual Study Completion Date : June 23, 2020

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.
Behavioral: 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

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.
Behavioral: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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).

  17. 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.

  18. 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.

  19. 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.

  20. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720652


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Philip D Sloane, MD, MPH University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
Study Protocol  [PDF] March 18, 2021
Statistical Analysis Plan  [PDF] March 8, 2021

Additional Information:
Publications:
Barbarotta L. Direct Care Worker Retention: Strategies for Success.; 2010.
Chappell NL, Novak M. Caring for institutionalized elders: Stress among nursing assistants. J Appl Gerontol. 1994;13(3):299-315.
Cooper 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.
Kabat-Zinn J. Wherever You Go, There You Are: Mindfulness in Everyday Life. New York: Hyperion; 1994.
Egan H, Mantzios M, Jackson C. Health Practitioners and the Directive Towards Compassionate Healthcare in the UK: Exploring the Need to Educate Health Practitioners on How to be Self-Compassionate and Mindful Alongside Mandating Compassion Towards Patients. Heal Prof Educ. 2016:9-11.
Neff KD, Dahm KA. Self-Compassion: What It Is, What It Does, and How It Relates to Mindfulness. (Robinson M, Meier B, Ostafin B, eds.). New York: Springer; 2015.
Gerber Z, Tolmacz R, Doron Y. Self-compassion and forms of concern for others. Pers Individ Dif. 2015;86:394-400.
Cohen S, Williamson G. The social psychology of health: Claremont symposium on applied social psychology. In: Perceived Stress in a Probability Sample of the United States. In: Spacapan S, Oskamp S, Eds. Newbury Park, CA: Sage; 1988.
Roberti J, Harrington L, Storch E. Further psychometric support for the 10- item version of the perceived stress scale. J Coll Couns. 2006;9(2):135-147.
Lintern T, Woods B, Phair L. Training is not enough to change care practice. J Dement Care. 2000;8:15-17.
Lintern T. Quality in Dementia Care: Evaluating Staff Attitudes and Behaviour. 2001.
Maslach C, Jackson S, Leiter M. Maslach Burnout Inventory. Palo Alto; 1986.
Diener E, Inglehart R, Tay L. Theory and validity of life satisfaction scales. Soc Indic Res. 2013;112(3):497-527.
Cammann C, Fichman M, Jenkins D, Klesh J. Assessing the attitudes and perceptions of organizational members. In: Assessing Organizational Change: A Guide to Methods, Measures, and Practices. Vol 71.; 1983.
McFarlin D, Rice R. The role of facet importance as a moderator in job satisfaction processes. J Organ Behav. 1992;13(1):41-54.
Pearson C. An assessment of extrinsic feedback on participation, role perceptions, motivation, and job satisfaction in a self-managed system for monitoring group achievement. Hum relations.1991;44(5):517-537.
Sanchez J, Brock P. Sanchez JI, Brock P. Outcomes of perceived discrimination among Hispanic employees: is diversity management a luxury or a necessity? Academy of Management Journal. 1996;39(3):704-719. Acad Manag Journal. 1996;39(3):704-719.
Siegall M, McDonald T. Focus of Attention and Employee Reactions to Job Change. J Appl Soc Psychol. 1995;25(13):1121-1141.
Sanchez J, Kraus E, White S, Williams M. Adopting high-involvement human resource practices the mediating role of benchmarking. Gr Organ Manag. 1999;24(4):461-478.
George J. Leader positive mood and group performance: The case of customer service. J Appl Soc Psychol. 1995;25(9):778-794.
Fletcher S, Zimmerman S, Preisser JS, Mitchell C, Reed D, Gould E, Beeber A, Reed P. Implementation fidelity of a standardized Dementia Care training program across multiple trainers and settings. Alzheimers care today. 2010;11(1):51-60.

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03720652    
Other Study ID Numbers: 18-2012
1R21AG058133-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2018    Key Record Dates
Results First Posted: April 29, 2021
Last Update Posted: April 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Mindfulness
Certified Nursing Assistants
Long-Term Care
Staff Turnover
Mindful Self-Compassion
Additional relevant MeSH terms:
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Burnout, Psychological
Stress, Psychological
Behavioral Symptoms