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NCT03720652: CNA

Certified Nursing Assistants' Wellbeing

Completed NA Results posted Last updated 29 April 2021
What this trial tests

NA trial testing 8-Week Mindful Self-Compassion (MSC) in Stress and Burnout in 39 participants. Completed in 23 June 2020.

Timeline
27 March 2019
Primary endpoint
2 June 2020
23 June 2020

Quick facts

Lead sponsorUniversity of North Carolina, Chapel Hill
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment39
Start date27 March 2019
Primary completion2 June 2020
Estimated completion23 June 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, any sex, with Stress and Burnout. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)9
6-Week Mindful Self Compassion (MSC)13
8-Week Mindful Self-Compassion (MSC)1
6-Week Mindful Self Compassion (MSC)5
8-Week Mindful Self-Compassion (MSC)1
6-Week Mindful Self Compassion (MSC)3
End-of-Intervention Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)6
6-Week Mindful Self Compassion (MSC)9
8-Week Mindful Self-Compassion (MSC)2
6-Week Mindful Self Compassion (MSC)8
8-Week Mindful Self-Compassion (MSC)2
6-Week Mindful Self Compassion (MSC)3
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)6
6-Week Mindful Self Compassion (MSC)8
8-Week Mindful Self-Compassion (MSC)2
6-Week Mindful Self Compassion (MSC)7
8-Week Mindful Self-Compassion (MSC)1
6-Week Mindful Self Compassion (MSC)3
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)6
6-Week Mindful Self Compassion (MSC)6
8-Week Mindful Self-Compassion (MSC)0
6-Week Mindful Self Compassion (MSC)5
8-Week Mindful Self-Compassion (MSC)1
6-Week Mindful Self Compassion (MSC)5
Change in Mean Score Over Time on Job Satisfaction Scale (JSS) Secondary · 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.

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)15.00± 4.02
6-Week Mindful Self Compassion (MSC)14.71± 3.08
End-of-Intervention Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)15.80± 1.55
6-Week Mindful Self Compassion (MSC)14.40± 2.14
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)16.20± 2.70
6-Week Mindful Self Compassion (MSC)14.95± 1.87
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)14.00± 3.71
6-Week Mindful Self Compassion (MSC)15.69± 2.44
Change in Mean Score Over Time on Approach to Dementia Questionnaire (ADQ) - Recognition of Personhood Subscale Secondary · 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.

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)38.00± 3.95
6-Week Mindful Self Compassion (MSC)36.86± 3.73
End-of-Intervention Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)39.00± 5.25
6-Week Mindful Self Compassion (MSC)38.30± 3.26
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)38.70± 5.66
6-Week Mindful Self Compassion (MSC)37.21± 5.37
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)40.30± 3.83
6-Week Mindful Self Compassion (MSC)38.13± 4.86
Change in Mean Score Over Time on Perceived Stress Scale (PSS) Secondary · 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.

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)11.64± 4.99
6-Week Mindful Self Compassion (MSC)14.19± 7.33
End-of-Intervention Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)7.90± 4.38
6-Week Mindful Self Compassion (MSC)12.05± 5.64
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)9.10± 6.67
6-Week Mindful Self Compassion (MSC)11.53± 6.07
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)8.10± 5.61
6-Week Mindful Self Compassion (MSC)12.19± 7.09
Change in Mean Score Over Time on PROMIS Depression Scale Secondary · 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.

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)10.27± 2.80
6-Week Mindful Self Compassion (MSC)14.29± 6.17
End-of-Intervention Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)11.70± 4.27
6-Week Mindful Self Compassion (MSC)11.00± 3.51
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)11.30± 3.47
6-Week Mindful Self Compassion (MSC)11.79± 3.84
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)11.80± 4.21
6-Week Mindful Self Compassion (MSC)12.31± 3.28
Change in Mean Score Over Time on Maslach Burnout Inventory (MBI) - Depersonalization Subscale Secondary · 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-mont

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)0.42± 0.56
6-Week Mindful Self Compassion (MSC)0.85± 0.88
End-of-Intervention Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)0.28± 0.33
6-Week Mindful Self Compassion (MSC)0.59± 0.57
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)0.54± 0.65
6-Week Mindful Self Compassion (MSC)0.72± 0.75
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)0.30± 0.25
6-Week Mindful Self Compassion (MSC)0.61± 0.58
Change in Mean Score Over Time on Maslach Burnout Inventory (MBI) - Emotional Exhaustion Subscale Secondary · 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-m

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)1.69± 1.13
6-Week Mindful Self Compassion (MSC)2.05± 1.35
End-of-Intervention Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)1.08± 0.98
6-Week Mindful Self Compassion (MSC)1.84± 1.19
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)0.90± 0.77
6-Week Mindful Self Compassion (MSC)1.91± 1.42
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)0.93± 0.79
6-Week Mindful Self Compassion (MSC)1.58± 1.39
Change in Mean Score Over Time on Maslach Burnout Inventory (MBI) - Personal Accomplishment Subscale Secondary · 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

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)4.97± 0.58
6-Week Mindful Self Compassion (MSC)4.59± 1.22
End-of-Intervention Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)5.07± 0.86
6-Week Mindful Self Compassion (MSC)4.74± 0.95
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)4.99± 1.02
6-Week Mindful Self Compassion (MSC)4.35± 1.12
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)5.14± 0.92
6-Week Mindful Self Compassion (MSC)4.31± 1.25
Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) Secondary · 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.

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)3.72± 0.52
6-Week Mindful Self Compassion (MSC)2.73± 0.38
End-of-Intervention Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)3.64± 0.61
6-Week Mindful Self Compassion (MSC)3.77± 0.58
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)3.71± 0.50
6-Week Mindful Self Compassion (MSC)3.88± 0.62
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)3.68± 0.34
6-Week Mindful Self Compassion (MSC)3.85± 0.66
Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) - Self-kindness Subscale Secondary · 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.

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)4.00± 0.75
6-Week Mindful Self Compassion (MSC)3.22± 0.61
End-of-Intervention Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)3.50± 0.96
6-Week Mindful Self Compassion (MSC)3.75± 0.73
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)3.80± 1.12
6-Week Mindful Self Compassion (MSC)3.84± 0.61
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)3.87± 0.69
6-Week Mindful Self Compassion (MSC)3.90± 0.80
Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) - Self-judgment Subscale Secondary · 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.

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)2.39± 0.96
6-Week Mindful Self Compassion (MSC)3.33± 0.99
End-of-Intervention Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)2.43± 1.31
6-Week Mindful Self Compassion (MSC)2.25± 0.89
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)2.20± 0.80
6-Week Mindful Self Compassion (MSC)1.95± 0.86
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)2.13± 0.50
6-Week Mindful Self Compassion (MSC)2.08± 0.82
Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) - Common Humanity Subscale Secondary · 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.

Baseline
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)3.48± 0.85
6-Week Mindful Self Compassion (MSC)2.56± 0.99
End-of-Intervention
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)3.83± 0.76
6-Week Mindful Self Compassion (MSC)3.67± 0.84
3-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)3.37± 1.21
6-Week Mindful Self Compassion (MSC)3.68± 0.86
6-Month Follow Up Interview
GroupValue95% CI
8-Week Mindful Self-Compassion (MSC)3.03± 0.67
6-Week Mindful Self Compassion (MSC)3.63± 1.13

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected over the course of the intervention and follow-up interviews. This total time period was 8 months per participant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

8-Week Mindful Self-Compassion (MSC)
Serious: 0/11 (0%)
Deaths: 0/11
6-Week Mindful Self Compassion (MSC)
Serious: 1/21 (5%)
Deaths: 0/21

Serious adverse events (1 terms)

ReactionSystem8-Week Mindful Self-Compas…6-Week Mindful Self Compas…
Vehicular AccidentSurgical and medical procedures——
Other adverse events (1 terms — click to expand)

ReactionSystem8-Week Mindful Self-Compas…6-Week Mindful Self Compas…
Pulled MuscleInfections and infestations——

Most-reported serious reactions: Vehicular Accident.

Data from ClinicalTrials.gov NCT03720652 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Certified nursing assistants' experiences with self-compassion training in the nursing home setting.
    Lathren C, Sheffield-Abdullah K, Sloane PD, Bluth K, et al · · 2021 · cited 12× · PMID 34560529 · DOI 10.1016/j.gerinurse.2021.08.013

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