AzTrials
AzTrials

Anxiety DepressionNCT04307563

Effects of Mindfulness Training on Burnout and Mood in Hospital Employees

A study testing Mindfulness session in people with Anxiety Depression and Burnout, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aims of the study are to 1) provide a hospital employee population with a mindfulness based stress reduction workshop and 2) evaluate the impact of this clinically validated group mindfulness intervention on burnout in health care employees. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety Depression, Burnout
What is being tested?
Mindfulness session
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
1 Sep 2021to 5 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

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

  • English speaking
  • Employees of Stanford Health Care
  • Ability to attend a minimum of 4 out of 6 sessions

Who cannot join

  • Non-English speaking
  • Employees with severe medical or psychiatric conditions that prevent them from participating in the group format

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford Health Care

    Palo Alto, California, 94305

Other trials in United States

About this study

Official title: Behavioral Health Support for Health Care Providers During COVID 19: A Remote Mindfulness Intervention

The primary aims of the study are to 1) provide a hospital employee population with a mindfulness based stress reduction workshop and 2) evaluate the impact of this clinically validated group mindfulness intervention on burnout in health care employees. Secondary outcomes will be anxiety, depression, quality of life and self compassion.

Being tested
Mindfulness session
Keywords
self-compassion, meditation, health personnel
Medical subject headings
Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness sessionBehavioural

    1.5 hour weekly session with health educator

Study groups in NCT04307563
Study groupRoleWhat they receive
Mindfulness groupOtherParticipants will attend 6 weekly educational and mindfulness sessions.
Receives: Behavioral: Mindfulness session

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Burnout

    1. Differences in Burnout scale between time points

    The Burnout Scale has been validated by Trockel et al. (2018).It is composed of two subscales (emotional exhaustion containing 4 questions and interpersonal disengagement containing 6 questions.) Both scales are scored on a Likert scale of 0 to 4 ("not at all" to "extremely"). For total Burnout score, the scores of the combined scale (10 total) are averaged. The higher scores indicate higher levels of overall burnout. Individual subscale means will also be computed (with higher scores indicating higher amounts of emotional exhaustion and interpersonal disengagement. Difference in overall burnout measured at four time points (week 1 and 6 of the intervention and 3 \& 6 months post intervention) will be reported and compared. The composite scales take approximately 2 minutes to complete.

    Measured: Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

Secondary outcomes (4)

  1. Change in Anxiety

    1. Differences in GAD-7 between time points.

    The Generalized Anxiety Disorder-7 is a well validated seven-item self-administered questionnaire used to measure anxiety. It has 7 questions with Likert scores ranging from "not at all" (score 0), "several days" (score 1), "more than half the days" (score 2), and "nearly every day (score 3). Scores range from 0 to 21 with higher scores indicating higher levels of anxiety, and a cutoff of or above 10 representing high likelihood of generalized anxiety disorder. Differences in GAD-7 measured at four time points (week 1 and 6 of the intervention and 3 \& 6 months post intervention) will be reported and compared. The scale takes approximately 2 minutes.

    Measured: Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

  2. Change in Depression

    1. Differences in CES-D between time points.

    The Center for Epidemiological Studies - Depression scale is a well validated self-administered questionnaire used to measure depression. The 20 item scale has Likert scores ranging from "rarely or none of the time" (score 0), "some or little of the time" (score 1), "moderate or much of the time" (score 2), and "most or almost all the time" (score 3). Scores range from 0 to 60 with higher scores indicated greater depressive symptoms. A cut off at or above 20 has sensitivity 79% and specificity of 80% for major depression. Difference in CES-D in 2019 measured at four time points (week 1 and 6 of the intervention and 3 \& 6 month post intervention) will be reported and compared. The scale takes approximately 5 minutes to complete.

    Measured: Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

  3. Change in Perceived Health

    1. Differences in GSRH between time points.

    A single item of the Health Related Quality of Life - 4 questionnaire "In general, would you say your health is Excellent (score 1), Very Good (score 2), Good (score 3), Fair (score 4), or Poor (score 5), the general self-rated health (GSRH), is a strong predictor of future health care utilization and mortality. It also has excellent validity. Higher scores of the GSRH are related to higher health care expenditures. Difference in GSRH measured at four time points (week 1 and 6 of the intervention and 3 \& 6 month post intervention) will be reported and compared. The scale takes less than 1 minute to complete.

    Measured: Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)

  4. Change in compassion

    1. Differences in compassion scores between time points.

    The 12 item Self-Compassion Scale - Short Form is strongly validated scale to measure self-compassion or "the ability to hold one's feelings of suffering with a sense of warmth, connection and concern". Higher levels of self-compassion are associated with less depression and anxiety. Five-point Likert score are from 1 ("Almost Never") to 5 ("Almost Always"). Total score is computed by reverse scoring negative items of self-judgement, isolation and over-identification (ie 1=5, 2=4, 3=3, 4=2, 5=1) and computing total mean. Difference in Compassion measured at four time points (week 1 and 6 of the intervention, and 3 \& 6 month post intervention) will be reported and compared. The scale takes approximately 5-10 minutes to complete.

    Measured: Four time points (week 1 and 6 of intervention, and 3 & 6 months post intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2020
  2. Study start1 Sep 2021
  3. Primary completion5 Jul 2022
  4. Study completion5 Jul 2022

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04307563
Sponsor's protocol ID
IRB-54792
Status last verified
Dec 2022
First submitted
11 Mar 2020
Last updated
12 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bazarko D, Cate RA, Azocar F, Kreitzer MJ. The Impact of an Innovative Mindfulness-Based Stress Reduction Program on the Health and Well-Being of Nurses Employed in a Corporate Setting. J Workplace Behav Health. 2013 Apr;28(2):107-133. doi: 10.1080/15555240.2013.779518.

    PubMed 23667348

  • Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA. 2002 Oct 23-30;288(16):1987-93. doi: 10.1001/jama.288.16.1987.

    PubMed 12387650

  • Vollestad J, Nielsen MB, Nielsen GH. Mindfulness- and acceptance-based interventions for anxiety disorders: a systematic review and meta-analysis. Br J Clin Psychol. 2012 Sep;51(3):239-60. doi: 10.1111/j.2044-8260.2011.02024.x. Epub 2011 Sep 9.

    PubMed 22803933

  • Hoge EA, Bui E, Marques L, Metcalf CA, Morris LK, Robinaugh DJ, Worthington JJ, Pollack MH, Simon NM. Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J Clin Psychiatry. 2013 Aug;74(8):786-92. doi: 10.4088/JCP.12m08083.

    PubMed 23541163

  • DeSalvo KB, Jones TM, Peabody J, McDonald J, Fihn S, Fan V, He J, Muntner P. Health care expenditure prediction with a single item, self-rated health measure. Med Care. 2009 Apr;47(4):440-7. doi: 10.1097/MLR.0b013e318190b716.

    PubMed 19238099

  • Zich JM, Attkisson CC, Greenfield TK. Screening for depression in primary care clinics: the CES-D and the BDI. Int J Psychiatry Med. 1990;20(3):259-77. doi: 10.2190/LYKR-7VHP-YJEM-MKM2.

    PubMed 2265888

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

  • Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

    PubMed 21584907

  • Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.

    PubMed 29196982

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness session in people with Anxiety Depression and Burnout, run by Stanford University 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 3 inclusion and 2 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 12 Dec 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Burnout (time frame: Four time points (week 1 and 6 of intervention, and 3 & 6 month post intervention)). 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 NCT04307563, which also lists 9 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 12 Dec 2022.

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