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Burnout, ProfessionalNCT03687450

Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians

A study testing RISE yoga-based program in people with Burnout, Professional and Anxiety, run by Brigham and Women's Hospital 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 investigators aim to initiate and complete the first investigation of the effect of a yoga-based program on resident physicians' psychological health using a randomized controlled trial to assess feasibility of the program in this population and measure outcomes across several domains. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Burnout, Professional, Anxiety, Depression
What is being tested?
RISE yoga-based program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
1 Nov 2018to 1 May 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

  • Individuals enrolled in residency programs at Brigham and Women's Hospital, Beth Israel Deaconess, Boston Children's Hospital, or a Harvard Combined Residency Program
  • Individuals must be willing to not practice mind-body programs other than the intervention during the treatment protocol
  • Must be proficient in English

Who cannot join

  • Individuals who currently practice yoga, meditation, tai chi, qigong, and other mind-body practices more than 25 hours in the past 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

Other trials in United States

About this study

The investigators aim to initiate and complete the first investigation of the effect of a yoga-based program on resident physicians' psychological health using a randomized controlled trial to assess feasibility of the program in this population and measure outcomes across several domains. To meet the goals of the proposed project the investigators have identified 3 specific aims:

Specific Aim 1: Assess the acceptability and feasibility of the yoga program through measuring participation and conducting standardized interviews with a subset of yoga participants.

Read more

Specific Aim 2: Evaluate the effect of the yoga program on resident physicians' stress, burnout, resilience, mindfulness, mood, depression, anxiety, and sleep quality using quantitative self-report measures.

Specific Aim 3. Examine whether outcome measures were perceived as relevant to the participants' work environment and were not burdensome as to the length and content of the program.

Read the detailed description

The project will implement a single group mixed-methods randomized controlled trial to investigate the impact of the 6-week RISE program on psychological health in Longwood medical area residents. The RISE program is an existing standardized yoga program at Kripalu that will be adapted for residents in a 60-90-minute, once-weekly class for six weeks. Participants will be randomized to either the RISE yoga program or a no-treatment control group. Participants randomized to the RISE program will also be instructed to maintain a short 10-15-minute daily home yoga practice. Sessions will be lead by experienced instructors from Kripalu and will be held in the Longwood medical area. Self-report outcomes will be assessed at baseline, at program completion (post-program), at 2-month follow-up, and at 6-month follow-up.

Participants will include resident physicians at Longwood medical area hospitals. The only exclusion criterion is having practiced yoga, meditation, tai chi, qigong, or another mind-body practice at least 25 hours or more in the past 6 months. Participants must be willing not to practice mind-body programs other than the treatment protocol during the intervention. We plan to enroll up to 200 participants with a goal of at least 60 participants with a 2:1 ratio of participants randomized to yoga to participants randomized to control. The control group will receive one session of RISE after their participation in the trial is complete.

Being tested
RISE yoga-based program
Keywords
yoga, mindfulness, meditation, resident, residency
Medical subject headings
Burnout, Professional, Anxiety Disorders, Depression

What participants receive

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

  • RISE yoga-based programBehavioural

    The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.

Study groups in NCT03687450
Study groupRoleWhat they receive
Intervention (Yoga) ArmExperimentalReceived a weekly 60-minute yoga-based class over 6 weeks with direction for a 5-10 minute daily home practice.
Receives: Behavioral: RISE yoga-based program
No-treatment Control ArmNo interventionWaitlist control-- group received one session of yoga-based class at the completion of the study.

What is being measured

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

  1. Feasibility of Attending the Yoga Program

    Participants were ask to rate the feasibility of attending the yoga program on a visual analogue scale from 0 (not at all feasible) to 100 (very feasible). Only the intervention group rated feasibility since the control group was a waitlist control group and did not attend the program. The standard deviation of the mean score was calculated.

    Measured: Post-program

Secondary outcomes (10)

  1. Difference in Burnout

    Maslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout

    Measured: Post-program and 2-month follow-up

  2. Difference in Professional Fulfillment

    Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for professional fulfillment scale; higher is more fulfillment

    Measured: Baseline, post-program, and 2-month follow-up

  3. Difference in Resident Well-being

    Resident Well-Being Index (7 items) - scores from 0-7; higher is worse wellbeing

    Measured: Baseline, post-program, and 2-month follow-up

  4. Difference in Resilience

    Resilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience

    Measured: Baseline, post-program, and 2-month follow-up

  5. Difference in Mindfulness

    Five Facet Mindfulness Questionnaire (FFMQ; short form, 15 items) - scores from 15-75; higher score means more mindfulness

    Measured: Baseline, post-program, and 2-month follow-up

  6. Difference in Stress

    Perceived Stress Scale (PSS; 10 items) - scores from 0-40; higher is more stress

    Measured: Baseline, post-program, and 2-month follow-up

  7. Difference in Depression

    Patient Reported Outcomes Measurement Information System (PROMIS) Depression (short form: depression-4) - scores from 4-20, higher is more depression

    Measured: Baseline, post-program, and 2-month follow-up

  8. Difference in Sleep Quality

    PROMIS Sleep Disturbance (short form, 4 items) - scores from 4-20, higher is more sleep disturbance

    Measured: Baseline, post-program, and 2-month follow-up

  9. Difference in Anxiety

    Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (short form: anxiety-4) - scores from 4-20, higher is more anxiety

    Measured: Baseline, post-program, and 2-month follow-up

  10. Differences in Professional Fulfillment - Burnout Sub-Item

    Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for the burnout scale; higher is more burnout

    Measured: Baseline, post-program, and 2-month follow-up

Timeline

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

  1. First posted27 Sep 2018
  2. Study start1 Nov 2018
  3. Primary completion1 May 2020
  4. Study completion1 May 2020

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03687450
Sponsor's protocol ID
2017P002372
Status last verified
Jul 2020
First submitted
27 Mar 2018
Last updated
23 Jul 2020
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78.

    PubMed 7850498

  • Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

    PubMed 16443717

  • Baer RA, Carmody J, Hunsinger M. Weekly change in mindfulness and perceived stress in a mindfulness-based stress reduction program. J Clin Psychol. 2012 Jul;68(7):755-65. doi: 10.1002/jclp.21865. Epub 2012 May 23.

    PubMed 22623334

  • Gu J, Strauss C, Crane C, Barnhofer T, Karl A, Cavanagh K, Kuyken W. Examining the factor structure of the 39-item and 15-item versions of the Five Facet Mindfulness Questionnaire before and after mindfulness-based cognitive therapy for people with recurrent depression. Psychol Assess. 2016 Jul;28(7):791-802. doi: 10.1037/pas0000263. Epub 2016 Apr 14.

    PubMed 27078186

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PubMed 6668417

  • West CP, Dyrbye LN, Sloan JA, Shanafelt TD. Single item measures of emotional exhaustion and depersonalization are useful for assessing burnout in medical professionals. J Gen Intern Med. 2009 Dec;24(12):1318-21. doi: 10.1007/s11606-009-1129-z. Epub 2009 Oct 3.

    PubMed 19802645

  • West CP, Dyrbye LN, Satele DV, Sloan JA, Shanafelt TD. Concurrent validity of single-item measures of emotional exhaustion and depersonalization in burnout assessment. J Gen Intern Med. 2012 Nov;27(11):1445-52. doi: 10.1007/s11606-012-2015-7. Epub 2012 Feb 24.

    PubMed 22362127

  • 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

  • Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.

    PubMed 16004657

  • Pilkonis PA, Yu L, Dodds NE, Johnston KL, Maihoefer CC, Lawrence SM. Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study. J Psychiatr Res. 2014 Sep;56:112-9. doi: 10.1016/j.jpsychires.2014.05.010. Epub 2014 May 29.

    PubMed 24931848

  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PubMed 3397865

  • Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.

    PubMed 22250775

  • Dyrbye LN, Satele D, Sloan J, Shanafelt TD. Ability of the physician well-being index to identify residents in distress. J Grad Med Educ. 2014 Mar;6(1):78-84. doi: 10.4300/JGME-D-13-00117.1.

    PubMed 24701315

Questions about this trial

What is this clinical trial studying?

A study testing RISE yoga-based program in people with Burnout, Professional and Anxiety, run by Brigham and Women's Hospital 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 1 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 23 Jul 2020. 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 23 Jul 2020). 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?

Feasibility of Attending the Yoga Program (time frame: Post-program). 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 NCT03687450, which also lists 13 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 23 Jul 2020.

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