NCT03687450

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

July 23, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

March 27, 2018

Results QC Date

June 10, 2020

Last Update Submit

July 8, 2020

Conditions

Burnout, ProfessionalAnxietyDepressionStress

Keywords

yogamindfulnessmeditationresidentresidency

Outcome Measures

Primary Outcomes (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.

    Post-program

Secondary Outcomes (10)

  • Difference in Burnout

    Post-program and 2-month follow-up

  • Difference in Professional Fulfillment

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

  • Difference in Resident Well-being

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

  • Difference in Resilience

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

  • Difference in Mindfulness

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

  • +5 more secondary outcomes

Study Arms (2)

Intervention (Yoga) Arm

EXPERIMENTAL

Received a weekly 60-minute yoga-based class over 6 weeks with direction for a 5-10 minute daily home practice.

Behavioral: RISE yoga-based program

No-treatment Control Arm

NO INTERVENTION

Waitlist control-- group received one session of yoga-based class at the completion of the study.

Interventions

RISE yoga-based programBEHAVIORAL

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.

Intervention (Yoga) Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (13)

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

    PMID: 7850498BACKGROUND

  • 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.

    PMID: 16443717BACKGROUND

  • 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.

    PMID: 22623334BACKGROUND

  • 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.

    PMID: 27078186BACKGROUND

  • 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.

    PMID: 6668417BACKGROUND

  • 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.

    PMID: 19802645BACKGROUND

  • 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.

    PMID: 22362127BACKGROUND

  • 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.

    PMID: 29196982BACKGROUND

  • 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.

    PMID: 16004657BACKGROUND

  • 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.

    PMID: 24931848BACKGROUND

  • 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.

    PMID: 3397865BACKGROUND

  • 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.

    PMID: 22250775BACKGROUND

  • 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.

    PMID: 24701315BACKGROUND

MeSH Terms

Conditions

Burnout, ProfessionalAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Results Point of Contact

Title
Julia Loewenthal, MD
Organization
Brigham and Women's Hospital
jloewenthal@bwh.harvard.edu
6177325500

Study Officials

  • Sat Bir Khalsa, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

March 27, 2018

First Posted

September 27, 2018

Study Start

November 1, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

July 23, 2020

Results First Posted

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)