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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687450
• Other study ID #: 2017P002372
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anxiety
• Burnout, Professional
• Depression
• Stress

Intervention

Behavioral:
• RISE yoga-based program
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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Kripalu Center for Yoga and Health

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in Burnout	Maslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout	Post-program and 2-month follow-up
Secondary	Difference in Professional Fulfillment	Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for professional fulfillment scale; higher is more fulfillment	Baseline, post-program, and 2-month follow-up
Secondary	Difference in Resident Well-being	Resident Well-Being Index (7 items) - scores from 0-7; higher is worse wellbeing	Baseline, post-program, and 2-month follow-up
Secondary	Difference in Resilience	Resilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience	Baseline, post-program, and 2-month follow-up
Secondary	Difference in Mindfulness	Five Facet Mindfulness Questionnaire (FFMQ; short form, 15 items) - scores from 15-75; higher score means more mindfulness	Baseline, post-program, and 2-month follow-up
Secondary	Difference in Stress	Perceived Stress Scale (PSS; 10 items) - scores from 0-40; higher is more stress	Baseline, post-program, and 2-month follow-up
Secondary	Difference in Depression	Patient Reported Outcomes Measurement Information System (PROMIS) Depression (short form: depression-4) - scores from 4-20, higher is more depression	Baseline, post-program, and 2-month follow-up
Secondary	Difference in Sleep Quality	PROMIS Sleep Disturbance (short form, 4 items) - scores from 4-20, higher is more sleep disturbance	Baseline, post-program, and 2-month follow-up
Secondary	Difference in Anxiety	Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (short form: anxiety-4) - scores from 4-20, higher is more anxiety	Baseline, post-program, and 2-month follow-up
Secondary	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	Baseline, post-program, and 2-month follow-up