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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03687450
Recruitment Status : Completed
First Posted : September 27, 2018
Results First Posted : July 23, 2020
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
Kripalu Center for Yoga and Health
Information provided by (Responsible Party):
Sat Bir Khalsa, PhD, Brigham and Women's Hospital

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.


Condition or disease Intervention/treatment Phase
Burnout, Professional Anxiety Depression Stress Behavioral: RISE yoga-based program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

Arm Intervention/treatment
Experimental: Intervention (Yoga) Arm
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
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.

No Intervention: No-treatment Control Arm
Waitlist control-- group received one session of yoga-based class at the completion of the study.



Primary Outcome Measures :
  1. Feasibility of Attending the Yoga Program [ Time Frame: Post-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.


Secondary Outcome Measures :
  1. Difference in Burnout [ Time Frame: Post-program and 2-month follow-up ]
    Maslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout

  2. Difference in Professional Fulfillment [ Time Frame: Baseline, post-program, and 2-month follow-up ]
    Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for professional fulfillment scale; higher is more fulfillment

  3. Difference in Resident Well-being [ Time Frame: Baseline, post-program, and 2-month follow-up ]
    Resident Well-Being Index (7 items) - scores from 0-7; higher is worse wellbeing

  4. Difference in Resilience [ Time Frame: Baseline, post-program, and 2-month follow-up ]
    Resilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience

  5. Difference in Mindfulness [ Time Frame: Baseline, post-program, and 2-month follow-up ]
    Five Facet Mindfulness Questionnaire (FFMQ; short form, 15 items) - scores from 15-75; higher score means more mindfulness

  6. Difference in Stress [ Time Frame: Baseline, post-program, and 2-month follow-up ]
    Perceived Stress Scale (PSS; 10 items) - scores from 0-40; higher is more stress

  7. Difference in Depression [ Time Frame: Baseline, post-program, and 2-month follow-up ]
    Patient Reported Outcomes Measurement Information System (PROMIS) Depression (short form: depression-4) - scores from 4-20, higher is more depression

  8. Difference in Sleep Quality [ Time Frame: Baseline, post-program, and 2-month follow-up ]
    PROMIS Sleep Disturbance (short form, 4 items) - scores from 4-20, higher is more sleep disturbance

  9. Difference in Anxiety [ Time Frame: Baseline, post-program, and 2-month follow-up ]
    Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (short form: anxiety-4) - scores from 4-20, higher is more anxiety

  10. Differences in Professional Fulfillment - Burnout Sub-Item [ Time Frame: Baseline, post-program, and 2-month follow-up ]
    Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for the burnout scale; higher is more burnout



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687450


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
Kripalu Center for Yoga and Health
Investigators
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Principal Investigator: Sat Bir Khalsa, PhD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Sat Bir Khalsa, PhD, Brigham and Women's Hospital:
Study Protocol  [PDF] May 4, 2019
No Statistical Analysis Plan (SAP) exists for this study.

Publications:

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Responsible Party: Sat Bir Khalsa, PhD, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03687450    
Other Study ID Numbers: 2017P002372
First Posted: September 27, 2018    Key Record Dates
Results First Posted: July 23, 2020
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sat Bir Khalsa, PhD, Brigham and Women's Hospital:
yoga
mindfulness
meditation
resident
residency
Additional relevant MeSH terms:
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Burnout, Professional
Behavioral Symptoms
Burnout, Psychological
Stress, Psychological
Occupational Stress
Occupational Diseases