Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians
Primary Purpose
Burnout, Professional, Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RISE yoga-based program
Sponsored by
About this trial
This is an interventional treatment trial for Burnout, Professional focused on measuring yoga, mindfulness, meditation, resident, residency
Eligibility 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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention (Yoga) Arm
No-treatment Control Arm
Arm Description
Received a weekly 60-minute yoga-based class over 6 weeks with direction for a 5-10 minute daily home practice.
Waitlist control-- group received one session of yoga-based class at the completion of the study.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Difference in Burnout
Maslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout
Difference in Professional Fulfillment
Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for professional fulfillment scale; higher is more fulfillment
Difference in Resident Well-being
Resident Well-Being Index (7 items) - scores from 0-7; higher is worse wellbeing
Difference in Resilience
Resilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience
Difference in Mindfulness
Five Facet Mindfulness Questionnaire (FFMQ; short form, 15 items) - scores from 15-75; higher score means more mindfulness
Difference in Stress
Perceived Stress Scale (PSS; 10 items) - scores from 0-40; higher is more stress
Difference in Depression
Patient Reported Outcomes Measurement Information System (PROMIS) Depression (short form: depression-4) - scores from 4-20, higher is more depression
Difference in Sleep Quality
PROMIS Sleep Disturbance (short form, 4 items) - scores from 4-20, higher is more sleep disturbance
Difference in Anxiety
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (short form: anxiety-4) - scores from 4-20, higher is more anxiety
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
Full Information
NCT ID
NCT03687450
First Posted
March 27, 2018
Last Updated
July 8, 2020
Sponsor
Brigham and Women's Hospital
Collaborators
Kripalu Center for Yoga and Health
1. Study Identification
Unique Protocol Identification Number
NCT03687450
Brief Title
Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians
Official Title
Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Kripalu Center for Yoga and Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional, Anxiety, Depression, Stress
Keywords
yoga, mindfulness, meditation, resident, residency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention (Yoga) Arm
Arm Type
Experimental
Arm Description
Received a weekly 60-minute yoga-based class over 6 weeks with direction for a 5-10 minute daily home practice.
Arm Title
No-treatment Control Arm
Arm Type
No Intervention
Arm Description
Waitlist control-- group received one session of yoga-based class at the completion of the study.
Intervention Type
Behavioral
Intervention Name(s)
RISE yoga-based program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Attending the Yoga Program
Description
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.
Time Frame
Post-program
Secondary Outcome Measure Information:
Title
Difference in Burnout
Description
Maslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout
Time Frame
Post-program and 2-month follow-up
Title
Difference in Professional Fulfillment
Description
Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for professional fulfillment scale; higher is more fulfillment
Time Frame
Baseline, post-program, and 2-month follow-up
Title
Difference in Resident Well-being
Description
Resident Well-Being Index (7 items) - scores from 0-7; higher is worse wellbeing
Time Frame
Baseline, post-program, and 2-month follow-up
Title
Difference in Resilience
Description
Resilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience
Time Frame
Baseline, post-program, and 2-month follow-up
Title
Difference in Mindfulness
Description
Five Facet Mindfulness Questionnaire (FFMQ; short form, 15 items) - scores from 15-75; higher score means more mindfulness
Time Frame
Baseline, post-program, and 2-month follow-up
Title
Difference in Stress
Description
Perceived Stress Scale (PSS; 10 items) - scores from 0-40; higher is more stress
Time Frame
Baseline, post-program, and 2-month follow-up
Title
Difference in Depression
Description
Patient Reported Outcomes Measurement Information System (PROMIS) Depression (short form: depression-4) - scores from 4-20, higher is more depression
Time Frame
Baseline, post-program, and 2-month follow-up
Title
Difference in Sleep Quality
Description
PROMIS Sleep Disturbance (short form, 4 items) - scores from 4-20, higher is more sleep disturbance
Time Frame
Baseline, post-program, and 2-month follow-up
Title
Difference in Anxiety
Description
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (short form: anxiety-4) - scores from 4-20, higher is more anxiety
Time Frame
Baseline, post-program, and 2-month follow-up
Title
Differences in Professional Fulfillment - Burnout Sub-Item
Description
Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for the burnout scale; higher is more burnout
Time Frame
Baseline, post-program, and 2-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sat Bir Khalsa, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians
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