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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burnout, Professional, Anxiety, Depression, Stress

Intervention / Treatment
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* Behavioral: RISE yoga-based program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Yoga) Arm<br>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<br>* 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.<br>|
| No Intervention: No-treatment Control Arm<br>Waitlist control-- group received one session of yoga-based class at the completion of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Difference in Resilience | Resilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience | Baseline, post-program, and 2-month follow-up | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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yoga, mindfulness, meditation, resident, residency