Anxiety, Burnout, Professional, Depression, Stress
Conditions
Keywords
yoga, mindfulness, meditation, resident, residency
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.
Interventions
BEHAVIORALRISE 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.
Sponsors
Kripalu Center for Yoga and Health
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Attending the Yoga Program | 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
| Measure | Time frame | Description |
|---|---|---|
| Difference in Stress | Baseline, post-program, and 2-month follow-up | Perceived Stress Scale (PSS; 10 items) - scores from 0-40; higher is more stress |
| Difference in Depression | 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 |
| Difference in Professional Fulfillment | 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 |
| Difference in Resident Well-being | Baseline, post-program, and 2-month follow-up | Resident Well-Being Index (7 items) - scores from 0-7; higher is worse wellbeing |
| Difference in Burnout | Post-program and 2-month follow-up | Maslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout |
| Difference in Mindfulness | 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 |
| Difference in Sleep Quality | Baseline, post-program, and 2-month follow-up | PROMIS Sleep Disturbance (short form, 4 items) - scores from 4-20, higher is more sleep disturbance |
| Difference in Anxiety | 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 |
| Differences in Professional Fulfillment - Burnout Sub-Item | 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 |
| Difference in Resilience | Baseline, post-program, and 2-month follow-up | Resilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention (Yoga) Arm This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
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. | 28 |
| No-treatment Control Arm This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class. | 16 |
| Total | 44 |
Baseline characteristics
| Characteristic | Intervention (Yoga) Arm | Total | No-treatment Control Arm |
|---|---|---|---|
| Age, Continuous | 29.3 years | 29.2 years | 29.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 40 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 28 Participants | 10 Participants |
| Sex: Female, Male Female | 21 Participants | 36 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 1 Participants |
| Specialty Anesthesiology | 3 Participants | 4 Participants | 1 Participants |
| Specialty Diagnostic Radiology | 3 Participants | 5 Participants | 2 Participants |
| Specialty Emergency Medicine | 2 Participants | 2 Participants | 0 Participants |
| Specialty Internal Medicine | 12 Participants | 20 Participants | 8 Participants |
| Specialty Medicine-Pediatrics | 1 Participants | 1 Participants | 0 Participants |
| Specialty OB/GYN | 3 Participants | 5 Participants | 2 Participants |
| Specialty Physical Medicine & Rehabilitation | 0 Participants | 1 Participants | 1 Participants |
| Specialty Psychiatry | 4 Participants | 6 Participants | 2 Participants |
| Year in Training 1st year | 9 Participants | 12 Participants | 3 Participants |
| Year in Training 2nd year | 6 Participants | 11 Participants | 5 Participants |
| Year in Training 3rd year | 8 Participants | 11 Participants | 3 Participants |
| Year in Training 4th year and above | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 18 |
| other Total, other adverse events | 0 / 38 | 0 / 18 |
| serious Total, serious adverse events | 0 / 38 | 0 / 18 |
Outcome results
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.
Time frame: Post-program
Population: Participants analyzed included those in the intervention group who completed any follow-up timepoint, including post-program and/or two-month follow-up. Since the waitlist control group did not attend the program, they were not asked to assess feasibility.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (Yoga) Arm | Feasibility of Attending the Yoga Program | 28.9 visual analogue scale, 0 to 100 | Standard Deviation 25.6 |
Secondary
Difference in Anxiety
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Yoga) Arm | Difference in Anxiety | Baseline | 9.65 score on a scale | Standard Error 0.6 |
| Intervention (Yoga) Arm | Difference in Anxiety | Post-program | 8.54 score on a scale | Standard Error 0.59 |
| Intervention (Yoga) Arm | Difference in Anxiety | 2-month follow-up | 8.96 score on a scale | Standard Error 0.57 |
| No-treatment Control Arm | Difference in Anxiety | Baseline | 10.00 score on a scale | Standard Error 1 |
| No-treatment Control Arm | Difference in Anxiety | Post-program | 9.15 score on a scale | Standard Error 0.94 |
| No-treatment Control Arm | Difference in Anxiety | 2-month follow-up | 7.94 score on a scale | Standard Error 0.81 |
Secondary
Difference in Burnout
Maslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout
Time frame: Post-program and 2-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Yoga) Arm | Difference in Burnout | Baseline | 6.23 score on a scale | Standard Error 0.52 |
| Intervention (Yoga) Arm | Difference in Burnout | Post-program | 5.65 score on a scale | Standard Error 0.5 |
| Intervention (Yoga) Arm | Difference in Burnout | 2-month follow-up | 5.72 score on a scale | Standard Error 0.53 |
| No-treatment Control Arm | Difference in Burnout | Baseline | 6.33 score on a scale | Standard Error 0.92 |
| No-treatment Control Arm | Difference in Burnout | Post-program | 6.83 score on a scale | Standard Error 0.66 |
| No-treatment Control Arm | Difference in Burnout | 2-month follow-up | 6.43 score on a scale | Standard Error 0.99 |
Secondary
Difference in Depression
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Yoga) Arm | Difference in Depression | Baseline | 7.56 score on a scale | Standard Error 0.64 |
| Intervention (Yoga) Arm | Difference in Depression | Post-program | 6.48 score on a scale | Standard Error 0.54 |
| Intervention (Yoga) Arm | Difference in Depression | 2-month follow-up | 7.24 score on a scale | Standard Error 0.61 |
| No-treatment Control Arm | Difference in Depression | Baseline | 7.15 score on a scale | Standard Error 1.13 |
| No-treatment Control Arm | Difference in Depression | Post-program | 7.23 score on a scale | Standard Error 0.75 |
| No-treatment Control Arm | Difference in Depression | 2-month follow-up | 7.81 score on a scale | Standard Error 0.94 |
Secondary
Difference in Mindfulness
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Yoga) Arm | Difference in Mindfulness | Baseline | 48.54 score on a scale | Standard Error 1.14 |
| Intervention (Yoga) Arm | Difference in Mindfulness | Post-program | 54.27 score on a scale | Standard Error 1.42 |
| Intervention (Yoga) Arm | Difference in Mindfulness | 2-month follow-up | 51.83 score on a scale | Standard Error 0.99 |
| No-treatment Control Arm | Difference in Mindfulness | Baseline | 48.60 score on a scale | Standard Error 1.92 |
| No-treatment Control Arm | Difference in Mindfulness | Post-program | 49.73 score on a scale | Standard Error 1.54 |
| No-treatment Control Arm | Difference in Mindfulness | 2-month follow-up | 48.56 score on a scale | Standard Error 1.49 |
Secondary
Difference in Professional Fulfillment
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Yoga) Arm | Difference in Professional Fulfillment | Baseline | 1.70 score on a scale | Standard Error 0.12 |
| Intervention (Yoga) Arm | Difference in Professional Fulfillment | Post-program | 1.35 score on a scale | Standard Error 0.14 |
| Intervention (Yoga) Arm | Difference in Professional Fulfillment | 2-month follow-up | 1.38 score on a scale | Standard Error 0.1 |
| No-treatment Control Arm | Difference in Professional Fulfillment | Baseline | 1.53 score on a scale | Standard Error 0.18 |
| No-treatment Control Arm | Difference in Professional Fulfillment | Post-program | 1.48 score on a scale | Standard Error 0.2 |
| No-treatment Control Arm | Difference in Professional Fulfillment | 2-month follow-up | 1.56 score on a scale | Standard Error 0.21 |
Secondary
Difference in Resident Well-being
Resident Well-Being Index (7 items) - scores from 0-7; higher is worse wellbeing
Time frame: Baseline, post-program, and 2-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Yoga) Arm | Difference in Resident Well-being | Baseline | 4.19 score on a scale | Standard Error 0.3 |
| Intervention (Yoga) Arm | Difference in Resident Well-being | Post-program | 3.15 score on a scale | Standard Error 0.33 |
| Intervention (Yoga) Arm | Difference in Resident Well-being | 2-month follow-up | 3.40 score on a scale | Standard Error 0.37 |
| No-treatment Control Arm | Difference in Resident Well-being | Baseline | 4.08 score on a scale | Standard Error 0.58 |
| No-treatment Control Arm | Difference in Resident Well-being | Post-program | 3.62 score on a scale | Standard Error 0.35 |
| No-treatment Control Arm | Difference in Resident Well-being | 2-month follow-up | 3.25 score on a scale | Standard Error 0.49 |
Secondary
Difference in Resilience
Resilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience
Time frame: Baseline, post-program, and 2-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Yoga) Arm | Difference in Resilience | Baseline | 70.61 score on a scale | Standard Error 2.26 |
| Intervention (Yoga) Arm | Difference in Resilience | Post-program | 76.32 score on a scale | Standard Error 1.79 |
| Intervention (Yoga) Arm | Difference in Resilience | 2-month follow-up | 72.61 score on a scale | Standard Error 1.76 |
| No-treatment Control Arm | Difference in Resilience | Baseline | 71.20 score on a scale | Standard Error 3.14 |
| No-treatment Control Arm | Difference in Resilience | Post-program | 72.07 score on a scale | Standard Error 3.02 |
| No-treatment Control Arm | Difference in Resilience | 2-month follow-up | 72.43 score on a scale | Standard Error 3.22 |
Secondary
Difference in Sleep Quality
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Yoga) Arm | Difference in Sleep Quality | Baseline | 10.38 score on a scale | Standard Error 0.62 |
| Intervention (Yoga) Arm | Difference in Sleep Quality | Post-program | 8.73 score on a scale | Standard Error 0.59 |
| Intervention (Yoga) Arm | Difference in Sleep Quality | 2-month follow-up | 8.96 score on a scale | Standard Error 0.61 |
| No-treatment Control Arm | Difference in Sleep Quality | Baseline | 11.62 score on a scale | Standard Error 1.28 |
| No-treatment Control Arm | Difference in Sleep Quality | Post-program | 9.92 score on a scale | Standard Error 0.91 |
| No-treatment Control Arm | Difference in Sleep Quality | 2-month follow-up | 8.50 score on a scale | Standard Error 1.02 |
Secondary
Difference in Stress
Perceived Stress Scale (PSS; 10 items) - scores from 0-40; higher is more stress
Time frame: Baseline, post-program, and 2-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Yoga) Arm | Difference in Stress | Baseline | 19.74 score on a scale | Standard Error 1.09 |
| Intervention (Yoga) Arm | Difference in Stress | Post-program | 16.15 score on a scale | Standard Error 1.38 |
| Intervention (Yoga) Arm | Difference in Stress | 2-month follow-up | 16.52 score on a scale | Standard Error 0.85 |
| No-treatment Control Arm | Difference in Stress | Baseline | 20.69 score on a scale | Standard Error 1.88 |
| No-treatment Control Arm | Difference in Stress | Post-program | 18.23 score on a scale | Standard Error 1.36 |
| No-treatment Control Arm | Difference in Stress | 2-month follow-up | 18.88 score on a scale | Standard Error 1.9 |
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
Time frame: Baseline, post-program, and 2-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Yoga) Arm | Differences in Professional Fulfillment - Burnout Sub-Item | 2-month follow-up | 2.31 score on a scale | Standard Error 0.11 |
| Intervention (Yoga) Arm | Differences in Professional Fulfillment - Burnout Sub-Item | Baseline | 2.26 score on a scale | Standard Error 0.13 |
| Intervention (Yoga) Arm | Differences in Professional Fulfillment - Burnout Sub-Item | Post-program | 2.47 score on a scale | Standard Error 0.15 |
| No-treatment Control Arm | Differences in Professional Fulfillment - Burnout Sub-Item | 2-month follow-up | 2.02 score on a scale | Standard Error 0.22 |
| No-treatment Control Arm | Differences in Professional Fulfillment - Burnout Sub-Item | Baseline | 1.97 score on a scale | Standard Error 0.23 |
| No-treatment Control Arm | Differences in Professional Fulfillment - Burnout Sub-Item | Post-program | 2.13 score on a scale | Standard Error 0.19 |