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| Name | Class |
|---|---|
| Kripalu Center for Yoga and Health | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Yoga) Arm | Experimental | Received a weekly 60-minute yoga-based class over 6 weeks with direction for a 5-10 minute daily home practice. |
|
| No-treatment Control Arm | No Intervention | Waitlist control-- group received one session of yoga-based class at the completion of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RISE yoga-based program | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sat Bir Khalsa, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7850498 | Background | Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78. | |
| 16443717 | Background | 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. doi: 10.1177/1073191105283504. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants included in analysis were those who completed ANY follow-up survey (post-program or two-month follow-up). This includes 28 who completed post-program follow-up in intervention arm and 16 who completed two-month follow-up in control arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | visual analogue scale, 0 to 100 | Post-program |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Loewenthal, MD | Brigham and Women's Hospital | 6177325500 | jloewenthal@bwh.harvard.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 4, 2019 | May 30, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D002055 | Burnout, Professional |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000073397 | Occupational Stress |
| D009784 | Occupational Diseases |
| D000077062 | Burnout, Psychological |
| D013315 | Stress, Psychological |
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|
| 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 |
| 22623334 | Background | 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. |
| 27078186 | Background | 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. |
| 6668417 | Background | Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. |
| 19802645 | Background | 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. |
| 22362127 | Background | 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. |
| 29196982 | Background | 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. |
| 16004657 | Background | 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. doi: 10.1348/014466505X29657. |
| 24931848 | Background | 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. |
| 3397865 | Background | 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. doi: 10.1037//0022-3514.54.6.1063. |
| 22250775 | Background | 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. |
| 24701315 | Background | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Year in Training | Count of Participants | Participants |
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| Specialty | Count of Participants | Participants |
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| OG001 | 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. |
|
|
| Secondary | Difference in Burnout | Maslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout | Posted | Mean | Standard Error | score on a scale | 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 | Posted | Mean | Standard Error | score on a scale | 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 | Posted | Mean | Standard Error | score on a scale | 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 | Posted | Mean | Standard Error | score on a scale | 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 | Posted | Mean | Standard Error | score on a scale | 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 | Posted | Mean | Standard Error | score on a scale | 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 | Posted | Mean | Standard Error | score on a scale | Baseline, post-program, and 2-month follow-up |
|
|
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| Secondary | Difference in Sleep Quality | PROMIS Sleep Disturbance (short form, 4 items) - scores from 4-20, higher is more sleep disturbance | Posted | Mean | Standard Error | score on a scale | 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 | Posted | Mean | Standard Error | score on a scale | 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 | Posted | Mean | Standard Error | score on a scale | Baseline, post-program, and 2-month follow-up |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| 2-month follow-up |
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| 2-month follow-up |
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| 2-month follow-up |
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| 2-month follow-up |
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| 2-month follow-up |
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| 2-month follow-up |
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| 2-month follow-up |
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| 2-month follow-up |
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| 2-month follow-up |
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| 2-month follow-up |
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