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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03687450
Collaborator
Kripalu Center for Yoga and Health (Other)
56
1
2
18
3.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: RISE yoga-based program
N/A

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.

Study Design

Study Type:
Interventional
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 :
Nov 1, 2018
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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

  2. 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

  3. 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

  4. Difference in Resilience [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

  • Principal Investigator: Sat Bir Khalsa, PhD, Brigham and Women's Hospital

Study Documents (Full-Text)

More Information

Publications

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:
Sep 27, 2018
Last Update Posted:
Jul 23, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Assistant Professor of Medicine, Brigham and Women's Hospital
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Period Title: Overall Study
STARTED 38 18
Post-Program Follow-Up 28 15
Two-month Follow-up 26 16
COMPLETED 26 16
NOT COMPLETED 12 2

Baseline Characteristics

Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm Total
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class. Total of all reporting groups
Overall Participants 28 16 44
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
29.3
29.1
29.2
Sex: Female, Male (Count of Participants)
Female
21
75%
15
93.8%
36
81.8%
Male
7
25%
1
6.3%
8
18.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
2
7.1%
1
6.3%
3
6.8%
Not Hispanic or Latino
26
92.9%
14
87.5%
40
90.9%
Unknown or Not Reported
0
0%
1
6.3%
1
2.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
3.6%
0
0%
1
2.3%
Asian
7
25%
4
25%
11
25%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
1
3.6%
0
0%
1
2.3%
White
18
64.3%
10
62.5%
28
63.6%
More than one race
0
0%
2
12.5%
2
4.5%
Unknown or Not Reported
1
3.6%
0
0%
1
2.3%
Year in Training (Count of Participants)
1st year
9
32.1%
3
18.8%
12
27.3%
2nd year
6
21.4%
5
31.3%
11
25%
3rd year
8
28.6%
3
18.8%
11
25%
4th year and above
5
17.9%
5
31.3%
10
22.7%
Specialty (Count of Participants)
Internal Medicine
12
42.9%
8
50%
20
45.5%
OB/GYN
3
10.7%
2
12.5%
5
11.4%
Diagnostic Radiology
3
10.7%
2
12.5%
5
11.4%
Emergency Medicine
2
7.1%
0
0%
2
4.5%
Psychiatry
4
14.3%
2
12.5%
6
13.6%
Medicine-Pediatrics
1
3.6%
0
0%
1
2.3%
Anesthesiology
3
10.7%
1
6.3%
4
9.1%
Physical Medicine & Rehabilitation
0
0%
1
6.3%
1
2.3%

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
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/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Measure Participants 28 0
Mean (Standard Deviation) [visual analogue scale, 0 to 100]
28.9
(25.6)
2. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Measure Participants 28 16
Baseline
6.23
(0.52)
6.33
(0.92)
Post-program
5.65
(0.50)
6.83
(0.66)
2-month follow-up
5.72
(0.53)
6.43
(0.99)
3. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Measure Participants 28 16
Baseline
1.70
(0.12)
1.53
(0.18)
Post-program
1.35
(0.14)
1.48
(0.20)
2-month follow-up
1.38
(0.10)
1.56
(0.21)
4. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Measure Participants 28 16
Baseline
4.19
(0.30)
4.08
(0.58)
Post-program
3.15
(0.33)
3.62
(0.35)
2-month follow-up
3.40
(0.37)
3.25
(0.49)
5. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Measure Participants 28 15
Baseline
70.61
(2.26)
71.20
(3.14)
Post-program
76.32
(1.79)
72.07
(3.02)
2-month follow-up
72.61
(1.76)
72.43
(3.22)
6. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Measure Participants 28 16
Baseline
48.54
(1.14)
48.60
(1.92)
Post-program
54.27
(1.42)
49.73
(1.54)
2-month follow-up
51.83
(0.99)
48.56
(1.49)
7. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Measure Participants 28 16
Baseline
19.74
(1.09)
20.69
(1.88)
Post-program
16.15
(1.38)
18.23
(1.36)
2-month follow-up
16.52
(0.85)
18.88
(1.90)
8. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Measure Participants 28 16
Baseline
7.56
(0.64)
7.15
(1.13)
Post-program
6.48
(0.54)
7.23
(0.75)
2-month follow-up
7.24
(0.61)
7.81
(0.94)
9. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Measure Participants 28 16
Baseline
10.38
(0.62)
11.62
(1.28)
Post-program
8.73
(0.59)
9.92
(0.91)
2-month follow-up
8.96
(0.61)
8.50
(1.02)
10. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Measure Participants 28 16
Baseline
9.65
(0.60)
10.00
(1.00)
Post-program
8.54
(0.59)
9.15
(0.94)
2-month follow-up
8.96
(0.57)
7.94
(0.81)
11. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
Measure Participants 28 16
Baseline
2.26
(0.13)
1.97
(0.23)
Post-program
2.47
(0.15)
2.13
(0.19)
2-month follow-up
2.31
(0.11)
2.02
(0.22)

Adverse Events

Time Frame 2 months
Adverse Event Reporting Description
Arm/Group Title Intervention (Yoga) Arm No-treatment Control Arm
Arm/Group Description 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. This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
All Cause Mortality
Intervention (Yoga) Arm No-treatment Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/38 (0%) 0/18 (0%)
Serious Adverse Events
Intervention (Yoga) Arm No-treatment Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/38 (0%) 0/18 (0%)
Other (Not Including Serious) Adverse Events
Intervention (Yoga) Arm No-treatment Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/38 (0%) 0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Julia Loewenthal, MD
Organization Brigham and Women's Hospital
Phone 6177325500
Email jloewenthal@bwh.harvard.edu
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:
Sep 27, 2018
Last Update Posted:
Jul 23, 2020
Last Verified:
Jul 1, 2020