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Completed

NCT Number: NCT03687450

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

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.

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Key information

Conditions

Burnout, Professional Anxiety Anxiety Disorders Behavior Behavioral Symptoms Burnout, Psychological Depression Mental Disorders Occupational Diseases Occupational Stress Stress Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Attending the Yoga Program

    Time frame: 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 outcomes

  1. Difference in Burnout

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Kripalu Center for Yoga and Health

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2018
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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