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NCT03687450

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

Completed NA Results posted Last updated 23 July 2020
What this trial tests

NA trial testing RISE yoga-based program in Burnout, Professional in 56 participants. Completed in 1 May 2020.

Timeline
1 November 2018
Primary endpoint
1 May 2020
1 May 2020

Quick facts

Lead sponsorBrigham and Women's Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment56
Start date1 November 2018
Primary completion1 May 2020
Estimated completion1 May 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brigham and Women's Hospital

Who can join

18 and older, any sex, with Burnout, Professional or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Attending the Yoga Program Primary · 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.

GroupValue95% CI
Intervention (Yoga) Arm28.9± 25.6
Difference in Burnout Secondary · Post-program and 2-month follow-up

Maslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout

Baseline
GroupValue95% CI
Intervention (Yoga) Arm6.23± 0.52
No-treatment Control Arm6.33± 0.92
Post-program
GroupValue95% CI
Intervention (Yoga) Arm5.65± 0.50
No-treatment Control Arm6.83± 0.66
2-month follow-up
GroupValue95% CI
Intervention (Yoga) Arm5.72± 0.53
No-treatment Control Arm6.43± 0.99
Difference in Professional Fulfillment Secondary · 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

Baseline
GroupValue95% CI
Intervention (Yoga) Arm1.70± 0.12
No-treatment Control Arm1.53± 0.18
Post-program
GroupValue95% CI
Intervention (Yoga) Arm1.35± 0.14
No-treatment Control Arm1.48± 0.20
2-month follow-up
GroupValue95% CI
Intervention (Yoga) Arm1.38± 0.10
No-treatment Control Arm1.56± 0.21
Difference in Resident Well-being Secondary · Baseline, post-program, and 2-month follow-up

Resident Well-Being Index (7 items) - scores from 0-7; higher is worse wellbeing

Baseline
GroupValue95% CI
Intervention (Yoga) Arm4.19± 0.30
No-treatment Control Arm4.08± 0.58
Post-program
GroupValue95% CI
Intervention (Yoga) Arm3.15± 0.33
No-treatment Control Arm3.62± 0.35
2-month follow-up
GroupValue95% CI
Intervention (Yoga) Arm3.40± 0.37
No-treatment Control Arm3.25± 0.49
Difference in Resilience Secondary · Baseline, post-program, and 2-month follow-up

Resilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience

Baseline
GroupValue95% CI
Intervention (Yoga) Arm70.61± 2.26
No-treatment Control Arm71.20± 3.14
Post-program
GroupValue95% CI
Intervention (Yoga) Arm76.32± 1.79
No-treatment Control Arm72.07± 3.02
2-month follow-up
GroupValue95% CI
Intervention (Yoga) Arm72.61± 1.76
No-treatment Control Arm72.43± 3.22
Difference in Mindfulness Secondary · 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

Baseline
GroupValue95% CI
Intervention (Yoga) Arm48.54± 1.14
No-treatment Control Arm48.60± 1.92
Post-program
GroupValue95% CI
Intervention (Yoga) Arm54.27± 1.42
No-treatment Control Arm49.73± 1.54
2-month follow-up
GroupValue95% CI
Intervention (Yoga) Arm51.83± 0.99
No-treatment Control Arm48.56± 1.49
Difference in Stress Secondary · Baseline, post-program, and 2-month follow-up

Perceived Stress Scale (PSS; 10 items) - scores from 0-40; higher is more stress

Baseline
GroupValue95% CI
Intervention (Yoga) Arm19.74± 1.09
No-treatment Control Arm20.69± 1.88
Post-program
GroupValue95% CI
Intervention (Yoga) Arm16.15± 1.38
No-treatment Control Arm18.23± 1.36
2-month follow-up
GroupValue95% CI
Intervention (Yoga) Arm16.52± 0.85
No-treatment Control Arm18.88± 1.90
Difference in Depression Secondary · 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

Baseline
GroupValue95% CI
Intervention (Yoga) Arm7.56± 0.64
No-treatment Control Arm7.15± 1.13
Post-program
GroupValue95% CI
Intervention (Yoga) Arm6.48± 0.54
No-treatment Control Arm7.23± 0.75
2-month follow-up
GroupValue95% CI
Intervention (Yoga) Arm7.24± 0.61
No-treatment Control Arm7.81± 0.94
Difference in Sleep Quality Secondary · Baseline, post-program, and 2-month follow-up

PROMIS Sleep Disturbance (short form, 4 items) - scores from 4-20, higher is more sleep disturbance

Baseline
GroupValue95% CI
Intervention (Yoga) Arm10.38± 0.62
No-treatment Control Arm11.62± 1.28
Post-program
GroupValue95% CI
Intervention (Yoga) Arm8.73± 0.59
No-treatment Control Arm9.92± 0.91
2-month follow-up
GroupValue95% CI
Intervention (Yoga) Arm8.96± 0.61
No-treatment Control Arm8.50± 1.02
Difference in Anxiety Secondary · 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

Baseline
GroupValue95% CI
Intervention (Yoga) Arm9.65± 0.60
No-treatment Control Arm10.00± 1.00
Post-program
GroupValue95% CI
Intervention (Yoga) Arm8.54± 0.59
No-treatment Control Arm9.15± 0.94
2-month follow-up
GroupValue95% CI
Intervention (Yoga) Arm8.96± 0.57
No-treatment Control Arm7.94± 0.81
Differences in Professional Fulfillment - Burnout Sub-Item Secondary · 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

Baseline
GroupValue95% CI
Intervention (Yoga) Arm2.26± 0.13
No-treatment Control Arm1.97± 0.23
Post-program
GroupValue95% CI
Intervention (Yoga) Arm2.47± 0.15
No-treatment Control Arm2.13± 0.19
2-month follow-up
GroupValue95% CI
Intervention (Yoga) Arm2.31± 0.11
No-treatment Control Arm2.02± 0.22

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mindfulness-based psychological interventions for improving mental well-being in medical students and junior doctors.
    Sekhar P, Tee QX, Ashraf G, Trinh D, et al · · 2021 · cited 23× · PMID 34890044 · DOI 10.1002/14651858.cd013740.pub2
  2. Evaluation of a Yoga-Based Mind-Body Intervention for Resident Physicians: A Randomized Clinical Trial.
    Loewenthal J, Dyer NL, Lipsyc-Sharf M, Borden S, et al · · 2021 · cited 17× · PMID 33786209 · DOI 10.1177/21649561211001038
  3. Development and Feasibility Testing of a Brief Yoga Module on Well-being and Cognition of Postgraduate Mental Healthcare Students in Tertiary Settings.
    Hakkim A, Jagannathan A, Bhargav H, Jasti N, et al · · 2021 · cited 1× · PMID 35017865 · DOI 10.4103/ijoy.ijoy_87_21

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Other recruiting trials for Burnout, Professional

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing