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Evaluating a Group-based Therapeutic Yoga Program for Burnout

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ClinicalTrials.gov Identifier: NCT03973216
Recruitment Status : Withdrawn (COVID-19 caused the group format to shift, therefore the intervention was not delivered in the same manner as the one described in the proposal. The study was stopped as the intervention may not be delivered as planned even following COVID-19.)
First Posted : June 4, 2019
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Elizabeth Alvarez, McMaster University

Brief Summary:
This study is evaluating a group-based therapeutic yoga program for burnout. This study aims to understand the feasibility of running the program (i.e. of recruiting participants, the resources required to run the program, etc) and the effectiveness of the program (i.e. in decreasing participants' mental health symptoms).

Condition or disease Intervention/treatment Phase
Anxiety Insomnia Burnout, Professional Depression Loneliness Behavioral: A primary care group-based therapeutic yoga program Not Applicable

Detailed Description:

A primary care group-based therapeutic yoga program, the Yoga MD program, was developed by a primary care / emergency physician practicing in Toronto, Ontario. The program was started in 2014 and is run through a medical centre in Toronto, Ontario. The purposes of the program are to understand:

  • key concepts of yoga, mindfulness, compassion, acceptance and how these can help with personal transformation
  • how stress is carried in the body (embodiment of stress) and how stress manifests as anxiety, pain, or other symptoms
  • what happens when stress accumulates in the body
  • the role of self-compassion in the response to stress
  • how to cope with difficult emotions that may contribute to stress
  • how to deal with difficult people and trying relationships
  • the importance of connecting with, and caring for ourselves to reduce accumulated stress
  • how to solidify healthier patterns to build resilience to stress faced in daily life.

This study evaluates the 9 weekly sessions using a before-after interventional design. Participants have data collected at baseline, and at 9 weeks and 8 months after the yoga program ends, and changes in mental health outcomes are observed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study evaluates the effect of the intervention using a single group, before-after study model. The subjects will be evaluated at baseline and followed longitudinally, until study completion and a long-term followup.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating a Group-based Therapeutic Yoga Program for Burnout
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: A primary care group-based therapeutic yoga program
A primary care care group-based therapeutic yoga program that consists of 9 sessions.
Behavioral: A primary care group-based therapeutic yoga program
The intervention includes therapeutic yoga training and education sessions on benefits of yoga and effects of stress on the body.




Primary Outcome Measures :
  1. Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Change from baseline each week until 9 weeks and at 8 months post-baseline ]
    The GAD-7 is a validated instrument for the diagnosis and treatment response of anxiety disorders (Spitzer et al., 2006; Hinz et al., 2017). It is comprised of 7 questions with 4 answer options, ranging from "not at all" to "nearly every day"and scored 0-3 with a total score ranging from 0-21 (Spitzer et al., 2006). Scores of 5-9, 10-14, and 15-21 represent mild, moderate and severe generalized anxiety disorder, respectively. In the primary care setting, the GAD-7 has high diagnostic validity, with a threshold of 10 exhibiting a sensitivity of 89% and specificity of 82% for generalized anxiety disorder (Spitzer et al., 2006). Other conditions related to generalized anxiety disorder including panic disorder, social anxiety disorder and post-traumatic stress disorder have also been sensitive to a GAD-7 score of 10 (Kroenke et al., 2007).


Secondary Outcome Measures :
  1. The Insomnia Severity Index [ Time Frame: Change from baseline each week until 9 weeks and at 8 months post-baseline ]

    The Insomnia Severity Index, a 7-item scale, was identified as the most fitting validated scale to identify insomnia symptoms (Bastien et al., 2001). Each of the questions is measured on a scale of 0-4 and the answers are added up to get a total score.

    Total score categories:

    0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)


  2. The Perceived Stress Scale [ Time Frame: Change from baseline each week until 9 weeks and at 8 months post-baseline ]
    The Perceived Stress Scale contains ten items and is designed to measure the degree to which situations in one's life are appraised as stressful (Cohen, 1994). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of stress.

  3. The Maslach Burnout Inventory [ Time Frame: Change from baseline each week until 9 weeks and at 8 months post-baseline ]
    The Maslach Burnout Inventory is a 22- item scale that is divided into three sub-scales: Emotional Exhaustion, Depersonalization, and Personal Accomplishment. Items are scored using a 7 level frequency scale from "never" to "daily." The 9-item Emotional Exhaustion scale measures feelings of being emotionally overextended. Scores from 0-16 represent low burnout, 17-29 represent moderate burnout, and 30 and over is high burnout. The 5-item Depersonalization scale measures a dehumanization in interpersonal interactions/ Scores of 0-5 represent low burnout, 6-11 represent moderate burnout and 12 or over represent high burnout. The 8-item Personal Accomplishment scale measures feelings of successful achievement in one's work with people. Scores of 33 or less represent high burnout, 34-39 represent moderate burnout, and 40 or over represent low burnout (Maslach, Leiter & Jackson, 1996).

  4. The Adverse Childhood Events (ACE) [ Time Frame: Only at baseline ]
    The Adverse Childhood Events (ACE) Scale includes 10 questions about childhood abuse and exposure to forms of household dysfunction before the age of 18 There is a maximum score of 10, which indicates a greater number of adverse childhood events. The higher your ACE score, the higher your risk of health and social problems (Felitti et al., 1998).

  5. Patient Heath Questionnaire 9 (PHQ-9) for depression [ Time Frame: Change from baseline each week until 9 weeks and at 8 months post-baseline ]
    The Patient Health Questionnaire-9 (PHQ-9) is made up of nine questions and is diagnostic for depression. Importantly, the PHQ-9 has also been found to be sensitive to change for monitoring of treatment outcomes (Kohrt et al, 2016; Lowe et al, 2004). The PHQ-9 asks participants, "Over the last 2 weeks, how often have you been bothered by any of the following problems?" All answers have four options ranging from "not at all," "several days," more than half the days," or "nearly every day" for a number of symptoms related to depression. Major depression and other depressive syndromes are diagnosed based on answers of "more than half the days" or "nearly every day" to "Little interest or pleasure in doing things" or "Feeling down, depressed, or hopeless" plus 2-5 or more of the other symptoms.

  6. The Sheehan Disability Scale [ Time Frame: Change from baseline each week until 9 weeks and at 8 months post-baseline ]
    The Sheehan Disability Scale is a 3-item scale that assesses impairment in three areas: work, social and family (Sheehan, 1983). The questions inquire about the degree to which one's burnout, panic, anxiety, phobia, or depressive symptoms interfere with work/school, social life, and family. The scale ranges from 0 (not at all) to 10 (extremely), with higher scores indicating greater disability. The 3 items can also be summed into a single dimensional measure of global functional impairment that rages from 0 (unimpaired) to 30 (highly impaired).

  7. The short-form Self-Compassion Scale [ Time Frame: Change from baseline each week until 9 weeks and at 8 months post-baseline ]
    The short-form Self-Compassion Scale includes twelve items and is comparable to the longer, 26-item, scale. The short form includes two items each on self-kindness, self-judgement, common humanity, isolation, therapeutic yoga and overidentified items.(Raes, Pommier, Neff, & Van Gucht, 2011). The scale ranges from 1- 5, with 1 indicating almost never, and 5 indicating almost always. Subscale scores are computed by calculating the mean of subscale item responses and total mean scores are also calculated for a total self-compassion score.

  8. The Readiness for Change Scale [ Time Frame: Change from baseline each week until 9 weeks and at 8 months post-baseline ]
    The Readiness for Change Scale contains 3 questions regarding making a change in one's life. It is based on a 10-point scale, and scores range from 0-30. Lower numbers indicate less readiness, and the higher numbers indicate greater readiness for change (Center for Substance Abuse Treatment, 1999).

  9. The DeJong Gierveld 6-item Loneliness Scale [ Time Frame: Change from baseline each week until 9 weeks and at 8 months post-baseline ]
    The DeJong Gierveld 6-item Loneliness Scale captures both emotional loneliness (missing an intimate relationship) and social loneliness (missing a wider social network) (Gierveld et al., 2006; Grygiel et al., 2016). Answer choices include: "Yes", "More or Less", and "No". On the negatively worded items, the neutral and positive answers are scored as "1". Therefore, on questions 1-3 score Yes=1, More or less=1, and No=0. On the positively worded items, the neutral and negative answers are scored as "1". Scores range from 0-6, with higher scores indicating higher levels of loneliness.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18
  • Must be enrolled in therapeutic yoga program

Exclusion Criteria:

  • no formal exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973216


Locations
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Canada, Ontario
Clairhurst Medical Centre
Toronto, Ontario, Canada, M5G 3S3
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Elizabeth Alvarez, MD McMaster University
Principal Investigator: Arielle Sutton, MPH McMaster University
Publications:
Cohen, S. (1994). Perceived Stress Scale. Psychology, 1-3. https://doi.org/10.1037/t02889-000
Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach Burnout Inventory Manual. Evaluating Stress: A Book of Resources. https://doi.org/10.1038/oby.2012.27
Sheehan, D.V. (1983) The Anxiety Disease. Scribner, New York.
Gierveld, J. D. J., & Tilburg, T. V. (2006). A 6-Item Scale for Overall, Emotional, and Social Loneliness: Confirmatory Tests on Survey Data. Research on Aging, 28(5), 582-598. https://doi.org/10.1177/0164027506289723

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elizabeth Alvarez, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier: NCT03973216    
Other Study ID Numbers: Yoga MD for burnout
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth Alvarez, McMaster University:
Anxiety
Yoga
Mindfulness
Group-based therapy
Additional relevant MeSH terms:
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Burnout, Professional
Burnout, Psychological
Behavioral Symptoms
Stress, Psychological
Occupational Stress
Occupational Diseases