Evaluating a Group-based Therapeutic Yoga Program for Burnout

April 2, 2021 updated by: Elizabeth Alvarez, McMaster University
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 3S3
        • Clairhurst Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no formal exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from baseline each week until 9 weeks and at 8 months post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline each week until 9 weeks and at 8 months post-baseline
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.
Change from baseline each week until 9 weeks and at 8 months post-baseline
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).
Change from baseline each week until 9 weeks and at 8 months post-baseline
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).
Only at baseline
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.
Change from baseline each week until 9 weeks and at 8 months post-baseline
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).
Change from baseline each week until 9 weeks and at 8 months post-baseline
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.
Change from baseline each week until 9 weeks and at 8 months post-baseline
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).
Change from baseline each week until 9 weeks and at 8 months post-baseline
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.
Change from baseline each week until 9 weeks and at 8 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Elizabeth Alvarez, MD, McMaster University
  • Principal Investigator: Arielle Sutton, MPH, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 30, 2019

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

June 1, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yoga MD for burnout

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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