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Evaluating a Group-based Therapeutic Yoga Program for Burnout

Primary Purpose

Anxiety, Insomnia, Burnout, Professional

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
A primary care group-based therapeutic yoga program
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Yoga, Mindfulness, Group-based therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • no formal exclusion criteria

Sites / Locations

  • Clairhurst Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A primary care group-based therapeutic yoga program

Arm Description

A primary care care group-based therapeutic yoga program that consists of 9 sessions.

Outcomes

Primary Outcome Measures

Generalized Anxiety Disorder - 7 (GAD-7)
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

The Insomnia Severity Index
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)
The Perceived Stress Scale
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.
The Maslach Burnout Inventory
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).
The Adverse Childhood Events (ACE)
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).
Patient Heath Questionnaire 9 (PHQ-9) for depression
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.
The Sheehan Disability Scale
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).
The short-form Self-Compassion Scale
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.
The Readiness for Change Scale
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).
The DeJong Gierveld 6-item Loneliness Scale
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.

Full Information

First Posted
May 22, 2019
Last Updated
April 2, 2021
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT03973216
Brief Title
Evaluating a Group-based Therapeutic Yoga Program for Burnout
Official Title
Evaluating a Group-based Therapeutic Yoga Program for Burnout
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
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.
Study Start Date
April 30, 2019 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Insomnia, Burnout, Professional, Depression, Loneliness
Keywords
Anxiety, Yoga, Mindfulness, Group-based therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A primary care group-based therapeutic yoga program
Arm Type
Experimental
Arm Description
A primary care care group-based therapeutic yoga program that consists of 9 sessions.
Intervention Type
Behavioral
Intervention Name(s)
A primary care group-based therapeutic yoga program
Intervention Description
The intervention includes therapeutic yoga training and education sessions on benefits of yoga and effects of stress on the body.
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder - 7 (GAD-7)
Description
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).
Time Frame
Change from baseline each week until 9 weeks and at 8 months post-baseline
Secondary Outcome Measure Information:
Title
The Insomnia Severity Index
Description
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)
Time Frame
Change from baseline each week until 9 weeks and at 8 months post-baseline
Title
The Perceived Stress Scale
Description
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.
Time Frame
Change from baseline each week until 9 weeks and at 8 months post-baseline
Title
The Maslach Burnout Inventory
Description
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).
Time Frame
Change from baseline each week until 9 weeks and at 8 months post-baseline
Title
The Adverse Childhood Events (ACE)
Description
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).
Time Frame
Only at baseline
Title
Patient Heath Questionnaire 9 (PHQ-9) for depression
Description
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.
Time Frame
Change from baseline each week until 9 weeks and at 8 months post-baseline
Title
The Sheehan Disability Scale
Description
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).
Time Frame
Change from baseline each week until 9 weeks and at 8 months post-baseline
Title
The short-form Self-Compassion Scale
Description
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.
Time Frame
Change from baseline each week until 9 weeks and at 8 months post-baseline
Title
The Readiness for Change Scale
Description
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).
Time Frame
Change from baseline each week until 9 weeks and at 8 months post-baseline
Title
The DeJong Gierveld 6-item Loneliness Scale
Description
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.
Time Frame
Change from baseline each week until 9 weeks and at 8 months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18 Must be enrolled in therapeutic yoga program Exclusion Criteria: no formal exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Alvarez, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arielle Sutton, MPH
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clairhurst Medical Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 3S3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16717171
Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Results Reference
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PubMed Identifier
28088111
Citation
Hinz A, Klein AM, Brahler E, Glaesmer H, Luck T, Riedel-Heller SG, Wirkner K, Hilbert A. Psychometric evaluation of the Generalized Anxiety Disorder Screener GAD-7, based on a large German general population sample. J Affect Disord. 2017 Mar 1;210:338-344. doi: 10.1016/j.jad.2016.12.012. Epub 2016 Dec 18.
Results Reference
background
PubMed Identifier
17339617
Citation
Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
Results Reference
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PubMed Identifier
11438246
Citation
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
Results Reference
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Citation
Cohen, S. (1994). Perceived Stress Scale. Psychology, 1-3. https://doi.org/10.1037/t02889-000
Results Reference
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Citation
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
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PubMed Identifier
9635069
Citation
Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
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PubMed Identifier
26951403
Citation
Kohrt BA, Luitel NP, Acharya P, Jordans MJ. Detection of depression in low resource settings: validation of the Patient Health Questionnaire (PHQ-9) and cultural concepts of distress in Nepal. BMC Psychiatry. 2016 Mar 8;16:58. doi: 10.1186/s12888-016-0768-y.
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PubMed Identifier
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Citation
Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.
Results Reference
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Sheehan, D.V. (1983) The Anxiety Disease. Scribner, New York.
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Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
Results Reference
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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
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Evaluating a Group-based Therapeutic Yoga Program for Burnout

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