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AnxietyNCT03973216

Evaluating a Group-based Therapeutic Yoga Program for Burnout

A study testing A primary care group-based therapeutic yoga program in people with Anxiety and Insomnia, run by McMaster University at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety, Insomnia, Burnout, Professional
What is being tested?
A primary care group-based therapeutic yoga program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
30 Apr 2019to 31 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • no formal exclusion criteria

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Clairhurst Medical Centre

    Toronto, Ontario, M5G 3S3

Other trials in Canada

About this study

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).

Read the 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.

Being tested
A primary care group-based therapeutic yoga program
Keywords
Anxiety, Yoga, Mindfulness, Group-based therapy
Medical subject headings
Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Burnout, Professional, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A primary care group-based therapeutic yoga programBehavioural

    The intervention includes therapeutic yoga training and education sessions on benefits of yoga and effects of stress on the body.

Study groups in NCT03973216
Study groupRoleWhat they receive
A primary care group-based therapeutic yoga programExperimentalA primary care care group-based therapeutic yoga program that consists of 9 sessions.
Receives: Behavioral: A primary care group-based therapeutic yoga program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Change from baseline each week until 9 weeks and at 8 months post-baseline

Secondary outcomes (9)

  1. 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)

    Measured: Change from baseline each week until 9 weeks and at 8 months post-baseline

  2. 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.

    Measured: Change from baseline each week until 9 weeks and at 8 months post-baseline

  3. 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).

    Measured: Change from baseline each week until 9 weeks and at 8 months post-baseline

  4. 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).

    Measured: Only at baseline

  5. 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.

    Measured: Change from baseline each week until 9 weeks and at 8 months post-baseline

  6. 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).

    Measured: Change from baseline each week until 9 weeks and at 8 months post-baseline

  7. 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.

    Measured: Change from baseline each week until 9 weeks and at 8 months post-baseline

  8. 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).

    Measured: Change from baseline each week until 9 weeks and at 8 months post-baseline

  9. 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.

    Measured: Change from baseline each week until 9 weeks and at 8 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start30 Apr 2019 (estimated)
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion31 May 2022 (estimated)

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03973216
Sponsor's protocol ID
Yoga MD for burnout
Status last verified
Apr 2021
First submitted
22 May 2019
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16717171

  • 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.

    PubMed 28088111

  • 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.

    PubMed 17339617

  • 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.

    PubMed 11438246

  • 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

  • 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.

    PubMed 9635069

  • 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.

    PubMed 26951403

  • 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.

    PubMed 15550799

  • Sheehan, D.V. (1983) The Anxiety Disease. Scribner, New York.

  • 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.

    PubMed 21584907

  • 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

  • Grygiel P, Humenny G, Rebisz S. Using the De Jong Gierveld Loneliness Scale With Early Adolescents: Factor Structure, Reliability, Stability, and External Validity. Assessment. 2019 Mar;26(2):151-165. doi: 10.1177/1073191116682298. Epub 2016 Dec 8.

    PubMed 27932403

  • Alvarez E, Sutton A, Barton B, Vaidya S. Evaluating a group-based Yoga of Stress Resilience programme: a pragmatic before-after interventional study protocol. BMJ Open. 2020 Mar 31;10(3):e035862. doi: 10.1136/bmjopen-2019-035862.

    PubMed 32234747

Questions about this trial

What is this clinical trial studying?

A study testing A primary care group-based therapeutic yoga program in people with Anxiety and Insomnia, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Generalized Anxiety Disorder - 7 (GAD-7) (time frame: Change from baseline each week until 9 weeks and at 8 months post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03973216, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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