Clinical trial NCT03973216: Evaluating a Group-based Therapeutic Yoga Program for Burnout
Official title: Evaluating a Group-based Therapeutic Yoga Program for Burnout
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety
Insomnia
Burnout, Professional
Depression
Loneliness
Keywords: Anxiety
Yoga
Mindfulness
Group-based therapy
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* no formal exclusion criteria

Primary outcomes:
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: Change from baseline each week until 9 weeks and at 8 months post-baseline
Secondary outcomes:
measure: The Insomnia Severity Index
timeFrame: Change from baseline each week until 9 weeks and at 8 months post-baseline
measure: The Perceived Stress Scale
timeFrame: Change from baseline each week until 9 weeks and at 8 months post-baseline
measure: The Maslach Burnout Inventory
timeFrame: Change from baseline each week until 9 weeks and at 8 months post-baseline
measure: The Adverse Childhood Events (ACE)
timeFrame: Only at baseline
measure: Patient Heath Questionnaire 9 (PHQ-9) for depression
timeFrame: Change from baseline each week until 9 weeks and at 8 months post-baseline
measure: The Sheehan Disability Scale
timeFrame: Change from baseline each week until 9 weeks and at 8 months post-baseline
measure: The short-form Self-Compassion Scale
timeFrame: Change from baseline each week until 9 weeks and at 8 months post-baseline
measure: The Readiness for Change Scale
timeFrame: Change from baseline each week until 9 weeks and at 8 months post-baseline
measure: The DeJong Gierveld 6-item Loneliness Scale
timeFrame: Change from baseline each week until 9 weeks and at 8 months post-baseline
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Clairhurst Medical Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Elizabeth Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Arielle Sutton, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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citation: Cohen, S. (1994). Perceived Stress Scale. Psychology, 1-3. https://doi.org/10.1037/t02889-000
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
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.
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.
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.
citation: Sheehan, D.V. (1983) The Anxiety Disease. Scribner, New York.
citation: 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.
citation: 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
citation: 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.
citation: 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.