Evaluating a Group-based Therapeutic Yoga Program for Burnout

NCT ID: NCT03973216

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Insomnia Burnout, Professional Depression Loneliness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A primary care group-based therapeutic yoga program

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

Group Type EXPERIMENTAL

A primary care group-based therapeutic yoga program

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

McMaster University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elizabeth Alvarez

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elizabeth Alvarez, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Arielle Sutton, MPH

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clairhurst Medical Centre

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16717171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28088111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17339617 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11438246 (View on PubMed)

Cohen, S. (1994). Perceived Stress Scale. Psychology, 1-3. https://doi.org/10.1037/t02889-000

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 9635069 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26951403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15550799 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 21584907 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 27932403 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32234747 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Yoga MD for burnout

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tele-Yoga Therapy for Chronic Pain
NCT04457388 COMPLETED NA