Evaluating a Group-based Therapeutic Yoga Program for Burnout

NCT03973216 | Withdrawn

• 1 other identifier: Yoga MD for burnout
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety; Insomnia; Burnout, Professional; Depression; Loneliness

Keywords

Anxiety; Yoga; Mindfulness; Group-based therapy

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (9)

• The Insomnia Severity Index

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

• The Perceived Stress Scale

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

• The Maslach Burnout Inventory

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

• The Adverse Childhood Events (ACE)

  Only at baseline

• Patient Heath Questionnaire 9 (PHQ-9) for depression

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

Study Arms (1)

A primary care group-based therapeutic yoga program

EXPERIMENTAL

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

Behavioral: A primary care group-based therapeutic yoga program

Interventions

A primary care group-based therapeutic yoga program BEHAVIORAL

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

A primary care group-based therapeutic yoga program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Clairhurst Medical Centre

Toronto, Ontario, M5G 3S3, Canada

Location

Related Publications (14)

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 28088111 BACKGROUND

• 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.

  PMID: 17339617 BACKGROUND

• 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.

  PMID: 11438246 BACKGROUND

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

  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

  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.

  PMID: 9635069 BACKGROUND

• 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.

  PMID: 26951403 BACKGROUND

• 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.

  PMID: 15550799 BACKGROUND

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

  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.

  PMID: 21584907 BACKGROUND

• 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

  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.

  PMID: 27932403 BACKGROUND

• 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.

  PMID: 32234747 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Burnout, Professional; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Elizabeth Alvarez, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Arielle Sutton, MPH

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 4, 2019
• Study Start: April 30, 2019
• Primary Completion: December 1, 2021
• Study Completion: May 31, 2022
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)