| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety Insomnia Burnout, Professional Depression Loneliness | Behavioral: A primary care group-based therapeutic yoga program | Not Applicable |
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:
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluating a Group-based Therapeutic Yoga Program for Burnout |
| Estimated Study Start Date : | April 30, 2019 |
| Estimated Primary Completion Date : | December 1, 2021 |
| Estimated Study Completion Date : | May 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: A primary care group-based therapeutic yoga program
A primary care care group-based therapeutic yoga program that consists of 9 sessions.
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Behavioral: 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.
|
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)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Canada, Ontario | |
| Clairhurst Medical Centre | |
| Toronto, Ontario, Canada, M5G 3S3 | |
| Principal Investigator: | Elizabeth Alvarez, MD | McMaster University | |
| Principal Investigator: | Arielle Sutton, MPH | McMaster University |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 22, 2019 | ||||||
| First Posted Date ICMJE | June 4, 2019 | ||||||
| Last Update Posted Date | April 8, 2021 | ||||||
| Estimated Study Start Date ICMJE | April 30, 2019 | ||||||
| Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Change from baseline each week until 9 weeks and at 8 months post-baseline ] 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).
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Evaluating a Group-based Therapeutic Yoga Program for Burnout | ||||||
| Official Title ICMJE | Evaluating a Group-based Therapeutic Yoga Program for Burnout | ||||||
| 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:
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. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment 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. Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: 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.
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| Study Arms ICMJE | Experimental: A primary care group-based therapeutic yoga program
A primary care care group-based therapeutic yoga program that consists of 9 sessions.
Intervention: Behavioral: A primary care group-based therapeutic yoga program
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Withdrawn | ||||||
| Actual Enrollment ICMJE |
0 | ||||||
| Original Estimated Enrollment ICMJE |
40 | ||||||
| Estimated Study Completion Date ICMJE | May 31, 2022 | ||||||
| Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Canada | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03973216 | ||||||
| Other Study ID Numbers ICMJE | Yoga MD for burnout | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Elizabeth Alvarez, McMaster University | ||||||
| Study Sponsor ICMJE | McMaster University | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | McMaster University | ||||||
| Verification Date | April 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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