Depression Clinical Trial
Official title:
Improving the Mental Health of Resident Physicians and Fellows : Reducing Burnout & Enhancing Resilience Through Transcendental Meditation
NCT number | NCT04586309 |
Other study ID # | 2008969193 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2021 |
Est. completion date | December 2021 |
Verified date | September 2021 |
Source | University of Arizona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This proposal aims to optimize resident physician and fellow wellness and performance at Banner University Medical Center through an evidence-based stress reduction program, Transcendental Meditation (TM). It is particularly timely due to the enormous pressure and stress that residents face as front-line workers during the current 2019 novel coronavirus (COVID-19) pandemic. Participants will be randomly assigned to the TM training (group 1), or delayed TM training (group 2). Study outcomes will be assessed at baseline and at 1 and 3 months post-training. Participants who are assigned to group 2 , will receive the TM training following the three month assessment, and then complete assessments at 1 and 3 months post-training. These assessment tools look at anxiety (Generalized Anxiety Disorder Scale-GAD-7), depression (Patient Health Questionnaire (PHQ-9), insomnia (Pittsburgh Sleep Quality Index PSQI), psychological distress (Brief Symptom Inventory BSI18), burnout (Maslach Burnout Inventory-MBI), resilience (Conner-Davidson Resilience Scale- RISC), and alcohol use (Alcohol Use Disorder Identification Test - AUDIT).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Full-time Resident physicians or Fellows employed by Banner Health 2. 18 years or older 3. Some participants included will have treated COVID-19 patients or be working at locations where COVID-19 patients are being treated. 4. Willing to take part in either group assignment (randomized to either immediate start or TM training, or delayed TM training) 5. Willing to complete baseline, 1-month and 3-month post- assessments 6. If being treated with psychoactive medications, the maintenance of a stable regimen for at least two months before enrollment (by self-report). Exclusion Criteria: 1. Already instructed in the Transcendental Meditation technique 2. Currently unstable psychotic symptoms, mania or bipolar disorder as demonstrated by self-report, or psychiatric hospitalizations in the past six months; 3. Current suicidal or homicidal ideation with intent or plan. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Arizona | David Lynch Foundation |
Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976. — View Citation
Valosek L, Link J, Mills P, Konrad A, Rainforth M, Nidich S. Effect of Meditation on Emotional Intelligence and Perceived Stress in the Workplace: A Randomized Controlled Study. Perm J. 2018;22:17-172. Published 2018 Oct 29. doi:10.7812/TPP/17-172
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Burnout | Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout. | baseline | |
Primary | Burnout | Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout. | 1 month | |
Primary | Burnout | Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout. | 3 month | |
Secondary | Resilience | Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience. | baseline | |
Secondary | Resilience | Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience. | 1 month | |
Secondary | Resilience | Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience. | 3 months | |
Secondary | Alcohol use | AUDIT: Alcohol Use Disorders Identification Test- Participants respond to 10 items with 0-4, higher score more concerning for alcohol use disorder. | baseline | |
Secondary | Alcohol use | AUDIT: Alcohol Use Disorders Identification Test- Participants respond to 10 items with 0-4, higher score more concerning for alcohol use disorder. | 1 month | |
Secondary | Alcohol use | AUDIT: Alcohol Use Disorders Identification Test- Participants respond to 10 items with 0-4, higher score more concerning for alcohol use disorder. | 3 months | |
Secondary | Depression | PHQ-9: Patient Health Questionnaire- Participants answer each prompt (not all all, some days, most days, nearly every day) higher numbers indicate greater depressive symptoms. | baseline | |
Secondary | Depression | PHQ-9: Patient Health Questionnaire- Participants answer each prompt (not all all, some days, most days, nearly every day) higher numbers indicate greater depressive symptoms. | 1 month | |
Secondary | Depression | PHQ-9: Patient Health Questionnaire- Participants answer each prompt (not all all, some days, most days, nearly every day) higher numbers indicate greater depressive symptoms. | 3 months | |
Secondary | Sleep Quality | PSQI: Pittsburgh Sleep Quality Index- Participant answers 19 questions in 7 sections, Seven sections are combined for global score of 0-21 where ) is no problems and 21 is problems in all areas. | baseline | |
Secondary | Sleep Quality | PSQI: Pittsburgh Sleep Quality Index- Participant answers 19 questions in 7 sections, Seven sections are combined for global score of 0-21 where ) is no problems and 21 is problems in all areas. | 1 month | |
Secondary | Sleep Quality | PSQI: Pittsburgh Sleep Quality Index- Participant answers 19 questions in 7 sections, Seven sections are combined for global score of 0-21 where ) is no problems and 21 is problems in all areas. | 3 months | |
Secondary | Distress | BSI18: Brief Symptom Inventory 18- Participants answer 18 questions on 0-4 scale. Higher numbers indicate more distress. | baseline | |
Secondary | Distress | BSI18: Brief Symptom Inventory 18 | 1 month | |
Secondary | Distress | BSI18: Brief Symptom Inventory 18 | 3 months | |
Secondary | Anxiety | GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety, | baseline | |
Secondary | Anxiety | GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety, | 1 month | |
Secondary | Anxiety | GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety, | 3 months |
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