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Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date September 2021
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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Study Design


Intervention

Behavioral:
Transcendental meditation
Instruction in the TM technique is taught over five sessions. Introductory session-Review of previous scientific research on the TM program and a vision of possible benefits; Preparation- discussion of the mechanics and origin of the TM technique After the introductory session, a Personal Interview is conducted telephonically-with a teacher of the TM program. Personal Instruction-individual one-on-one instruction in the TM technique. The student learns the mechanics of the TM technique. At the conclusion of this class the student is able to meditate properly. First Day of Verification of Correct Practice and Further Instruction. Second Day of Verification of Correct Practice-understanding the mechanics of the TM technique from personal experiences. Third Day of Verification of Correct Practice-understanding the mechanics of the development of higher human potential and wellness.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Arizona David Lynch Foundation

References & Publications (2)

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

Outcome

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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