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临床试验/NCT04586309
NCT04586309撤回不适用

Improving the Mental Health of Resident Physicians and Fellows : Reducing Burnout & Enhancing Resilience Through Transcendental Meditation

University of Arizona0 个研究点开始时间: 2021年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Burnout

研究概览

简要总结

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).

详细描述

Up to one hundred resident and fellow physicians employed by Banner Health will participate in the project. Participants will be randomly assigned to either the TM program or to a delayed TM training, treatment-as-usual control group . Study outcomes will be assessed at baseline, 1-month and 3-month post-training , with change in burnout as the primary outcome. Control subjects (aka delayed TM training or Group 2) will be eligible to learn TM after completing 3 month post-testing. Group 2 will also complete post-training assessments at 1-month and 3-months post-training. The total duration of this project will be 60 months.

Two experienced certified TM instructors will conduct the instruction. All certified TM teachers have been extensively trained in the teaching of the TM program, including teaching the course of instruction, verifying continued correctness of effortless practice of the technique, and conducting additional follow-up sessions. The same standardized TM course sequence will be used for all study participants.

Outline of Transcendental Meditation Program: TM group will involve 10 total sessions over 12 weeks (about 75 minutes per session). The core instruction in the TM technique will involve a course of instruction, taught over five sessions. The five core instruction sessions will include:

  1. 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(75 minutes- group session); After the introductory session, a Personal Interview is conducted telephonically-with a teacher of the TM program. The participant completes a brief interview form prior to the call. The interviewer (a teacher with the TM program) reviews the form with the participant.

The four classes of TM instruction adhere to a standardized teaching protocol and are conducted by certified teachers of the Transcendental Meditation program trained and approved by the Transcendental Meditation organization. 2. Personal Instruction-individual one-on-one instruction in the TM technique (75 minutes). The student learns the mechanics of the TM technique. At the conclusion of this class the student is able to meditate properly. 3. First Day of Verification of Correct Practice and Further Instruction (90 minutes-group session); The first follow-up session provides information to help students incorporate TM into their daily life. 4. Second Day of Verification of Correct Practice-understanding the mechanics of the TM technique from personal experiences (90 minutes-group session); The second session provides information about how the meditation reduces stress and improves health 5. Third Day of Verification of Correct Practice-understanding the mechanics of the development of higher human potential and wellness (90 minutes-group session). The third session reviews students' experiences both during and after meditation, and provides further instruction to support their ongoing home practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Full-time Resident physicians or Fellows employed by Banner Health
  • 18 years or older
  • Some participants included will have treated COVID-19 patients or be working at locations where COVID-19 patients are being treated.
  • Willing to take part in either group assignment (randomized to either immediate start or TM training, or delayed TM training)
  • Willing to complete baseline, 1-month and 3-month post- assessments
  • If being treated with psychoactive medications, the maintenance of a stable regimen for at least two months before enrollment (by self-report).

排除标准

  • Already instructed in the Transcendental Meditation technique
  • Currently unstable psychotic symptoms, mania or bipolar disorder as demonstrated by self-report, or psychiatric hospitalizations in the past six months;
  • Current suicidal or homicidal ideation with intent or plan.

结局指标

主要结局

Burnout

时间窗: 3 month

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.

次要结局

  • Distress(3 months)
  • Resilience(3 months)
  • Alcohol use(3 months)
  • Anxiety(3 months)
  • Depression(3 months)
  • Sleep Quality(3 months)

研究者

申办方类型
Other
责任方
Sponsor

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