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临床试验/NCT06914843
NCT06914843已完成不适用

A Randomized Controlled Pilot of a Web-based Intervention for Cognitive Behavioral Therapy-based Training to Improve Mental Health in Medical Trainees

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年9月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Human Flourishing Index

研究概览

简要总结

This project aims to address stress, anxiety, burnout, and depression among medical trainees using a web-based intervention that teaches cognitive behavioral therapy (CBT)-based skills to increase resilience. The intervention is a web application ("OptimalWork", optimalwork.com) that includes a "MasterClass" consisting of about 20 interactive modules to be completed over four weeks (five days/week, 15-25 minutes/day). These modules teach principles and skills of CBT in an interactive manner and give tailored recommendations for how to apply and develop these skills in one's work and personal life. Participants who enroll in the study will be randomly assigned to either the MasterClass intervention or an active control (podcast listening) condition, and the control group will be given access to the MasterClass after 8 weeks. Measurements of well-being at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks will be compared between the groups as the primary outcome. Participant engagement as measured by MasterClass module completion and qualitative feedback will also be collected to guide future efforts at large-scale implementation in medical trainees and healthcare workers.

详细描述

Medical students face significant mental health challenges, with burnout being a prevalent concern. Given the efficacy of cognitive behavioral therapy (CBT) and mindfulness-based approaches for treating mood and anxiety disorders, many individual-level interventions to reduce stress or prevent burnout have focused on teaching people these psychological skills, including digital approaches that aim to overcome the barriers to implementation of face-to-face therapy.

One such digital intervention is OptimalWork (optimalwork.com), an online platform that teaches CBT- and mindfulness-based skills as they apply in daily life and work. The focus of the intervention is learning to reframe challenges in one's everyday work as opportunities to grow according to one's ideals and to strengthen one's bonds with others. Our primary aims are to determine the feasibility, acceptability, and preliminary effect size of this intervention in medical students. The Investigators also aim to describe relationships between different measures of well-being, including some that measure clinical symptoms and others that measure flourishing. Finally, the investigators aim to identify barriers and facilitators to successful implementation in this population through exit interviews and other qualitative feedback.

We are conducting a 16-week randomized controlled trial, comparing the OptimalWork online program versus a Podcast Listening control group (described below). Podcasts were chosen from RadioLab to last about the same time as the OptimalWork program (10-15 minutes / day, 5 days / week for 4 weeks) but with content unrelated to wellness or mental health. The intervention period lasts 4 weeks, and outcome measures (surveys) are administered at baseline, 4, 8, 12, and 16 weeks. After 8 weeks and completion of the second follow-up survey, participants are given the option to access the other intervention if they so desired. This is to ensure equity in access to the intervention between groups.

Eligible participants are students currently enrolled at Washington University School of Medicine from all class years (M1-M4, including those on research years and MD/PhD students in the PhD years). Participants must not be participating in another behavioral health or well-being intervention at the time of enrollment. The investigators are not excluding participants based on mental health diagnosis or active treatment.

All participants provide informed consent electronically after reviewing the nature, risks, and benefits of the study, under protocols approved by the Washington University Human Research Protection Office.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Participants are randomized using a digital data management platform (REDCap) and investigators and analysts remain blinded to participant identifiers.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Current or incoming WashU School of Medicine Student

排除标准

  • •Currently participating in another behavioral health / well-being intervention
  • •Unwilling or unable to provide informed consent

研究组 & 干预措施

OptimalWork

Experimental

An online intervention that teaches concepts of cognitive restructuring, mindfulness, and behavioral activation as they apply in one's daily life and work. Users are given personalized content recommendations based on their inventory results and instructed to complete 15-25 minutes of content per day, 5 days/week for 4 weeks.

干预措施: OptimalWork (Behavioral)

Podcast Listening

Active Comparator

A curated series of podcasts on topics unrelated to cognitive behavioral therapy or mindfulness, modeled after a similar control from a study of a mindfulness based intervention (Basso et al. 2019). Users are instructed to complete one podcast per day on a digital platform (~15 minutes/day), 5 days/week for 4 weeks.

干预措施: Podcast Listening (Behavioral)

结局指标

主要结局

Human Flourishing Index

时间窗: 8 weeks

Broad well-being based around 5 domains of happiness, mental and physical health, meaning and purpose, character and virtue, and close social relationships.

OptimalWork Inventory

时间窗: 8 weeks

24-item survey designed to measure how well one is engaging challenges in one's work and personal life

次要结局

  • Stress - BIPS(8 weeks)
  • Burnout and professional fulfillment(8 weeks)
  • Anxiety - PROMIS(8 weeks)
  • Depression - PROMIS(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ginger E Nicol

Associate Professor of Psychiatry (Child)

Washington University School of Medicine

研究点 (1)

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