CalmER Intervention Trial for Healthcare Workers With Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- EmRes Efficacy - anxiety change at follow-up 1
研究概览
简要总结
The purpose of the study is to conduct an initial test of the efficacy of Emotional Resolution (EmRes) therapy to reduce anxiety in healthcare workers. The investigators hypothesize EmRes will reduce levels of anxiety in participants compared to an active control group engaged in mindfulness-based gratitude.
详细描述
More than 1 in 5 adults in the US live with a mental illness, however, treatment is inaccessible to many. In fact, 63% of Californians with a mental health disorder do not receive treatment. Those who do receive treatment are burdened with long wait times. For example, the National Council of Mental Wellbeing reports the average wait time to access behavioral health services is currently about six weeks. Health care workers have been particularly affected by the inaccessibility of mental health treatment options, with nearly half of healthcare workers experiencing burnout during the COVID-19 pandemic. Therefore it is important to explore new types of effective and accessible therapeutic techniques.
Many different therapeutic techniques are emerging that may expand the toolkit of mental healthcare providers to allow them to deliver new solutions to their patients. For example, therapeutic programs which target emotion regulation have been found to increase the efficacy of more traditional psychotherapy. Here, the investigators seek to test the efficacy of one such therapeutic technique, Emotional Resolution therapy, at reducing anxiety in healthcare workers. Because this therapeutic technique is delivered via zoom, and typically consists of only 6-8 sessions, it offers a promising solution to those seeking treatment in a more accessible and less burdensome way. If effective at reducing anxiety in healthcare workers, this therapeutic technique may reduce the burden on mental healthcare providers and help deal with the mental health crisis that is causing healthcare workers to quit due to burnout and burdening our society.
The investigators will recruit healthcare workers with anxiety to participate in the study who will be randomly assigned to complete either the target therapeutic or control intervention. Participants will be asked to participate in a baseline assessment and six one-hour treatment sessions across 9 weeks, a post treatment assessment, and a follow up assessment three months later. The investigators will collect micro blood samples and will provide a smart watch as compensation for their participation, which they will ask participants to wear throughout the duration of the study. Participants do not need to come into the lab to participate. All research activities will occur online, and devices and samples will be mailed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participants will be unaware of what group they are in.
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
- •Must be able to provide written informed consent
- •> 18 years of age at Visit
- •Fluent in English
- •Current healthcare worker in a hospital
- •Generalized anxiety disorder (GAD) score of > 5
排除标准
- •Unable to provide written informed consent
- •Under the age of 18
- •Not fluent in English
- •Not working as a healthcare worker in a hospital
- •GAD score < 5
- •Currently on anxiety medication (Beta Blockers or Benzodiazepines)
研究组 & 干预措施
Mindfulness
There will be six, one hour, treatment sessions across nine weeks of a mindfulness intervention program, a post treatment assessment, and a follow up assessment three months later. The sessions will occur over zoom with a trained member of the study staff.
干预措施: Mindfulness (Behavioral)
EmRes
There will be six, one hour, treatment sessions across nine weeks of an Emotional Resolution therapy intervention program, a post treatment assessment, and a follow up assessment three months later. The sessions will occur over zoom with a trained emotional resolution coach.
干预措施: EmRes (Behavioral)
结局指标
主要结局
EmRes Efficacy - anxiety change at follow-up 1
时间窗: Baseline to Follow-up 1 (9 weeks)
The purpose of the study is to conduct an initial test of the efficacy of EmRes therapy to change anxiety levels in healthcare workers. The investigators hypothesize EmRes will change levels of anxiety from baseline to follow-up 1 in participants compared to an active control group engaged in mindfulness-based gratitude. This will be measured by the 8 item PROMIS Anxiety Short form. Responses to each item are summed. Scores range from 8-40, with a higher score indicating higher anxiety. A statistically significant decrease from baseline to follow-up one in anxiety scores is a positive outcome.
EmRes Efficacy - anxiety change at follow-up 2
时间窗: Baseline to Follow-up 2 (18 weeks)
The purpose of the study is to conduct an initial test of the efficacy of EmRes therapy to change in healthcare workers. The investigators hypothesize EmRes will change levels of anxiety from baseline to follow-up 2 in participants compared to an active control group engaged in mindfulness-based gratitude. This will be measured by the 8 item PROMIS Anxiety Short form. Responses to each item are summed. Scores range from 8-40, with a higher score indicating higher anxiety. A statistically significant decrease from baseline to follow-up two in anxiety scores is a positive outcome.
次要结局
- Perceived stress change at follow-up 2(Baseline to Follow-up 2 (18 weeks))
- Perceived stress change at follow-up 1(Baseline to Follow-up 1 (9 weeks))
- Burnout change at follow-up 1(Baseline to Follow-up 1 (9 weeks))
- Burnout change at follow-up 2(Baseline to Follow-up 2 (18 weeks))
研究者
George M. Slavich, PhD
Professor
University of California, Los Angeles