Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06460285

Intervention Trial for Healthcare Workers With Anxiety

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Behavior Emotional Regulation Mental Disorders Self-Control Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

EmRes

Behavioral

There will be six, one hour, treatment sessions across nine weeks of emotional resolution therapy, a post treatment assessment, and a follow up assessment three months later. The sessions will occur over zoom with a licensed therapist.

Mindfulness

Behavioral

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.

Primary outcomes

  1. EmRes Efficacy - anxiety change at follow-up 1

    Time frame: 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.

  2. EmRes Efficacy - anxiety change at follow-up 2

    Time frame: 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.

Secondary outcomes

  1. Perceived stress change at follow-up 1

    Time frame: Baseline to Follow-up 1 (9 weeks)

    The Perceived Stress Scale (PSS) is used to measure the perception of stress. That is, the degree to which situations in one's life are appraised as stressful.

    PSS scores are computed by summing ten items. Items 4, 5, 7, and 8 are reverse-scored. The range of the PSS-10 is 0-40, with higher scores indicating more perceived stress. As such, a statistically significant decrease in PSS-10 scores from baseline to follow-up one indicates decreased stress and is a positive outcome.

  2. Perceived stress change at follow-up 2

    Time frame: Baseline to Follow-up 2 (18 weeks)

    The Perceived Stress Scale (PSS) is used to measure the perception of stress. That is, the degree to which situations in one's life are appraised as stressful.

    PSS scores are computed by summing ten items. Items 4, 5, 7, and 8 are reverse-scored. The range of the PSS-10 is 0-40, with higher scores indicating more perceived stress. As such, a statistically significant decrease in PSS-10 scores from baseline to follow-up two indicates decreased stress and is a positive outcome.

  3. Burnout change at follow-up 1

    Time frame: Baseline to Follow-up 1 (9 weeks)

    Burnout will be measured by The Maslach Burnout Inventory (MBI) which contains 22 symptom items pertaining to occupational burnout. Investigators will sum the first two sections (where higher scores represent a negative outcome) and balance this against the third section (where higher scores represent a positive outcome). Scores will be calculated as a ratio: Exhaustion+Depersonalization:Personal Achievement. High ratios reflect more burnout, and low ratios reflect less burnout. A statistically significant reduction in burnout from baseline to follow-up 1 represents a positive outcome.

    Exhaustion: 6 items, scores are summed, with a range of 0-36 possible. Higher scores = more exhaustion/burnout Depersonalization: 7 items, scores are summed, with a range of 0-42 possible. Higher scores = more depersonalization/burnout Personal achievement: 8 items, scores are summed, with a range of 0-48 possible. Higher scores = more personal achievement/less burnout

  4. Burnout change at follow-up 2

    Time frame: Baseline to Follow-up 2 (18 weeks)

    Burnout will be measured by The Maslach Burnout Inventory (MBI) which contains 22 symptom items pertaining to occupational burnout. Investigators will sum the first two sections (where higher scores represent a negative outcome) and balance this against the third section (where higher scores represent a positive outcome) . Scores will be calculated as a ratio: Exhaustion+Depersonalization:Personal Achievement. High ratios reflect more burnout, and low ratios reflect less burnout. A statistically significant reduction in burnout from baseline to follow-up 2 represents a positive outcome.

    Exhaustion: 6 items, scores are summed, with a range of 0-36 possible. Higher scores = more exhaustion/burnout Depersonalization: 7 items, scores are summed, with a range of 0-42 possible. Higher scores = more depersonalization/burnout Personal achievement: eight items, scores are summed, with a range of 0-48 possible. Higher scores = more personal achievement/less burnout

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

CalmER Intervention Trial for Healthcare Workers With Anxiety

Acronym: CalmER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 14, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.