Intervention Trial for Healthcare Workers With Anxiety

NCT ID: NCT06460285

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-29

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Due to the objectives and nature of the study, the identity of test and control treatments will be known to investigators and research staff. Participants will, however, be blind to their conditional assignment. The active control condition was carefully selected to ensure that participants would be unaware if they were in the experimental or control condition, similar to using a taste-matching agent in a drug trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The participants will be unaware of what group they are in.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Mindfulness

Intervention Type 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.

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.

Group Type EXPERIMENTAL

EmRes

Intervention Type 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.

Interventions

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EmRes

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Must be able to provide written informed consent
2. \> 18 years of age at Visit
3. Fluent in English
4. Current healthcare worker in a hospital
5. Generalized anxiety disorder (GAD) score of \> 5

Exclusion Criteria

1. Unable to provide written informed consent
2. Under the age of 18
3. Not fluent in English
4. Not working as a healthcare worker in a hospital
5. GAD score \< 5
6. Currently on anxiety medication (Beta Blockers or Benzodiazepines)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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George M. Slavich, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Summer Mengelkoch, PhD

Role: CONTACT

7632322908

Katie Firestone, BA

Role: CONTACT

(310) 220-0388

Facility Contacts

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Katie Firestone

Role: primary

310-220-0388

References

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Berking M, Wupperman P, Reichardt A, Pejic T, Dippel A, Znoj H. Emotion-regulation skills as a treatment target in psychotherapy. Behav Res Ther. 2008 Nov;46(11):1230-7. doi: 10.1016/j.brat.2008.08.005. Epub 2008 Aug 30.

Reference Type BACKGROUND
PMID: 18835479 (View on PubMed)

Schnell K, Herpertz SC. Emotion Regulation and Social Cognition as Functional Targets of Mechanism-Based Psychotherapy in Major Depression With Comorbid Personality Pathology. J Pers Disord. 2018 Jan;32(Suppl):12-35. doi: 10.1521/pedi.2018.32.supp.12.

Reference Type BACKGROUND
PMID: 29388896 (View on PubMed)

Ghahramani S, Lankarani KB, Yousefi M, Heydari K, Shahabi S, Azmand S. A Systematic Review and Meta-Analysis of Burnout Among Healthcare Workers During COVID-19. Front Psychiatry. 2021 Nov 10;12:758849. doi: 10.3389/fpsyt.2021.758849. eCollection 2021.

Reference Type BACKGROUND
PMID: 34858231 (View on PubMed)

Fresco DM, Mennin DS, Heimberg RG, Ritter M. Emotion Regulation Therapy for Generalized Anxiety Disorder. Cogn Behav Pract. 2013 Aug;20(3):282-300. doi: 10.1016/j.cbpra.2013.02.001.

Reference Type BACKGROUND
PMID: 27499606 (View on PubMed)

Related Links

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https://www.chcf.org/

California Health Care Foundation

Other Identifiers

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IRB#23-001651

Identifier Type: -

Identifier Source: org_study_id

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