Intervention Trial for Healthcare Workers With Anxiety

NCT06460285 | Active Not Recruiting

• 1 other identifier: IRB#23-001651
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Keywords

anxiety; stress; emotion regulation

Outcome Measures

Primary Outcomes (2)

• EmRes Efficacy - anxiety change at follow-up 1

  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.

  Baseline to Follow-up 1 (9 weeks)

• EmRes Efficacy - anxiety change at follow-up 2

  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.

  Baseline to Follow-up 2 (18 weeks)

Secondary Outcomes (4)

• Perceived stress change at follow-up 1

  Baseline to Follow-up 1 (9 weeks)

• Perceived stress change at follow-up 2

  Baseline to Follow-up 2 (18 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)

Study Arms (2)

Mindfulness

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness

EmRes

EXPERIMENTAL

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.

Behavioral: EmRes

Interventions

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.

EmRes

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.

Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (4)

• 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.

  PMID: 18835479 BACKGROUND

• 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.

  PMID: 29388896 BACKGROUND

• 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.

  PMID: 34858231 BACKGROUND

• 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.

  PMID: 27499606 BACKGROUND

Related Links

• California Health Care Foundation

MeSH Terms

Conditions

Anxiety Disorders; Emotional Regulation

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be unaware of what group they are in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: October 29, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)