Clinical trial NCT06460285: Intervention Trial for Healthcare Workers With Anxiety
Official title: CalmER Intervention Trial for Healthcare Workers With Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: anxiety
stress
emotion regulation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: EmRes Efficacy - anxiety change at follow-up 1
timeFrame: Baseline to Follow-up 1 (9 weeks)
measure: EmRes Efficacy - anxiety change at follow-up 2
timeFrame: Baseline to Follow-up 2 (18 weeks)
Secondary outcomes:
measure: Perceived stress change at follow-up 1
timeFrame: Baseline to Follow-up 1 (9 weeks)
measure: Perceived stress change at follow-up 2
timeFrame: Baseline to Follow-up 2 (18 weeks)
measure: Burnout change at follow-up 1
timeFrame: Baseline to Follow-up 1 (9 weeks)
measure: Burnout change at follow-up 2
timeFrame: Baseline to Follow-up 2 (18 weeks)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.