AnxietyCalmERNCT06460285
Intervention Trial for Healthcare Workers With Anxiety
A study testing EmRes and Mindfulness in people with Anxiety, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- EmRes and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: CalmER 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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- EmRes, Mindfulness
- Keywords
- anxiety, stress, emotion regulation
- Medical subject headings
- Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmResBehavioural
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.
MindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: EmRes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Follow-up 2 (18 weeks)
Secondary outcomes (4)
Perceived stress change at follow-up 1
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.
Measured: Baseline to Follow-up 1 (9 weeks)
Perceived stress change at follow-up 2
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.
Measured: Baseline to Follow-up 2 (18 weeks)
Burnout change at follow-up 1
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
Measured: Baseline to Follow-up 1 (9 weeks)
Burnout change at follow-up 2
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
Measured: Baseline to Follow-up 2 (18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start29 Oct 2024
- Primary completion25 May 2026
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George M. Slavich, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460285
- Sponsor's protocol ID
- IRB#23-001651
- Acronym
- CalmER
- Status last verified
- Feb 2026
- First submitted
- 10 Jun 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18835479Schnell 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.
PubMed 29388896Ghahramani 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.
PubMed 34858231Fresco 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.
PubMed 27499606
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CalmER Intervention Trial for Healthcare Workers With Anxiety
- ClinicalTrials.gov ID
- NCT06460285
- Acronym / sponsor ID
- CalmER / IRB#23-001651
- Conditions
- Anxiety
- Keywords
- anxiety, stress, emotion regulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Active comparator | Behavioral: MindfulnessThere 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 | Experimental | Behavioral: EmResThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmResThere 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. | Behavioural | EmRes |
| MindfulnessThere 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. | Behavioural | Mindfulness |
Primary outcome
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.
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.
4 secondary outcomes
Perceived stress change at follow-up 1
Time frame: Baseline to Follow-up 1 (9 weeks)
Perceived stress change at follow-up 2
Time frame: Baseline to Follow-up 2 (18 weeks)
Burnout change at follow-up 1
Time frame: Baseline to Follow-up 1 (9 weeks)
Burnout change at follow-up 2
Time frame: Baseline to Follow-up 2 (18 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 18835479Berking 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.
- Background: PubMed 29388896Schnell 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.
- Background: PubMed 34858231Ghahramani 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.
- Background: PubMed 27499606Fresco 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.
- California Health Care FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmRes and Mindfulness in people with Anxiety, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EmRes Efficacy - anxiety change at follow-up 1 (time frame: Baseline to Follow-up 1 (9 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460285, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.