Intervention Trial for Healthcare Workers With Anxiety
NCT Number: NCT06460285
Acronym: CalmER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety
Interventions: BEHAVIORAL: EmRes|BEHAVIORAL: Mindfulness
Sponsor: University of California, Los Angeles
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-21
Completion Date: 2025-03-21

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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., 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, 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, Baseline to Follow-up 2 (18 weeks)