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CARE-MI: A Comprehensive Group Intervention for Psychosocial Personnel at Risk of Experiencing Symptoms of Post-traumatic Stress and/or Moral Injury Associated With Work-related Stress: Design, Implementation, and Efficacy
The objective of this randomized controlled trial is to evaluate the effectiveness of the CARE-MI group intervention in reducing symptoms of post-traumatic stress and moral injury in support staff working with individuals diagnosed with physical or mental health conditions (psychosocial personnel). The study also seeks to assess its impact on symptoms of anxiety and depression, as well as its potential to improve overall well-being. We will conduct a multicomponent study involving several pre-existing teams from collaborating centers, allowing the intervention to be evaluated in different institutional settings. This is a multilevel randomized trial, with each group randomly assigned, through blinded allocation using a computer program, to either the intervention group or a wait-list control group. Participants will be assessed at three time points: pre-intervention, post-intervention, and at a 6-month. This trial is part of a larger research project that includes several related studies. Each study addresses a specific population and/or intervention, but all share the overarching aim of Coping and adaptation for recovery from moral injury.
There is growing evidence of high prevalence rates of emotional distress, including PTSD, anxiety, depression, and moral injury, among healthcare professionals, particularly those exposed to high emotional loads or critical care settings. Studies report PTSD rates ranging from 10% to 20%, and up to 30% in ICU staff. These figures increase significantly during large-scale crises such as pandemics. For instance, during the COVID-19 outbreak, rates of PTSD symptoms reached up to 54% among U.S. healthcare workers, along with 48% for depression and 30% for anxiety. Similar findings were observed in Spain and China, with high moral injury prevalence associated with anxiety and depression symptoms. Moral injury is particularly concerning in settings with staffing shortages, where professionals feel unable to provide adequate care. This scenario extends to the mental health support network, including social and psychological care teams. In Spain, significant rates of emotional exposure (36%) and workplace violence have been reported among technical and support staff. Although trauma-focused interventions have shown efficacy in treating PTSD, most evidence focuses on individual formats. Group interventions, however, offer a scalable, resource-efficient alternative, with promising outcomes reported for ACT, mindfulness, EMDR, and other trauma-informed approaches. Despite this evidence, few interventions are specifically adapted and evaluated for mental health and healthcare professionals in their specific work contexts. This trial addresses this gap by evaluating the CARE-MI protocol in real-world care settings.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Universidad Complutense
Madrid, Madrid, Spain
Start Date
February 10, 2025
Primary Completion Date
June 30, 2026
Completion Date
December 31, 2026
Last Updated
January 21, 2026
92
ESTIMATED participants
CARE MI
BEHAVIORAL
TAU: Treatment as usual
BEHAVIORAL
Lead Sponsor
Universidad Complutense de Madrid
NCT06230887
NCT05020587
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05550753