A Comprehensive Group Intervention for Psychosocial Personnel at Risk of Stress and Moral Injury (CARE-MI-PsychS)

Universidad Complutense de Madrid

Status: Invitation-only

Conditions: Moral Injury; TEPT

Treatments: Behavioral: TAU: Treatment as usual; Behavioral: CARE MI

Study type: Interventional

Funder types: Other

Identifiers

NCT07140263

CARE-MI-psychosocial personnel

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 or older
• Be currently employed as healthcare or support staff at the time of the intervention
• Provide informed consent
• Be fluent in Spanish

Exclusion criteria

- None explicitly defined

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

CARE MI

Experimental group

Description:

CARE-MI is a trauma-informed integrative group intervention designed to reduce post-traumatic stress symptoms and moral injury in psychosocial personnel working with individuals with physical or mental health conditions.

Treatment:

Behavioral: CARE MI

Waiting list (Delayed CARE-MI)

Other group

Description:

Participants assigned to the waiting list will receive the CARE-MI intervention after the experimental group completes the initial study period. During the waiting period, they will receive usual institutional support. This design allows for comparison between groups while ensuring that all participants eventually receive the CARE-MI program.

Treatment:

Behavioral: CARE MI

Behavioral: TAU: Treatment as usual