A Comprehensive Group Intervention for Psychosocial Personnel at Risk of Stress and Moral Injury

Official title

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

Overview

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.

Detailed 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.

Interventions

• Behavioral CARE MI
  The intervention consists of four sessions, each lasting between 60 and 90 minutes, ideally delivered on consecutive weeks. It integrates psychoeducation on trauma and moral injury, emotional regulation strategies, and incorporates elements from several evidence-based approaches. These include the EMDR-IGTP-OTS group protocol, acceptance and values-based work from ACT, and self-compassion-focused interventions. In the Waiting List arm, CARE-MI will be delivered after the initial assessment peri
• Behavioral TAU: Treatment as usual
  During the waiting period, Waiting list group will receive usual institutional support.

Primary outcome measures

• Change in posttraumatic stress symptoms [Time frame: Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]
• Change in moral injury symptoms [Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]

Secondary outcome measures (8)

• Change in anxiety symptoms [Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Change in depressive symptoms [Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Change in mental wellbeing [Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Change in perceived meaning at work [Time frame: Time Frame: Baseline]
• Change in perceived ability to cope with trauma [Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Change in openness to the future [Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Change in experiential avoidance [Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Satisfaction with the intervention [Time frame: [Time Frame: Post-intervention (4 weeks)]]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Universidad Complutense — Madrid

Identifiers

NCT: NCT07140263 · CARE-MI-psychosocial personnel

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗