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Enrolling by Invitation

NCT Number: NCT07140263

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

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.

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Key information

Conditions

Moral Injury Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic TEPT Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Complutense

Madrid, 28223, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CARE MI

Behavioral

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 period of the Experimental arm.

TAU: Treatment as usual

Behavioral

During the waiting period, Waiting list group will receive usual institutional support.

Primary outcomes

  1. Change in posttraumatic stress symptoms

    Time frame: Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up

    Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Blevins et al., 2015). Higher scores indicate greater PTSD symptoms (minimum and maximun values: 0 and 80).

  2. Change in moral injury symptoms

    Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

    Healthcare Moral Injury Scale (HMIS; Fradley et al., under review). Higher scores indicate higher levels of moral injury (minimum and maximun values: 5 and 50).

Secondary outcomes

  1. Change in anxiety symptoms

    Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

    Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer et al., 2006). Higher scores indicate greater anxiety (minimum and maximun values: 0 and 21).

  2. Change in depressive symptoms

    Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

    Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). Higher scores indicate greater depressive symptoms (minimum and maximun values: 0 and 27).

  3. Change in mental wellbeing

    Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

    Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS; Tennant et al., 2007). Higher scores indicate better wellbeing (minimum and maximun values: 14 and 70)..

  4. Change in perceived meaning at work

    Time frame: Time Frame: Baseline

    Work and Meaning Inventory (WAMI; Steger, 2012). Higher scores indicate greater perceived meaning (minimum and maximun values: 10 and 50).

  5. Change in perceived ability to cope with trauma

    Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

    Perceived Ability to Cope with Trauma Scale (PACT; Bonanno et al., 2011). Higher scores indicate greater coping flexibility (minimum and maximun values: 20 and 140).

  6. Change in openness to the future

    Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

    Openness to the Future Scale (OFS; Botella et al., 2018). Higher scores indicate greater positive affective orientation toward the future (minimum and maximun values: 10 and 50).

  7. Change in experiential avoidance

    Time frame: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

    Brief Experiential Avoidance Questionnaire (BEAQ; Gámez et al., 2014). Higher scores indicate greater experiential avoidance (minimum and maximun values: 15 and 90).

  8. Satisfaction with the intervention

    Time frame: [Time Frame: Post-intervention (4 weeks)]

    Client Satisfaction Questionnaire-8 (CSQ-8; Larsen et al., 1979). Higher scores indicate greater satisfaction with the intervention (minimum and maximun values: 4 and 32).

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study 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

Acronym: CARE-MI-PsychS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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