Moral InjuryCARE-MI-PsychSNCT07140263
A Comprehensive Group Intervention for Psychosocial Personnel at Risk of Stress and Moral Injury
A study testing CARE MI and TAU: Treatment as usual in people with Moral Injury and TEPT, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moral Injury, TEPT
- What is being tested?
- CARE MI and TAU: Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2025to 30 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None explicitly defined
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Moral Injury, TEPT
- Being tested
- CARE MI, TAU: Treatment as usual
- Keywords
- psychosocial personnel, moral injury intervention, CARE-MI
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARE MIBehavioural
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 usualBehavioural
During the waiting period, Waiting list group will receive usual institutional support.
| Study group | Role | What they receive |
|---|---|---|
| CARE MI | Experimental | 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. Receives: Behavioral: CARE MI |
| Waiting list (Delayed CARE-MI) | Other | 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. Receives: Behavioral: CARE MI; Behavioral: TAU: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in posttraumatic stress symptoms
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).
Measured: Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up
Change in moral injury symptoms
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).
Measured: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]
Secondary outcomes (8)
Change in anxiety symptoms
Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer et al., 2006). Higher scores indicate greater anxiety (minimum and maximun values: 0 and 21).
Measured: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]
Change in depressive symptoms
Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). Higher scores indicate greater depressive symptoms (minimum and maximun values: 0 and 27).
Measured: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]
Change in mental wellbeing
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS; Tennant et al., 2007). Higher scores indicate better wellbeing (minimum and maximun values: 14 and 70)..
Measured: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]
Change in perceived meaning at work
Work and Meaning Inventory (WAMI; Steger, 2012). Higher scores indicate greater perceived meaning (minimum and maximun values: 10 and 50).
Measured: Time Frame: Baseline
Change in perceived ability to cope with trauma
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).
Measured: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]
Change in openness to the future
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).
Measured: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]
Change in experiential avoidance
Brief Experiential Avoidance Questionnaire (BEAQ; Gámez et al., 2014). Higher scores indicate greater experiential avoidance (minimum and maximun values: 15 and 90).
Measured: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]
Satisfaction with the intervention
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).
Measured: [Time Frame: Post-intervention (4 weeks)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start10 Feb 2025
- Primary completion30 Jul 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moral InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multilevel randomized trial, in which preexisting work teams (group levels) are randomly assigned to either the CARE-MI intervention or a waitlist control group. Assessments are conducted at baseline, post-intervention, and at the 6-month follow-up.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Regina Espinosa, Full Porfessor, Principal investigator, Camilo Jose Cela UniversityCarmen Valiente, Full Porfessor, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140263
- Sponsor's protocol ID
- CARE-MI-psychosocial personnel
- Acronym
- CARE-MI-PsychS
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code