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
- Are there results?
- None posted in the registry
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.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07140263
- Acronym / sponsor ID
- CARE-MI-PsychS / CARE-MI-psychosocial personnel
- Conditions
- Moral Injury, TEPT
- Keywords
- psychosocial personnel, moral injury intervention, CARE-MI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CARE MI | Experimental | Behavioral: CARE MICARE-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. |
| Waiting list (Delayed CARE-MI) | Other | Behavioral: CARE MI, Behavioral: TAU: Treatment as usualParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None explicitly defined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARE MIThe 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. | Behavioural | CARE MI, Waiting list (Delayed CARE-MI) |
| TAU: Treatment as usualDuring the waiting period, Waiting list group will receive usual institutional support. | Behavioural | Waiting list (Delayed CARE-MI) |
Primary outcome
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).
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).
8 secondary outcomes
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)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Espinosa, Full Porfessor principal investigator
Camilo Jose Cela University
Carmen Valiente, Full Porfessor principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in posttraumatic stress symptoms (time frame: Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.