Moral DistressCARE-MINCT07887581
Coping and Adaptation for Recovery From Moral Injury: A Group Intervention for Clinical Psychology Residents
A study testing CARE-MI Group Intervention in people with Moral Distress and Moral Injury, run by Universidad Complutense de Madrid.
Trial summary
Moral distress may arise when health care professionals are unable to act in accordance with their professional values or believe that they have participated in, witnessed, or been unable to prevent situations that conflict with those values. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moral Distress, Moral Injury
- What is being tested?
- CARE-MI Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18 years or older.
- Currently undertaking specialized postgraduate training as a clinical psychology resident in Spain.
- Able to understand written and spoken Spanish.
- Willing and able to attend the CARE-MI group sessions and complete the study assessments.
- Able to provide informed consent.
Who cannot join
- Not currently undertaking specialized postgraduate training as a clinical psychology resident.
- Inability to understand the study information or provide informed consent.
- Insufficient command of Spanish to participate in the group intervention or complete the assessments.
- Any acute psychological or psychiatric condition that, in the judgment of the research team, requires immediate or more intensive clinical care and would make participation in the group intervention inappropriate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Carmen Valiente Ots, PhD contact
About this study
Official title: Feasibility and Preliminary Effects of Coping and Adaptation for Recovery From Moral Injury (CARE-MI), a Group Intervention for Clinical Psychology Residents: A Single-Group Pre-Post Pilot Study
Moral distress may arise when health care professionals are unable to act in accordance with their professional values or believe that they have participated in, witnessed, or been unable to prevent situations that conflict with those values. Repeated or particularly difficult experiences may affect emotional well-being, professional identity, and the meaning associated with clinical work.
This single-group pilot study will evaluate the feasibility, acceptability, and preliminary effects of Coping and Adaptation for Recovery from Moral Injury (CARE-MI), a four-session group intervention for clinical psychology residents in Spain. Each 90-minute session addresses one of four components: moral awareness, emotional flexibility, moral repair, and professional flourishing. The program is designed to help participants recognize morally difficult experiences, respond more flexibly to associated thoughts and emotions, review responsibility in a fair and contextualized way, and protect the values and resources needed for professional practice.
Participants will complete assessments before and after the intervention. Changes in moral distress and psychological well-being will be examined, together with indicators of intervention feasibility and acceptability.
Read the detailed description
Clinical psychology residents may encounter situations in which clinical responsibilities, patient needs, institutional constraints, supervisory decisions, or limitations in available resources conflict with deeply held professional values. These experiences can generate moral distress and may be accompanied by guilt, shame, anger, helplessness, self-criticism, reduced professional confidence, or loss of meaning in clinical work. Residents may be particularly vulnerable because they combine direct clinical responsibility with a professional role that is still developing and with dependence on supervision and organizational structures.
Coping and Adaptation for Recovery from Moral Injury (CARE-MI) is a manualized, group-based intervention designed to prevent and address the psychological impact of morally difficult professional experiences. The intervention has been adapted for clinical psychology residents, taking into account their previous psychological knowledge, their role as therapists in training, and challenges related to supervision, therapeutic responsibility, professional identity, and institutional limitations.
The program consists of four 90-minute group sessions. The first session, Moral Awareness, helps participants identify morally difficult situations and recognize the professional values involved. The second session, Emotional Flexibility, focuses on recognizing and responding flexibly to difficult thoughts, emotions, and patterns of experiential avoidance. The third session, Moral Repair, addresses guilt, shame, self-criticism, and attribution of responsibility, and explores possibilities for repair, learning, acceptance, support, and contextual action. The fourth session, Professional Flourishing, focuses on professional identity, strengths, values, sources of meaning, and the development of a realistic plan for professional care and protection.
The intervention uses psychoeducation, guided reflection, experiential exercises, hypothetical clinical situations, and individual worksheets. Participants are not required to disclose detailed personal or clinical experiences to the group. The emphasis is on personal application of the material while maintaining privacy and psychological safety.
This is a prospective, single-group pilot study using a pre-post design. Participants will complete assessments before the first session and after completion of the intervention. The study will examine the feasibility and acceptability of CARE-MI and explore preliminary changes in the psychological variables specified in the outcome measures section. The findings will be used to refine the intervention and inform the design of a subsequent controlled evaluation.
- Conditions
- Moral Distress, Moral Injury
- Being tested
- CARE-MI Group Intervention
- Keywords
- Clinical Psychology Residents, Group Psychological Intervention, Moral Distress, Moral Injury, Professional Well-Being, Healthcare Professionals
- 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-MI Group InterventionBehavioural
CARE-MI is a manualized group intervention consisting of four 90-minute sessions. The four components are Moral Awareness, Emotional Flexibility, Moral Repair, and Professional Flourishing. The intervention includes psychoeducation, guided reflection, experiential exercises, hypothetical clinical situations, and individual worksheets adapted for clinical psychology residents. Participants are not required to disclose detailed personal or clinical experiences to the group.
| Study group | Role | What they receive |
|---|---|---|
| CARE-MI Group Intervention | Experimental | Participants will receive the CARE-MI intervention, consisting of four 90-minute group sessions: Moral Awareness, Emotional Flexibility, Moral Repair, and Professional Flourishing. The sessions include psychoeducation, guided reflection, experiential exercises, hypothetical clinical situations, and individual worksheets adapted for clinical psychology residents. Receives: Behavioral: CARE-MI Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Moral Injury Assessed With the Health Care Moral Injury Scale
Moral injury will be assessed using the 10-item Health Care Moral Injury Scale (HMIS). Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Item scores are summed to produce a total score ranging from 10 to 50, with higher scores indicating greater moral injury. The outcome will be the change in total HMIS score from baseline to post-intervention.
Measured: Baseline and Week 4 (immediately after completion of the four-session intervention).
Secondary outcomes (5)
Change in Mental Well-Being Assessed With the Warwick-Edinburgh Mental Well-Being Scale
Mental well-being will be assessed using the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Each item is rated from 1 to 5. Item scores are summed to produce a total score ranging from 14 to 70, with higher scores indicating greater mental well-being. The outcome will be the change in total WEMWBS score from baseline to post-intervention.
Measured: Baseline and Week 4 (immediately after completion of the four-session intervention).
Change in Depressive Symptoms Assessed With the Patient Health Questionnaire-9
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Each item is rated from 0 to 3. Item scores are summed to produce a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms. The outcome will be the change in total PHQ-9 score from baseline to post-intervention.
Measured: Baseline and Week 4 (immediately after completion of the four-session intervention).
Change in Anxiety Symptoms Assessed With the Generalized Anxiety Disorder-7
Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). Each item is rated from 0 to 3. Item scores are summed to produce a total score ranging from 0 to 21, with higher scores indicating greater severity of anxiety symptoms. The outcome will be the change in total GAD-7 score from baseline to post-intervention.
Measured: Baseline and Week 4 (immediately after completion of the four-session intervention).
Intervention Completion Rate
The intervention completion rate will be calculated as the percentage of enrolled participants who attend at least three of the four CARE-MI group sessions.
Measured: From the first intervention session through Week 4.
Participant Satisfaction With the CARE-MI Intervention
Acceptability will be assessed after the intervention using a participant satisfaction questionnaire. The questionnaire will evaluate participants' perceived usefulness, relevance, comprehensibility, and overall satisfaction with the CARE-MI intervention. Higher scores will indicate greater acceptability.
Measured: Week 4 (immediately after completion of the four-session intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start10 Dec 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moral DistressStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same four-session CARE-MI group intervention. Assessments will be conducted before and after the intervention, with no concurrent comparator group.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Camilo Jose Cela University, Hospital Universitario 12 de Octubre
- Responsible party
- Sponsor
- Investigators
- Regina Espinosa López, PhD, Principal investigator, Camilo Jose Cela University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887581
- Sponsor's protocol ID
- CARE-MI-PIR
- Other IDs
- PID2024-157925OB-I00
- Acronym
- CARE-MI
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves a small and potentially identifiable professional population and the informed consent does not include public or external sharing of individual-level data. Study findings will be reported in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effects of Coping and Adaptation for Recovery From Moral Injury (CARE-MI), a Group Intervention for Clinical Psychology Residents: A Single-Group Pre-Post Pilot Study
- ClinicalTrials.gov ID
- NCT07887581
- Acronym / sponsor ID
- CARE-MI / CARE-MI-PIR
- Conditions
- Moral Distress, Moral Injury
- Keywords
- Clinical Psychology Residents, Group Psychological Intervention, Moral Distress, Moral Injury, Professional Well-Being, Healthcare Professionals
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Camilo Jose Cela University, Hospital Universitario 12 de Octubre
- Study start
- 10 Dec 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Oct 2026 (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.
Moral distress may arise when health care professionals are unable to act in accordance with their professional values or believe that they have participated in, witnessed, or been unable to prevent situations that conflict with those values. Repeated or particularly difficult experiences may affect emotional well-being, professional identity, and the meaning associated with clinical work.
This single-group pilot study will evaluate the feasibility, acceptability, and preliminary effects of Coping and Adaptation for Recovery from Moral Injury (CARE-MI), a four-session group intervention for clinical psychology residents in Spain. Each 90-minute session addresses one of four components: moral awareness, emotional flexibility, moral repair, and professional flourishing. The program is designed to help participants recognize morally difficult experiences, respond more flexibly to associated thoughts and emotions, review responsibility in a fair and contextualized way, and protect the values and resources needed for professional practice.
Participants will complete assessments before and after the intervention. Changes in moral distress and psychological well-being will be examined, together with indicators of intervention feasibility and acceptability.
Detailed description
Clinical psychology residents may encounter situations in which clinical responsibilities, patient needs, institutional constraints, supervisory decisions, or limitations in available resources conflict with deeply held professional values. These experiences can generate moral distress and may be accompanied by guilt, shame, anger, helplessness, self-criticism, reduced professional confidence, or loss of meaning in clinical work. Residents may be particularly vulnerable because they combine direct clinical responsibility with a professional role that is still developing and with dependence on supervision and organizational structures.
Coping and Adaptation for Recovery from Moral Injury (CARE-MI) is a manualized, group-based intervention designed to prevent and address the psychological impact of morally difficult professional experiences. The intervention has been adapted for clinical psychology residents, taking into account their previous psychological knowledge, their role as therapists in training, and challenges related to supervision, therapeutic responsibility, professional identity, and institutional limitations.
The program consists of four 90-minute group sessions. The first session, Moral Awareness, helps participants identify morally difficult situations and recognize the professional values involved. The second session, Emotional Flexibility, focuses on recognizing and responding flexibly to difficult thoughts, emotions, and patterns of experiential avoidance. The third session, Moral Repair, addresses guilt, shame, self-criticism, and attribution of responsibility, and explores possibilities for repair, learning, acceptance, support, and contextual action. The fourth session, Professional Flourishing, focuses on professional identity, strengths, values, sources of meaning, and the development of a realistic plan for professional care and protection.
The intervention uses psychoeducation, guided reflection, experiential exercises, hypothetical clinical situations, and individual worksheets. Participants are not required to disclose detailed personal or clinical experiences to the group. The emphasis is on personal application of the material while maintaining privacy and psychological safety.
This is a prospective, single-group pilot study using a pre-post design. Participants will complete assessments before the first session and after completion of the intervention. The study will examine the feasibility and acceptability of CARE-MI and explore preliminary changes in the psychological variables specified in the outcome measures section. The findings will be used to refine the intervention and inform the design of a subsequent controlled evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same four-session CARE-MI group intervention. Assessments will be conducted before and after the intervention, with no concurrent comparator group.
| Arm | Type | Receives |
|---|---|---|
| CARE-MI Group Intervention | Experimental | Behavioral: CARE-MI Group InterventionParticipants will receive the CARE-MI intervention, consisting of four 90-minute group sessions: Moral Awareness, Emotional Flexibility, Moral Repair, and Professional Flourishing. The sessions include psychoeducation, guided reflection, experiential exercises, hypothetical clinical situations, and individual worksheets adapted for clinical psychology residents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older.
- Currently undertaking specialized postgraduate training as a clinical psychology resident in Spain.
- Able to understand written and spoken Spanish.
- Willing and able to attend the CARE-MI group sessions and complete the study assessments.
- Able to provide informed consent.
Key exclusion criteria (4 listed)
- Not currently undertaking specialized postgraduate training as a clinical psychology resident.
- Inability to understand the study information or provide informed consent.
- Insufficient command of Spanish to participate in the group intervention or complete the assessments.
- Any acute psychological or psychiatric condition that, in the judgment of the research team, requires immediate or more intensive clinical care and would make participation in the group intervention inappropriate.
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-MI Group InterventionCARE-MI is a manualized group intervention consisting of four 90-minute sessions. The four components are Moral Awareness, Emotional Flexibility, Moral Repair, and Professional Flourishing. The intervention includes psychoeducation, guided reflection, experiential exercises, hypothetical clinical situations, and individual worksheets adapted for clinical psychology residents. Participants are not required to disclose detailed personal or clinical experiences to the group. | Behavioural | CARE-MI Group Intervention |
Primary outcome
Change in Moral Injury Assessed With the Health Care Moral Injury Scale
Time frame: Baseline and Week 4 (immediately after completion of the four-session intervention).
Moral injury will be assessed using the 10-item Health Care Moral Injury Scale (HMIS). Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Item scores are summed to produce a total score ranging from 10 to 50, with higher scores indicating greater moral injury. The outcome will be the change in total HMIS score from baseline to post-intervention.
5 secondary outcomes
Change in Mental Well-Being Assessed With the Warwick-Edinburgh Mental Well-Being Scale
Time frame: Baseline and Week 4 (immediately after completion of the four-session intervention).
Change in Depressive Symptoms Assessed With the Patient Health Questionnaire-9
Time frame: Baseline and Week 4 (immediately after completion of the four-session intervention).
Change in Anxiety Symptoms Assessed With the Generalized Anxiety Disorder-7
Time frame: Baseline and Week 4 (immediately after completion of the four-session intervention).
Intervention Completion Rate
Time frame: From the first intervention session through Week 4.
Participant Satisfaction With the CARE-MI Intervention
Time frame: Week 4 (immediately after completion of the four-session intervention).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves a small and potentially identifiable professional population and the informed consent does not include public or external sharing of individual-level data. Study findings will be reported in aggregate form.
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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.
Carmen Valiente Ots, PhD contact
Regina Espinosa López, PhD principal investigator
Camilo Jose Cela University
Questions about this trial
What is this clinical trial studying?
A study testing CARE-MI Group Intervention in people with Moral Distress and Moral Injury, run by Universidad Complutense de Madrid.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regina Espinosa López, PhD (+34 658519107, respinosa@ucjc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Moral Injury Assessed With the Health Care Moral Injury Scale (time frame: Baseline and Week 4 (immediately after completion of the four-session intervention).). 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 21 Oct 2026.