An interventional study of CARE-MI Group Intervention in Moral Distress and Moral Injury, sponsored by Universidad Complutense de Madrid. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Prevention
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.
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.
2,284 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 557 are open to participants now.
This study's planned enrollment of 10 is below the median of 70 across 1,897 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Universidad Complutense de Madrid is the lead sponsor of 202 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: CARE-MI Group Intervention
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.
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.
Time frame: Baseline and Week 4 (immediately after completion of the four-session intervention).
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 4 (immediately after completion of the four-session intervention).
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jan 2027, 1 month later.
Of 911 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 1 month is below that.
Counting every sponsor, half of 937 studies reached it within 35 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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