NCT07887581

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Dec 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

December 10, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

2 months

First QC Date

October 8, 2026

Last Update Submit

October 19, 2026

Conditions

Keywords

Clinical Psychology ResidentsGroup Psychological InterventionMoral DistressMoral InjuryProfessional Well-BeingHealthcare Professionals

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Baseline and Week 4 (immediately after completion of the four-session intervention).

  • Change in Depressive Symptoms Assessed With the Patient Health Questionnaire-9

    Baseline and Week 4 (immediately after completion of the four-session intervention).

  • Change in Anxiety Symptoms Assessed With the Generalized Anxiety Disorder-7

    Baseline and Week 4 (immediately after completion of the four-session intervention).

  • Intervention Completion Rate

    From the first intervention session through Week 4.

  • Participant Satisfaction With the CARE-MI Intervention

    Week 4 (immediately after completion of the four-session intervention).

Study Arms (1)

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.

Behavioral: CARE-MI Group Intervention

Interventions

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.

CARE-MI Group Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Regina Espinosa López, PhD

    Camilo Jose Cela University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Espinosa López, PhD

CONTACT

Carmen Valiente Ots, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2026

First Posted

October 21, 2026

Study Start (Estimated)

December 10, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

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.