A Comprehensive Group Intervention for Psychosocial Personnel at Risk of Stress and Moral Injury

NCT07140263 | Enrolling By Invitation

• 1 other identifier: CARE-MI-psychosocial personnel
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Moral Injury; TEPT

Keywords

psychosocial personnel; moral injury intervention; CARE-MI

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

Secondary Outcomes (8)

• Change in anxiety symptoms

  [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

• Change in depressive symptoms

  [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

• Change in mental wellbeing

  [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

• Change in perceived meaning at work

  Time Frame: Baseline

• Change in perceived ability to cope with trauma

  [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

Study Arms (2)

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.

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.

Behavioral: CARE MI; Behavioral: TAU: Treatment as usual

Interventions

CARE MI BEHAVIORAL

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.

CARE MI; Waiting list (Delayed CARE-MI)

TAU: Treatment as usual BEHAVIORAL

During the waiting period, Waiting list group will receive usual institutional support.

Waiting list (Delayed CARE-MI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- None explicitly defined

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense

Madrid, Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Regina Espinosa, Full Porfessor

  Camilo Jose Cela University

  PRINCIPAL INVESTIGATOR

• Carmen Valiente, Full Porfessor

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: February 10, 2025
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES (1)