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

NCT07140263 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-01-21

No results posted yet for this study

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

Interventions

BEHAVIORAL

CARE MI

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.

BEHAVIORAL

TAU: Treatment as usual

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

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • Regina Espinosa, Full Porfessor · Camilo Jose Cela University

  • Carmen Valiente, Full Porfessor · Universidad Complutense de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07140263 on ClinicalTrials.gov