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ENROLLING BY INVITATION
NCT07140263
NA

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

Sponsor: Universidad Complutense de Madrid

View on ClinicalTrials.gov

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.

Official title: CARE-MI: A Comprehensive Group Intervention for Psychosocial Personnel at Risk of Experiencing Symptoms of Post-traumatic Stress and/or Moral Injury Associated With Work-related Stress: Design, Implementation, and Efficacy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2025-02-10

Completion Date

2026-12-31

Last Updated

2026-01-21

Healthy Volunteers

Yes

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.

Locations (1)

Universidad Complutense

Madrid, Madrid, Spain