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Clinical Trials in Spain / NCT07140263
Enrolling by invitation Not applicable

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

NCT07140263 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2025-02-10
Last updated
2026-01-21

Condition(s) studied

Moral InjuryTEPT

Investigational drug(s) / intervention(s)

CARE MITAU: Treatment as usual

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.

TAU: Treatment as usual: During the waiting period, Waiting list group will receive usual institutional support.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: \- None explicitly defined

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Universidad Complutense Madrid Madrid

More Universidad Complutense de Madrid trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07140263 on ClinicalTrials.gov ↗ ← All trials in Spain