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

Официальное название

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

Обзор

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.

Подробное описание

There is growing evidence of high prevalence rates of emotional distress, including PTSD, anxiety, depression, and moral injury, among healthcare professionals, particularly those exposed to high emotional loads or critical care settings. Studies report PTSD rates ranging from 10% to 20%, and up to 30% in ICU staff. These figures increase significantly during large-scale crises such as pandemics. For instance, during the COVID-19 outbreak, rates of PTSD symptoms reached up to 54% among U.S. healthcare workers, along with 48% for depression and 30% for anxiety. Similar findings were observed in Spain and China, with high moral injury prevalence associated with anxiety and depression symptoms.

Moral injury is particularly concerning in settings with staffing shortages, where professionals feel unable to provide adequate care. This scenario extends to the mental health support network, including social and psychological care teams. In Spain, significant rates of emotional exposure (36%) and workplace violence have been reported among technical and support staff.

Although trauma-focused interventions have shown efficacy in treating PTSD, most evidence focuses on individual formats. Group interventions, however, offer a scalable, resource-efficient alternative, with promising outcomes reported for ACT, mindfulness, EMDR, and other trauma-informed approaches.

Despite this evidence, few interventions are specifically adapted and evaluated for mental health and healthcare professionals in their specific work contexts. This trial addresses this gap by evaluating the CARE-MI protocol in real-world care settings.

Вмешательства

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

Первичные конечные точки

• Change in posttraumatic stress symptoms [Срок оценки: Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]
• Change in moral injury symptoms [Срок оценки: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]

Вторичные конечные точки (8)

• Change in anxiety symptoms [Срок оценки: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Change in depressive symptoms [Срок оценки: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Change in mental wellbeing [Срок оценки: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Change in perceived meaning at work [Срок оценки: Time Frame: Baseline]
• Change in perceived ability to cope with trauma [Срок оценки: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Change in openness to the future [Срок оценки: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Change in experiential avoidance [Срок оценки: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]]
• Satisfaction with the intervention [Срок оценки: [Time Frame: Post-intervention (4 weeks)]]

Критерии участия

Критерии включения

• 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

Критерии исключения

\- None explicitly defined

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universidad Complutense — Madrid

Идентификаторы

NCT: NCT07140263 · CARE-MI-psychosocial personnel

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗