A Comprehensive Group Intervention for Psychosocial Personnel at Risk of Stress and Moral Injury
- Conditions
- Moral InjuryTEPT
- Registration Number
- NCT07140263
- Lead Sponsor
- Universidad Complutense de Madrid
- 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.
- Detailed Description
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 (Carmassi et al., 2020). 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 (Shechter et al., 2020). 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 (British Medical Association, 2021; Liberati et al., 2021). 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 (Benavides et al., 2024).
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 (Fogliato et al., 2022; Sanz et al., 2024).
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 92
- 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 The intervention is offered under the assumption that individuals who voluntarily participate likely perceive a need for support and may benefit from the program. This approach promotes accessibility, prevention, and early intervention for healthcare professionals.
None explicitly defined; the program is designed to be inclusive and preventive. Participants with acute clinical risk (e.g., active psychosis or severe suicidal ideation) may be redirected to individual clinical care if needed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in posttraumatic stress symptoms Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Blevins et al., 2015). Higher scores indicate greater PTSD symptoms.
Change in moral injury symptoms [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up] Healthcare Moral Injury Scale (HMIS; Fradley et al., under review). Higher scores indicate higher levels of moral injury.
- Secondary Outcome Measures
Name Time Method Change in depressive symptoms [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up] Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). Higher scores indicate greater depressive symptoms.
Change in perceived meaning at work Time Frame: Baseline Work and Meaning Inventory (WAMI; Steger, 2012). Higher scores indicate greater perceived meaning.
Change in openness to the future [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up] Openness to the Future Scale (OFS; Botella et al., 2018). Higher scores indicate greater positive affective orientation toward the future.
Change in anxiety symptoms [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up] Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer et al., 2006). Higher scores indicate greater anxiety.
Change in mental wellbeing [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up] Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS; Tennant et al., 2007). Higher scores indicate better wellbeing.
Change in experiential avoidance [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up] Brief Experiential Avoidance Questionnaire (BEAQ; Gámez et al., 2014). Higher scores indicate greater experiential avoidance.
Change in perceived ability to cope with trauma [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up] Perceived Ability to Cope with Trauma Scale (PACT; Bonanno et al., 2011). Higher scores indicate greater coping flexibility.
Satisfaction with the intervention [Time Frame: Post-intervention (4 weeks)] Client Satisfaction Questionnaire-8 (CSQ-8; Larsen et al., 1979). Higher scores indicate greater satisfaction with the intervention.
Trial Locations
- Locations (1)
Universidad Complutense
🇪🇸Madrid, Spain
Universidad Complutense🇪🇸Madrid, Spain