Psychological Trauma, Stress Disorders, Post-Traumatic; Mental Disorders
Conditions
Keywords
Psychological trauma, Trauma-focused therapy, Eye Movement Desensitization and Reprocessing, Sensorimotor Psychotherapy, Group psychotherapy, Primary care, Adults, Collaborative stepped care, Pragmatic Randomized Controlled Trial
Brief summary
Psychological trauma is common and can lead to long-lasting emotional distress, difficulties in daily functioning, and reduced quality of life. Despite the availability of effective psychological treatments, access to trauma-focused interventions in primary care remains limited. This study will evaluate the effectiveness and feasibility of a trauma-focused group intervention delivered within a collaborative stepped-care model in primary care. Adults with trauma-related symptoms will be randomly assigned to either receive the trauma-focused group intervention or treatment as usual. The intervention integrates evidence-informed principles from Eye Movement Desensitization and Reprocessing (EMDR) and Sensorimotor Psychotherapy and is delivered in a structured group format. The study hypothesizes that participants receiving the trauma-focused group intervention will show greater improvements in trauma-related symptoms, emotional regulation, psychological distress, functioning, quality of life, and treatment satisfaction than participants receiving treatment as usual. The study will also evaluate implementation outcomes, including acceptability, feasibility, and participant engagement, to determine whether this intervention can improve access to trauma-focused care within the public healthcare system.
Detailed description
Psychological trauma is highly prevalent and is associated with substantial psychiatric and physical morbidity, functional impairment, reduced quality of life, and increased healthcare utilization. In primary care, trauma-related disorders are frequently underrecognized because of their heterogeneous clinical presentation, high rates of comorbidity, and organizational barriers that limit access to evidence-based psychological treatments. Although trauma-focused interventions such as Eye Movement Desensitization and Reprocessing (EMDR) are recommended by international clinical guidelines, their implementation in routine primary care remains limited. To address this gap, this study evaluates a trauma-focused group intervention implemented within a collaborative stepped-care model in primary care. The intervention integrates evidence-informed principles from EMDR and Sensorimotor Psychotherapy within a phased treatment framework emphasizing stabilization, trauma processing, and integration. The group format was selected to improve accessibility, facilitate implementation in routine healthcare settings, and increase the capacity of public mental health services while maintaining a trauma-informed approach. This is a pragmatic randomized controlled trial conducted in adults presenting with trauma-related symptoms referred from primary care. Participants will be randomly allocated to receive either the trauma-focused group intervention or treatment as usual. Clinical assessments will be performed at baseline, post-intervention, and follow-up to evaluate changes over time. The primary objective is to determine whether the trauma-focused group intervention is more effective than treatment as usual in reducing trauma-related symptoms. Secondary objectives include evaluating improvements in emotion regulation, psychological distress, functional impairment, quality of life, and treatment satisfaction. The study will also assess implementation outcomes, including feasibility, acceptability, participant engagement, and the potential integration of the intervention within routine primary care services. This trial is intended to generate clinically relevant and implementation-focused evidence regarding the effectiveness and scalability of a trauma-focused group intervention delivered in real-world primary care. The findings may contribute to improving access to evidence-based trauma treatment and support the development of collaborative stepped-care models within public healthcare systems.
Interventions
BEHAVIORALTrauma-Focused Group Intervention
A manualized trauma-focused group intervention delivered within a collaborative stepped-care model in primary care. The intervention integrates evidence-informed principles from Eye Movement Desensitization and Reprocessing (EMDR) and Sensorimotor Psychotherapy within a phased treatment framework consisting of stabilization, trauma processing, and integration. The intervention is delivered in a structured group format.
OTHERTreatment as Usual (TAU)
Unstructured treatment as usual (TAU) according to routine clinical practice. TAU may include follow-up by clinical psychologists and/or psychiatrists within the Primary Care Collaborative Program (PCP). Healthcare contacts during the study period will be recorded.
Sponsors
Luis Eduardo Estévez Cachafeiro
Fundació Vidal i Barraquer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking is not feasible due to the nature of the psychological group intervention. Participants, therapists, and investigators are aware of treatment allocation. Outcomes are assessed using standardized self-report questionnaires completed by participants at baseline, post-intervention, and follow-up.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either an immediate trauma-focused group intervention or a wait-list control receiving treatment as usual (TAU) until the primary post-intervention assessment (T1). Randomization will be performed using permuted blocks, and stratified by (1) the presence or absence of ICD-11 Complex Post-Traumatic Stress Disorder (CPTSD), as assessed with the International Trauma Questionnaire (ITQ), and (2) time-slot availability declared before randomization (morning vs. afternoon). Clinical outcomes will be assessed at baseline (T0), post-intervention (T1), and follow-up. For ethical reasons, participants allocated to the wait-list control group will be offered the trauma-focused group intervention after completion of the T1 assessment. This pragmatic design enables evaluation of the intervention under routine primary care conditions while ensuring that all participants have access to the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently enrolled in the Primary Care Collaborative Program (PCP) of the Sant Andreu Mental Health District. * Diagnosis of post-traumatic stress disorder (PTSD) or the presence of symptoms consistent with trauma-related psychopathology, including PTSD, prolonged stress, complex PTSD (CPTSD), relational trauma, or other trauma-related symptoms associated with adverse life experiences. * Sufficient proficiency in Spanish or Catalan to understand the intervention and complete the study assessments. * Ability and willingness to provide written informed consent.
Exclusion criteria
* Acute psychotic decompensation. * Active suicidal ideation requiring immediate and intensive clinical intervention. * Unstable problematic substance use. * Unstable comorbid severe mental disorder. * Significant cognitive impairment or intellectual or physical disability that would interfere with participation in the group intervention or understanding of the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in post-traumatic stress symptom severity | Baseline (T0) and post-intervention (10 weeks) (T1) | Post-traumatic stress symptom severity will be assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), a 20-item self-report questionnaire that measures the severity of DSM-5 post-traumatic stress disorder symptoms across the domains of intrusion, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. Total scores range from 0 to 80, with higher scores indicating greater post-traumatic stress symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in general psychological distress and functioning | Baseline (T0) and post-intervention (10 weeks) (T1) | Change in general psychological distress and functioning assessed using the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), a 34-item self-report questionnaire assessing subjective well-being, psychological symptoms, functioning, and risk. Total scores range from 0 to 136, with higher scores indicating greater psychological distress and functional impairment. |
| Change in ICD-11 complex post-traumatic stress symptoms | Baseline (T0) and post-intervention (10 weeks) (T1) | Change in ICD-11 post-traumatic stress disorder (PTSD) and complex PTSD symptoms assessed using the International Trauma Questionnaire (ITQ). The ITQ is a self-report questionnaire that assesses the core PTSD symptom clusters and disturbances in self-organization, including affective dysregulation, negative self-concept, and disturbances in relationships. Higher scores indicate greater symptom severity. |
| Change in emotion regulation | Baseline (T0) and post-intervention (10 weeks) (T1) | Change in emotion regulation assessed using the Difficulties in Emotion Regulation Scale (DERS). The DERS is a self-report questionnaire assessing multiple domains of emotion regulation difficulties. Higher scores indicate greater difficulties in emotion regulation. |
| Maintenance of post-traumatic stress symptom improvement | post-intervention (10 weeks) (T1) and 3-month follow-up (T2) | Post-traumatic stress symptom severity will be assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), a 20-item self-report questionnaire that measures the severity of DSM-5 post-traumatic stress disorder symptoms across the domains of intrusion, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. Total scores range from 0 to 80, with higher scores indicating greater post-traumatic stress symptom severity. |
| Maintenance of general psychological distress | post-intervention (10 weeks) (T1) and 3-month follow-up (T2) | Change in general psychological distress and functioning assessed using the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), a 34-item self-report questionnaire assessing subjective well-being, psychological symptoms, functioning, and risk. Total scores range from 0 to 136, with higher scores indicating greater psychological distress and functional impairment. |
| Maintenance in ICD-11 complex post-traumatic stress symptoms | post-intervention (10 weeks) (T1) and 3-month follow-up (T2) | Change in ICD-11 post-traumatic stress disorder (PTSD) and complex PTSD symptoms assessed using the International Trauma Questionnaire (ITQ). The ITQ is a self-report questionnaire that assesses the core PTSD symptom clusters and disturbances in self-organization, including affective dysregulation, negative self-concept, and disturbances in relationships. Higher scores indicate greater symptom severity. |
| Maintenance in emotion regulation | post-intervention (10 weeks) (T1) and 3-month follow-up (T2) | Change in emotion regulation assessed using the Difficulties in Emotion Regulation Scale (DERS). The DERS is a self-report questionnaire assessing multiple domains of emotion regulation difficulties. Higher scores indicate greater difficulties in emotion regulation. |
| Treatment satisfaction | post-intervention (10 weeks) (T1) | Participant satisfaction with the trauma-focused group intervention will be assessed using the Client Satisfaction Scale (CRES-4), a brief self-report questionnaire evaluating participants' satisfaction with the treatment received. Higher scores indicate greater treatment satisfaction. |
Countries
Spain
Contacts
CONTACTLuis E Estévez-Cachafeiro, Clinical Psychologist
PRINCIPAL_INVESTIGATORLuis E Estévez-Cachafeiro, Clinical Psychologist
Facultat de Psicologia, Ciències de l'Educació i de l'Esport Blanquerna Universitat Ramon Llull
Outcome results
None listed