An interventional study of Trauma-Focused Group Intervention and Treatment as Usual (TAU) in Psychological Trauma and Stress Disorders, Post-Traumatic; Mental Disorders, sponsored by Luis Eduardo Estévez Cachafeiro. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Luis Eduardo Estévez Cachafeiro · Not applicable, Interventional, and Treatment
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.
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.
140 studies on the registry are indexed under Psychological Trauma; 43 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 108 interventional studies indexed under Psychological Trauma.
Browse Psychological Trauma studies →This is the only study on the registry with Luis Eduardo Estévez Cachafeiro as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated to this arm will receive the trauma-focused group intervention immediately after baseline assessment. The intervention is delivered within a collaborative stepped-care model in primary care and integrates evidence-informed principles from Eye Movement Desensitization and Reprocessing (EMDR) and Sensorimotor Psychotherapy. Clinical outcomes will be assessed at baseline (T0), post-intervention (T1), and follow-up.
Behavioral: Trauma-Focused Group Intervention
Participants allocated to this arm will receive treatment as usual (TAU) during the study period until completion of the primary post-intervention assessment (T1). After completion of the T1 assessment, participants will be offered the trauma-focused group intervention for ethical reasons. Clinical outcomes will be assessed at baseline (T0), post-intervention (T1), and follow-up.
Other: Treatment as Usual (TAU)
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.
Also known as: phase 1 trauma-focused group intervention
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.
Change in post-traumatic stress symptom severity
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.
Time frame: Baseline (T0) and post-intervention (10 weeks) (T1)
Change in general psychological distress and functioning
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.
Time frame: Baseline (T0) and post-intervention (10 weeks) (T1)
Change in ICD-11 complex post-traumatic stress symptoms
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.
Time frame: Baseline (T0) and post-intervention (10 weeks) (T1)
Change in emotion regulation
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.
Time frame: Baseline (T0) and post-intervention (10 weeks) (T1)
Maintenance of post-traumatic stress symptom improvement
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.
Time frame: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Maintenance of general psychological distress
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.
Time frame: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Maintenance in ICD-11 complex post-traumatic stress symptoms
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.
Time frame: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Maintenance in emotion regulation
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.
Time frame: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Treatment satisfaction
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.
Time frame: post-intervention (10 weeks) (T1)
Lifetime trauma exposure
Lifetime trauma exposure will be assessed at baseline using the International Trauma Exposure Measure (ITEM), a structured self-report questionnaire that evaluates exposure to potentially traumatic events across childhood, adolescence, and adulthood. The instrument is used to characterize cumulative trauma exposure and explore its association with treatment outcomes. Higher scores indicate greater lifetime trauma exposure.
Time frame: Baseline (T0)
Adult Attachment Representations
Adult attachment representations will be assessed at baseline using the Reduced Adult Attachment Questionnaire (CaMir-R), a self-report questionnaire assessing attachment-related cognitions, experiences with attachment figures, and family functioning across seven dimensions. The instrument provides dimensional estimates of secure, preoccupied, and avoidant attachment representations and will be used to characterize the study population and explore associations with treatment outcomes.
Time frame: Baseline (T0)
Treatment adherence
Treatment adherence will be assessed as the proportion of scheduled group sessions attended by each participant. Higher percentages indicate greater adherence to the intervention protocol.
Time frame: Throughout the intervention period (10 weeks)
Treatment completion
Treatment completion will be assessed as the number and proportion of participants who complete the intervention according to the predefined study criteria.
Time frame: post-intervention (10 weeks) (T1)
Participant retention
Participant retention will be assessed as the number and proportion of participants who complete the scheduled outcome assessments during the study. Higher retention rates indicate greater participant engagement throughout the trial.
Time frame: Baseline (T0) through 3-month follow-up (T2)
Healthcare pathway after intervention
Participants' progression within the collaborative stepped-care model will be recorded, including completion of the intervention, need for additional treatment phases, referral to higher levels of mental healthcare, or discharge following completion of the stepped-care pathway.
Time frame: Baseline (T0) through 3-month follow-up (T2)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — The investigators have not yet determined whether individual participant data will be shared. A decision will be made after study completion, taking into account ethical approvals, participant consent, institutional policies, and applicable data protection regulations.
Started Aug 2026 (actual). Primary completion is estimated for Oct 2028, 26 months after the start.
Of 82 non-industry interventional studies with no phase under Psychological Trauma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 26 months is close to that.
Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 12 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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